Perifere non-invasieve elektrostimulatie – bij cerebrale spasticiteit
Uitgangsvraag
Wat is de plaats van perifere non-invasieve elektrostimulatie bij de behandeling van volwassenen met cerebrale spasticiteit?
Aanbeveling
Overweeg T(E)NS of NM(E)S als co-interventie naast oefentherapie bij cerebrale en/of spinale spasticiteit om spiertonus te verlagen en passieve ROM tijdelijk te vergroten bij patiënten in alle fasen na een CVA.
Bespreek daarbij de praktische haalbaarheid en de kosten die de patiënt zelf moet dragen.
Overwegingen
Voor- en nadelen van de interventie en de kwaliteit van het bewijs
Een literatuuronderzoek is uitgevoerd naar de effectiviteit van elektrostimulatie bij patiënten met cerebrale spasticiteit als gevolg van een CVA. Voor T(E)NS werd een matig sterke bewijskracht gevonden voor de vermindering van spasticiteit in de onderste extremiteit. Voor de bovenste extremiteit en andere uitkomstmaten waren geen gegevens beschikbaar. Voor NM(E)S werd een lage bewijskracht gevonden voor een afname van spasticiteit in de onderste extremiteit en verbetering van passieve ROM. Echter de effecten waren gering <5 graden ten faveure van NM(E)S. Voor de andere uitkomstmaten waren evenmin gegevens beschikbaar.
Tijdens de vorige richtlijn (2015) waren slechts enkele RCT’s beschikbaar waarin elektrostimulatie werd onderzocht met spasticiteit als primaire uitkomstmaat. Destijds werd geen onderscheid gemaakt tussen (NM(E)S, FES of T(E)NS). In deze herziening van de richtlijn is gekeken naar nieuwe studies, maar voor NM(E)S en FES werd geen aanvullende studie van hoge kwaliteit gevonden. De studie van Stein (2015) blijft daarmee de best beschikbare wetenschappelijke onderbouwing. Sinds 2015 is de GRADE-methodiek strikter toegepast, wat heeft geleid tot een lagere bewijskracht voor NM(E)S bij cerebrale en spinale spasticiteit. Toch kan NM(E)S mogelijk een aanvullende, klinisch relevante waarde hebben bij het verminderen van spasticiteit en het verbeteren van passieve ROM bij patiënten na een CVA (Stein, 2015). Opvallend is het gebrek aan nieuwe studies van hoge kwaliteit over NM(E)S en FES. Mogelijk komt dit doordat deze vormen van elektrostimulatie tegenwoordig vaker toegepast worden om functionaliteit te verbeteren, in plaats van primair spasticiteit te verminderen.
Nieuwe inzichten over T(E)NS en spasticiteit
Het literatuuronderzoek laat wel nieuwe studies zien over het effect van T(E)NS als adjuvante behandeling naast oefentherapie op spasticiteit. Een meta-analyse van Mahmood (2019) beschreef studies over het effect van T(E)NS op spasticiteit in de onderste extremiteit na een CVA (Mahmood 2019). Het veronderstelde werkingsmechanisme van T(E)NS omvat: modulatie van reciproke inhibitie, vermindering van de prikkelbaarheid van strekreflexen en toename van presynaptische inhibitie. Uit de meta-analyses bleek T(E)NS in combinatie met fysieke training effectiever was in het verminderen van spasticiteit in de enkel plantairflexoren dan placebo T(E)NS met dezelfde fysieke training. In de meeste studies werd T(E)NS toegepast op de antagonisten (niet op de spastische agonisten), gebaseerd op het principe van reciproke inhibitie. Mahmood (2019) rapporteerde ook tegenstrijdige bewijzen voor de effectiviteit van T(E)NS, wat mogelijk te wijten is aan: verschillen tussen de onderzoekspopulaties, variatie in T(E)NS -parameters (frequentie, duur, intensiteit) en gebruik van verschillende uitkomstmaten. De onderzochte T(E)NS -parameters varieerden van frequentie van 1,7-100 Hz, duur per sessie: van 15 minuten tot 60 minuten en aantal sessies, van 1 tot 30 sessies. Voor de vermindering van spasticiteit in de enkel plantairflexoren werden gunstige uitkomsten geassocieerd met: hoge frequentie (90-100 Hz), langere sessieduur (>30 min), langere interventieduur (>2 weken), intensiteit tweemaal de sensorische drempelwaarde en elektrodeplaatsing langs de zenuw of spierbuik. Aangezien er geen consensus bestaat over gestandaardiseerde T(E)NS-protocollen voor spasticiteitsmanagement, blijft verdere studie noodzakelijk. Een voordeel van T(E)NS is het gebrek aan bijwerkingen, in tegenstelling tot sommige andere behandelingen voor spasticiteit.
Duur en bestendigheid van het effect
Slechts één studie rapporteerde een blijvend effect tot vier weken na stopzetting. Een andere studie vond dat het effect na één dag verdween. Hier werd T(E)NS echter slechts éénmaal toegepast, wat mogelijk een te lage therapiefrequentie was. Gezien de veronderstelling, dat langdurige T(E)NS toepassing de prikkelbaarheid van de rekreflex vermindert, is het onwaarschijnlijk dat een eenmalige sessie een blijvend effect heeft. Er is onvoldoende onderzoek naar de langetermijneffecten T(E)NS.
T(E)NS voorafgaand aan fysieke training
Diverse studies toonden aan dat een T(E)NS-sessie vóór fysieke training kan leiden tot betere motoriek, coördinatie en spierkracht, wat resulteert in een effectievere training en een verminderde spasticiteit). Dit kan positieve effecten hebben op spasticiteit, statische balans, loopsnelheid, stapgrootte en opstaan en gaan zitten. De langetermijneffecten hiervan zijn echter nog niet onderzocht. Waarschijnlijk moet T(E)NS regelmatige (twee tot drie 3 keer per week) worden toegepast om het effect te behouden. De effectiviteit van T(E)NS zal bovendien toenemen wanneer het wordt gecombineerd met taakgerichte fysieke training zoals looptraining, balanstraining etc. Tot nu toe zijn deze resultaten RCTs voornamelijk onderzocht in de onderste extremiteit. Er zijn nog geen RCTs over het effect van T(E)NS op spasticiteit in de bovenste extremiteit.
Waarden en voorkeuren van patiënten (en evt. hun verzorgers)
Een belangrijke overweging bij het inzetten van T(E)NS is de toepasbaarheid in de thuissituatie. T(E)NS maakt zelfstandig thuis oefenen mogelijk, maar vereist:
- Aanschaf van een T(E)NS-apparaat en bijbehorende elektroden (die regelmatig vervangen moeten worden).
- De patiënt (of mantelzorger/verzorger) kan de elektroden zelf aanbrengen en het apparaat aansluiten en bedienen.
- Discipline om dit minimaal 2-3 per week te gebruiken.
Omdat er geen standaard behandelprotocol bestaat, moet het gebruik per patiënt worden afgestemd.
Kosten (middelenbeslag)
De kosten van een T(E)NS-apparaat, elektroden en batterijen/oplader vallen buiten de zorgverzekering in een poliklinische setting en zijn voor rekening van de patiënt.
Aanvaardbaarheid, haalbaarheid en implementatie
Het gebruik van T(E)NS of NM(E)S is beperkt doordat de patiënt het apparaat in de thuissituatie zelf moet aanschaffen en bedienen. Bovendien moet de behandeling steeds herhaald worden.
Rationale van de aanbeveling: weging van argumenten voor en tegen de interventies
T(E)NS, en in mindere mate NM(E)S, kan in combinatie met oefentherapie spiertonus verminderen en de ROM in de onderste extremiteit verbeteren na een CVA. Dit kan indirect bijdragen aan een betere functionaliteit doordat patiënten makkelijker fysiek kunnen trainen. Er zijn geen nadelige effecten gerapporteerd, maar wel kosten en praktische eisen zoals herhaald gebruik en bediening. Toepassing als aanvullende behandeling wordt aanbevolen, met monitoring van spiertonus en ROM.
Onderbouwing
Conclusies / Summary of Findings
1. Effect of T(E)NS
Muscle tone
|
Moderate GRADE |
T(E)NS combined with exercise therapy is more effective in reducing spasticity in the most affected lower limb (specifically the ankle plantar flexors) when compared to placebo T(E)NS or no T(E)NS combined with the same exercise therapy.
Source: Mahmood, 2019 |
|
No GRADE |
There is insufficient evidence that the use of T(E)NS in combination with other therapies has a beneficial effect on muscle tone in the upper extremity.
Source: Mahmood, 2019 |
Range of motion
|
No GRADE |
There is insufficient evidence that the use of T(E)NS in combination with other therapies has a beneficial effect on ROM of the most affected limb when compared to a control condition.
Source: Mahmood, 2019 |
Daily tasks and activities
|
No GRADE |
There is insufficient evidence that the use of T(E)NS in combination with other therapies has a beneficial effect on gait velocity or balance (postural sway).
Source: Mahmood, 2019 |
2. Effect of NM(E)S
Muscle tone
|
LOW GRADE |
NM(E)S alone or combined with exercise therapy slightly reduces spasticity in the most affected lower limb compared to a control condition.
Source: Stein, 2015 |
Passive range of motion
|
Low GRADE |
NM(E)S combined with exercise therapy causes a small, but clinically relevant improvement on passive range of motion of the most affected limb when compared to a control condition.
Source: Stein, 2015 |
Daily tasks and activities
|
NO GRADE |
There are no studies showing effects of NM(E)S combined with exercise therapy on outcome of functional tasks or daily activities post stroke.
Source: Stein, 2015 |
Samenvatting literatuur
Description of studies
In total 2 studies were included in this module:
- Mahmood (2019) – A systematic review examining the effects of transcutaneous electrical nerve stimulation (T(E)NS) on post-stroke spasticity.
- Stein (2015) – A systematic review assessing the impact of neuromuscular electrical stimulation (NM(E)S) on spasticity following a stroke.
Both studies are addressed below.
Mahmood 2019: effect of T(E)NS on spasticity in upper and/or lower limb in people post stroke
A systematic literature search was conducted using the electronic databases Pubmed, Pedro, CINAHL, Web of Science, CENTRAL and Embase, covering publications from their inception until March 2017.
This review included 10 RCTs, with five of these studies (Cho 2013; Jung 2017; Kim 2013; Ng 2007; Park 2014) contributing to the meta-analysis of spasticity effects, see Table 2. Studies were included if they met the following conditions:
- Participants were adults in the acute (1-7 days), early subacute (7 days -3 months), late subacute (3 – 6 months) or chronic (>6months) phase post stroke.
- Subjects exhibited spasticity in the upper and/or lower limb.
- The study investigated the effects of T(E)NS on spasticity, either as a standalone intervention or in combination with other treatments such ase exercise therapy, rehabilitation techniques (like inhibition and facilitation approaches, electrotherapy modalities, pharmaceutical treatments, or surgical interventions. Outcomes assessed were: 1) clinical assessments of spasticity such as Ashworth Scale, Modified Ashworth Scale, Composite Spasticity Scale (CSS), Modified Composite Spasticity Scale or Tardieu Scale and 2) neurophysiological metrics such as H-reflex and/or EMG-threshold.
Stein 2015: effect of NM(E)S and FES in lower limb after chronic stroke
A systematic literature search was conducted across covering studies published until February 2015. MEDLINE (via PubMed), EMBASE, Cochrane Central, and PEDro. Search terms included stroke, electric stimulation, and additional predefined keywords to optimize the sensitivity for identifying RCTs.
A total of 29 RCTs were included in the review, with pooled analysis evaluating the effects of NM(E)S on function and spasticity (muscle tone) following a stroke. Fourteen RCTs (total N=383) were included in the meta-analysis for the effect on spasticity, and thirteen RCTs (total N=447) were included in the meta-analysis on functional improvement. The pooled effects of NM(E)S on both function and spasticity post stroke are summarized in Table 3.
|
Study; design |
Sample size |
Area treated |
Intervention |
Comparison |
Duration of intervention |
Outcomes of interest reported Study quality assessment |
||
|
Type, N |
Characteristics, T(E)NS |
Type, N |
Characteristic |
|||||
|
Cho, 2013; Crossover RCT |
42 |
Ankle plantar flexors |
Exercise + T(E)NS N=22 |
Frequency: 100 Hz Duration: 60 min Intensity: 2-3 times of sensory threshold Pulse characteristic: width 200 µs Electrode placement: belly of gastrocnemius |
Exercise + Placebo T(E)NS N = 20 |
Electrical stimulation to the gastrocnemius |
1 day |
Outcome measure: MAS T(E)NS group showed a significantly greater reduction in spasticity of gastrocnemius, compared to placebo-T(E)NS group (p<.05). These effects returned to baseline values within 1 d. PEDro Score 7; Low risk of bias |
|
Jung 2017; RCT |
40 |
Ankle plantar flexors |
T(E)NS + Exercises N= 20 |
Frequency: 100 Hz Duration: 30 min Intensity: 2 times the sensory threshold without muscle contraction Pulse characteristic: width 200 µs Electrode placement: over the peroneal nerve on the affected side* |
Sham T(E)NS + Exercises N= 20 |
|
5d/wk, for 6 wk |
Outcome measure: Composite Spasticity Scale (CSS) CSS significantly decreased in the T(E)NS group (mean change, 2.6 ± 0.8 score) compared with the placebo stimulation group (mean change, 0.7 ± 0.8 score), (P<.001).
Low risk of bias |
|
Kim 2013; RCT |
30 |
Upper limb |
Task related training + T(E)NS N= 15 |
Frequency: 100 Hz Duration: 30 min Intensity: 2-3 times of sensory threshold Pulse characteristic: 200 µs Pulses Electrode placement: muscle belly of triceps and wrist extensors* |
Task Related Training + Placebo T(E)NS N= 15 |
|
5d/ wk for 4 wk |
Outcome measure: MAS Significant improvement was observed only in the T(E)NS + Task Related Training group (P=.011).
Moderate risk of bias |
|
Ng 2007; RCT |
80 |
Plantar flexors |
Group 2: T(E)NS N= 19 Group3: Placebo T(E)NS + Task Related Training N=20 Group 4: T(E)NS + Task Related Training N=21 |
Frequency: 100 Hz Duration: 60 min Intensity: 2-3 times of sensory stimulation Pulse characteristic: 0.2 ms square pulses
Electrode placement: 4 acupuncture points of lower leg: ST 36, LV 3, GB 34, UB 60 (peroneal nerve)* |
Group 1: no treatment N=20
|
|
5d/wk for 4 wk |
Outcome measure: CSS All 3 intervention groups showed a significantly greater reduction in plantar flexor spasticity when compared with the control group at wk 4 with improvements maintained at follow-up. When compared with the Placebo+Task Related Training group, both T(E)NS (T(E)NS and T(E)NS+Task Related Training) groups showed faster and more reduction in plantar flexor spasticity as measured by the CSS at wk 2 (P<.01).
Low risk of bias |
|
Park 2014, RCT |
29 |
Plantar flexors |
Exercise + T(E)NS, N=15 |
Frequency: 100 Hz Duration: 30 min Intensity: subsensory threshold with no sensation Pulse characteristic: width 200 µs Electrode placement: lateral and medial quadriceps and gastrocnemius on affected LE |
|
Exercise + Placebo T(E)NS, N=14 |
5 sessions/wk, for 6 wk |
Outcome measure: MAS The T(E)NS group showed more reductions of MAS than the placebo T(E)NS group (P<.05).
Moderate risk of bias |
*In these studies they assumed the principle of reciprocal inhibition, stimulating the antagonists and not the spastic agonists
Table 3. Evidence table RCTs from systematic review Stein on NM(E)S
|
Study; design |
Sample size |
Area treated |
Intervention |
Comparison |
Duration of intervention |
Outcomes of interest reported Risk of bias |
||
|
Type, N |
Characteristics, NM(E)S |
Type, N |
Characteristics |
|||||
|
Boyaci, 2013 |
31 |
Upper limb |
Group 1: Active NM(E)S N=11
Group 2: passive NM(E)S N=10 |
Group 1: active NM(E)S: Frequency: 50 Hz stimulation Duration: 45 min Intensity: patients initiate wrist/finger extension until a target threshold level of EMG activity was voluntarily achieved, which triggered the NM(E)S to assist the wrist/finger extension
Group 2: Passive NM(E)S: Frequency: 50 Hz stimulation; produces full wrist and finger extension with duty cycle of 10sec on and 15sec off. muscle to reach full ROM Pulse characteristic: 0.2 ms pulse duration, 14 sec of contraction Electrode placement: belly of wrist dorsoflexor* |
Control Group N=10
|
Control group: stimulation just above sensory threshold without motor activation.
|
5 sessions/ week 45 min/3 weeks |
Outcome measure: MAS of wrist and finger flexors and ROM of wrist and MCP’s. No significant difference was detected in wrist or finger flexor spasticity between the two stimulation applications (active vs passive). In the placebo stimulation group, there was a significant increase in wrist flexor spasticity. A significant improvement in active wrist extension was observed after both stimulation treatments compared with the control group; there was no difference between stimulation treatments.
Risk of bias: high
|
|
De Kroon, 2004 |
28 |
Upper limb |
Alternating NM(E)S on flexors and extensor muscles of the wrist N=13 |
Handmaster ES alterning on hand extensors and flexors (36Hz pulse stimulation and duty cycle of 40%; pulse duration and amplitude were adjusted individually). |
Stimulation of wrist extensors only N=15 |
Handmaster ES on hand extensors (36 Hz pulse stimulation and duty cycle of 40%; pulse duration and amplitude were adjusted individually) |
3 daily sessions for 20min for the first 10 days and then individually increased duration until a maximum of 1hr/session during 6 weeks |
Outcome measure: MAS and ROM. No significant reduction of spasticity and no significant improvement of ROM after intervention.
Risk of bias: moderate |
|
Bakhatiary and Fatemy 2008 |
35 |
Lower limb |
Bobath + infrared + NM(E)S on ankle dorsiflexors N=17
|
Infrared for 10 min, Bobath inhibitory techniques for 15 min, NM(E)S on tibialis anterior (100 Hz pulse stimulation, 0.1ms pulse duration, 0.9ms pulse interval) for 9min of submaximal muscular contraction (4sec contraction, 6sec rest)* |
Bobath + infrared N= 18 |
Infrared for 10 min and Bobath inhibitory techniques for 15 min |
20 daily sessions |
Outcome measure: MAS and ROM. Significant improvement of ROM and significant reduction of spasticity in ankle plantar flexor muscles measured with MAS.
Risk of bias: moderate. |
|
Chan 2009 |
20 |
Upper limb |
Occupational therapy + FES on finger and wrist extensors N=10 |
60 min of occupational therapy + FES 10 min stretching/mobilization, 20 min FES (40 Hz pulse stimulation, 0.2ms pulse duration, 8sec of contraction) on extensor digitorum superficialis with bilateral upper limb training tasks. Participants used a self-trigger mechanism, with an accelerometer as a motion detector, for generating an electric stimulation pattern that was synchronized with the bilateral upper limb activities during the training* |
Occupational therapy +Placebo FES N=10
|
60 min of occupational therapy: 10 min stretching/ mobilization; 20 min placebo FES on extensor digitorum superficialis with bilateral upper limb training tasks |
15 sessions of 1.5 hours |
Outcome measure: MAS and ROM. There was no significant reduction of spasticity in either intervention group or control group. After the training, the FES group had significant improvement in active ROM in wrist extension compared to the control group. Since there was no significant reduction of spasticity, it is unlikely that the improvement of ROM can be attributed to a decrease in spasticity.
Risk of bias: high |
|
Cheng 2010 |
15 |
Lower limb |
Motor training + NM(E)S on ankle dorsiflexors combined with active dorsiflexion and ambulation training N=8 |
Motor training paradigm + 30 min of NMES on tibialis anterior and common peroneal nerve (40Hz pulse stimulation, 0.2 pulse duration, 10sec of contraction and 10sec of rest) combined with active dorsiflexion movement on the rocker board while standing and 15 min of ambulation training* |
General range of motion and strength exercises N=7
|
30 min of general exercise training, 15 min of ambulation training |
3 sessions /week, duration 4 weeks |
Outcome measure: Dynamic Spasticity of ankle plantarflexors and ROM. Significant improvement of increase in ROM compared with control. The experimental group demonstrated a greater decrease in dynamic ankle spasticity at a comfortable gait speed than control.
Risk of bias: moderate |
|
Heckmann 1997 |
28 |
Upper or lower limb |
Physiotherapy + EMG triggered NM(E)S N=14
|
EMG triggered NM(E)S (80Hz of frequency, 0.3ms pulse width) on upper arm extensors, forearm hand extensors, knee flexors and ankle extensors and PT. Each group of muscles was stimulated 15 times per session.* |
Standard therapy: PT(45 min) and Occupational Therapy N=14 |
No specific description of exercises in PT or OT. |
5 sessions of 45 min/week over 4 weeks
|
Outcome measures: spasticity measured by a combined score which reflects muscle toneand deep tendon reflex activity, Pendulum test for evaluating spasticity in elbow and knee joint and ROM. Improvement in spasticity in intervention group compared to control group. Significant improvement in ROM in leg, not in wrist.
Risk of bias: very high |
|
Jong 2013 |
46 |
Upper limb |
Multidisciplinary stroke rehabilitation, and arm stretch positioning + NM(E)S N=23 (note: number of participants with spasticity was resp. 11 and 16 for elbow flexor and wrist flexor) |
multidisciplinary stroke rehabilitation and arm stretch positioning with simultaneous NM(E)S |
Multidisciplinary stroke rehabilitation, and arm stretch positioning + sham NMES |
multidisciplinary stroke rehabilitation and arm stretch positioning with simultaneous sham NM(E)S (TENS with no motor effect) |
2 sessions of 45 min/day for 8 weeks |
Outcome measures: spasticity measured by Tardieu scale and ROM. Because of using other scale of spasticity, not included in meta-analysis; however, no difference in spasticity between intervention and control group. Note: spasticity was not the main scope of the study (not all participants suffered from spasticity).
Risk of bias: low |
|
Kim and Lee 2014 |
29 |
Upper limb |
Group 1: Mirror therapy + Biofeedback-FES N=10
Group 2: Mirror therapy + FES N=10
Group 3: Control group, conventional physiotherapy program N=9 |
Group 1: Mirror therapy (physiological and object-related movements) combined with FES on the wrist extensor of the affected arm for 5 sec to induce wrist extension based on an EMG signal from the less affected arm when this arm was active and the EMG signal exceeds a certain threshold. (EMG sensor sampled at 256 Hz)
Group 2: FES adjusted to induce muscle contractions every 5 s through attachments to the distal and proximal portions of the wrist extensor digitorum and mirror therapy program, which consisted of physiological and object-related movements* |
Group 3: Conventional physical therapy program
|
Standard rehabilitation program, conventional physical therapy program |
5 sessions of 30 min/week, for 4 weeks |
Outcome measures: MAS and ROM. No significant reduction of spasticity, no significant improvement of ROM on wrist. Significant improvement of ROM on elbow.
Risk of bias: high |
|
Malhotra 2012 |
67 |
Upper limb |
Physiotherapy + NM(E)S on wrist and finger extensors* N=31 |
NM(E)S: 40Hz frequency, 0.3ms pulse width, 15sec of contraction and 15sec of rest. PT: passive, active assisted, active-strengthening and functional exercises |
Physiotherapy N=36 |
passive, active assisted, active-strengthening and functional exercises |
30 min at least 2x/day for 5 days/week for 6 weeks. |
Outcome measures: spasticity (quantified neurophysiologically by measuring muscle activity during passive extension of the wrist) and ROM No difference between intervention and control group in spasticity.
Risk of bias: low |
|
Mesci 2007 |
35 |
Lower limb |
Conventional exercise program + NM(E)S N=17 |
Conventional Exercise Program: for 45 min passive and active exercises and balance training + NM(E)S: 50 Hz of frequency, 0.4 ms of pulse width on dorsiflexors for 45 min (in addition to conventional program)* |
Conventional exercise program N=18 |
45 min passive and active exercises and balance training |
Intervention group: 5 sessions of 2x45 min/week over 4 weeks
Control group: 5 sessions of 45 min / week over 4 weeks. |
Outcome measures: MAS and ROM. There was a significant decrease in the level of MAS in NM(E)S group, no significant difference in control group. Intergroup comparison: the ankle dorsiflexion ROM degree and MAS in NM(E)S group were significantly higher than the control group.
Risk of bias: high |
|
Mesci 2009 |
40 |
Lower limb |
Conventional exercise program + NM(E)S on dorsiflexor muscles* N=20 |
Conventional exercise program: unclear which exercises, but same as control group And in addition NM(E)S: 50Hz of frequency, 0.4 ms of pulse width for 20 min |
Conventional exercise program N=20 |
Unclear which exercises. |
5 sessions/week over 4 weeks |
Outcome measures: MAS and ROM. Significant reduction of spasticity in lower leg and significant increase in ankle dorsiflexion in intervention group compared to control.
Risk of bias: high |
|
Sabut 2011 |
51 |
Lower limb |
Conventional rehabilitation program + NM(E)S N=27
|
Conventional rehabilitation techniques: neurodevelopmental facilitation techniques, PT, OT + NM(E)S on tibialis anterior for 20-30 min, 35 Hz of frequency, 0.28 ms of pulse width.* |
Conventional rehabilitation program N=24 |
Conventional rehabilitation techniques: neurodevelopmental facilitation techniques, PT, OT |
5 sessions/week of 1 hour over 12 weeks |
Outcome measures: MAS and ROM Significant reduction of spasticity in lower leg in intervention group compared to control. Significant increase in ROM in ankle in intervention group compared to control.
Risk of bias: high |
|
Sahin 2012 |
42 |
Upper limb |
Stretching + NM(E)S
|
Stretching: with PNF techniques and in addition: NM(E)S: 100 Hz of frequency, 0.1ms of pulse width on wrist extensors for 15 min* |
Stretching |
Stretching PNF techniques |
5 sessions/ week over 4 weeks of 15 min |
Outcome measures: MAS and ROM Significant reduction of spasticity in wrist muscles in intervention group compared to control. Significant increase in ROM in wrist in intervention group compared to control.
Risk of bias: low |
*In these studies they assumed the principle of reciprocal inhibition, stimulating the antagonists and not the spastic agonists
Results
A. Effects of T(E)NS
1. Muscle tone
Muscle tone was assessed using the (modified) Ashworth Scale (ranging from 0 to 5) or the Composite Spasticity Scale (CSS). Mahmood’s systematic review included 10 RCTs; with five contributing to the meta-analysis of muscle tone (Cho 2013; Jung 2017; Kim 2013; Ng 2007; Park 2014), see figure 1.
Assessment methods were: MAS (Cho 2013, Kim 2013 and Park 2014) and CSS (Jung 2017 and Ng 2007). Targeted muscle groups were: Only Kim 2013 investigated T(E)NS on the upper limb, the other four focused on the lower limb (ankle plantar flexors). All participants in the included studies were in the chronic phase post-stroke. T(E)NS, when combined with physical therapy interventions (e.g. Bobath therapy, sit-to stand training, task-related training, functional exercises, gait exercises, and range of movement exercises), was more effective at reducing lower limb spasticity compared to placebo T(E)NS combined with the same therapy (SMD -0.64; 95% confidence interval [95% CI], -0.98 to -0.31; P=.0001; I2=17%). This effect was considered clinically relevant.
Follow-up effects were described in two of the included studies; Ng (2007) reported that the effects persisted for four weeks post-T(E)NS. Cho (2013) found that the effects lasted less than a day, with spasticity returning to baseline after intervention cessation. The remaining studies did not include follow-up measurements.
electrode placement was analyzed. Placement along the course of the nerve was equally effective (SMD -1.06; 95% CI, -1.73 to -0.40; P=.002) as placement on agonist or antagonist muscle belly (SMD -0.71; 95% CI, -1.11 to -0.30; P=.0006; I2=0 %). Placement on acupuncture points was not effective for reducing spasticity (SMD -0.13; 95% CI, -0.74 to 0.49; P=.69). Findings for the duration of T(E)NS application were inconsistent; 30 minutes of T(E)NS was more effective than 60 minutes of application when compared to placebo T(E)NS (SMD -0.85; 95%CI, -1.27 to -0.44; P<.0001; I2=0%), 60 minutes of TENS was effective when compared to no T(E)NS. The differences in effectiveness may be due to variability in intervention duration and baseline spasticity levels. Mahmood (2019) concluded that T(E)NS applied for >30 minutes is more effective than shorter duration durations.
Figure 1. T(E)NS versus placebo T(E)NS as an adjunct in chronic poststroke spasticity, measured by (M)AS or CSS
2. Effect on other outcome measures and adverse events
No studies reported effects on clonus, cramps, pain or range of motion. No adverse effects of T(E)NS on spasticity were reported. Due to heterogeneous outcome measures pooled analysis for skills and abilities results was not possible. One study assessed postural sway and another measured gait velocity and a third used Timed Up and Go (TUG) test.
B. Effects of NM(E)S
1. Muscle tone
Stein’s systematic review included 14 RCTs, that evaluated muscle tone using the Modified Ashworth Scale (MAS). The results, presented in a forest plot, showed that NM(E)S either alone or in combination with other therapies, was associated with a reduction in spasticity compared with the control group (−0.30 [95% CI, −0.58 to −0.03; I2 81%]; Figure2). Control groups consisted of: sham NM(E)S or conventional exercise therapy without NM(E)S. Subgroup analyses helped explain the considerable heterogeneity observed in the results. These analyses indicated that NM(E)S reduced spasticity in the lower extremity (pooled mean difference: -0.78; 95% CI -1.02 to -0.54; I²=45%, N=179), but had no effect on spasticity in the upper extremity. Specifically, no meaningful reductions were observed at the wrist (pooled mean difference 0.12; 95% CI -0.41 to 0.64; I²=81%, N=1230, or at the elbow (pooled mean difference = -0.39; 95% CI -0.89 to 0.11; I²=54%, N=71).
Further subgroup analyses based on the type of intervention showed that NM(E)S combined with other treatment techniques led to a reduction in spasticity (pooled mean difference -0.35; 95% CI -0.63 to -0.07; I²=80%, N=334). However, this effect size was not clinically relevant. Additionally, two RCTs that had investigated NM(E)S alone found no clinically relevant effect on spasticity (pooled mean difference 0.13; 95% CI -1.53 to 1.78; I²=92%, N=49).
Figure 2. NM(E)S compared to placebo NM(E)S as an adjunct in poststroke spasticity in terms of reducing muscle tone following (M)AS
2. Range of motion (ROM)
Range of motion was evaluated with using a goniometer in 13 trials. NM(E)S or NM(E)S combined with other treatments increased range of motion compared to the control group (2.87 [95% CI, 1.18–4.56; I2 60%]; Figure 3A).
NM(E)S combined with other treatment techniques
Range of motion increased compared to the control group (2.73 [95% CI 1.07–4.39; I2 62%]; Figure 3A). The two other studies that used only NM(E)S showed no significant improvement in range of motion (6.93 [95% CI, −9.31 to 23.16; I2 62%]).
Subgroup analyses examined the effects on both active and passive range of motion. The pooled effect on passive range of motion was 3.91 (95% CI 1.43 to 6.38; I2=54%; N=265), while for active ROM it was 1.43 (95% BI -0.34 to 3.20; I2=26%; N=182). The effect on passive range of motion was clinically relevant.
Figure 3A. Meta-analysis NM(E)S combined with other treatment techniques or NM(E)S alone versus control on active ROM
Figure 3B. Meta-analysis of passive ROM after NM(E)S versus control
Figure 3C. Meta-analysis of active ROM after NMES versus control
3. Effect on other outcome measures and adverse events
None of the studies reported effects of NM(E)S on clonus or cramps, pain or skills/abilities. No adverse events were reported.
Level of evidence of the literature
The level of evidence for every outcome for T(E)NS started at high, since it was based on (a systematic review of) RCTs.
|
Outcome measure |
Domains GRADE |
Level of evidence |
|
Spasticity |
-1 imprecision (CI’s overlapping with limits of clinical relevance) |
MODERATE |
|
Effects on daily tasks and activities |
No studies available |
NO GRADE |
|
Range of motion |
No studies available |
NO GRADE |
|
Skills/abilities |
No studies available |
NO GRADE |
|
Pain |
No studies available |
NO GRADE |
|
Adverse events |
No studies available |
NO GRADE |
The level of evidence for every outcome for NM(E)S started at high, since it was based on (a systematic review of) RCTs.
|
Outcome measure |
Domains GRADE |
Level of evidence |
|
Spasticity |
-1 imprecision (Confidence interval overlaps with limits of clinical relevance), -1 risk of bias (studies that vary in quality from high to low) |
LOW GRADE |
|
Effects on daily tasks and activities |
No studies available |
NO GRADE |
|
Range of motion |
-1 imprecision (Confidence interval overlaps with limits of clinical relevance),
-1 risk of bias (studies that vary in quality from high to low) |
LOW GRADE |
|
Skills/abilities |
No studies available |
NO GRADE |
|
Pain |
No studies available |
NO GRADE |
|
Adverse events |
No studies available |
NO GRADE |
Zoeken en selecteren
A systematic review of the literature was performed to answer the following question:
What is the effectiveness of peripheral neurostimulation as compared to usual care in adults with cerebral or spinal spasticity?
| P: | Adults with cerebral or spinal spasticity |
| I: | Peripheral Neuromuscular, Transcutaneous or Functional Electrostimulation (N(E)MS, T(E)NS and FES) |
| C: | Standard care/Usual care/Sham control |
| O: | effects on body functions/ spasticity symptoms (muscle tone, ROM, clonus, pain, and muscle cramps) and subsequent effects on activities (skills and abilities) due to reduction in spasticity symptoms, side effects such as pain, bleeding, skin abnormalities, functional decline |
Relevant outcome measures
The guideline development group considered effects on spasticity symptoms and daily tasks and activities related to reduction of spasticity symptoms as crucial outcome measures for decision making; and adverse events as an important outcome measure for decision making.
The working group defined the outcome measures as shown in Table 1, According to ICF framework.
Table 1. Definitions and minimally clinical important differences for assessed outcome measures
|
Outcome units |
Outcome measures |
Definition |
Minimal clinically important difference |
|
Effects on body functions and structures (ICF-impairments) |
Muscle tone/ spasticity |
measured with the (modified) Ashworth scale (AS) or (modified) Tardieu scale (TS) |
1 point on the (m)AS, PSFS or (m)TS |
|
Clonus |
measured with clonus score, frequency, clonus reflex scale or duration |
10% difference |
|
|
Cramps and pain |
measured with Visual Analog Scale, or Numeric (Pain) Rating Scale |
1.65 point difference (scale 0 to 10) or 16.55 (scale 0 to 100) (Bahreini, 2020) |
|
|
Range of motion (ROM) |
the full movement potential of a joint, measured in degrees or linear distance |
10% or more increase in ROM |
|
|
Adverse events and patient safety |
Of specific interest were pain, bleeding, skin abnormalities, and functional decline. |
not applicable |
|
*See Glossary of terms for elaborate definitions
Methods search and select
The databases Medline (via OVID) and Embase (via Embase.com) were searched with relevant search terms from 1988 until the 31st of October 2023. The detailed search strategy is depicted under the tab Methods. The systematic literature search resulted in 265 hits. Studies were selected based on the following criteria:
- Randomized controlled trials, systematic review and/or meta-analysis, or other comparative study designs.
- Included adults with cerebral or spinal spasticity.
- Described neurostimulation as an intervention.
- Described usual/standard care or sham as a comparison.
- Described at least one of the outcome measures as described in the PICO.
Note: the terms NM(E)S, T(E)NS and FES are not used in a consistent way throughout the literature.
Overall results after electronic search
28 studies were initially selected based on title and abstract screening. After reading the full text, 24 studies were excluded (see the table with reasons for exclusion under the heading Evidence tables) and 4 studies were included: 2 for stroke (Mahmoodm 2019 and Stein, 2015), one for MS (Etoom, 2018) and one for spinal cord injury (Massey, 2022). Stein (2015) was already included in the previous version of the guideline.
Referenties
- Alashram AR, Annino G, Mercuri NB. Changes in spasticity following functional electrical stimulation cycling in patients with spinal cord injury: A systematic review. J Spinal Cord Med. 2022 Jan;45(1):10-23. doi: 10.1080/10790268.2020.1763713. Epub 2020 May 14. PMID: 32406810; PMCID: PMC8890523.
- Etoom M, Khraiwesh Y, Lena F, Hawamdeh M, Hawamdeh Z, Centonze D, Foti C. Effectiveness of Physiotherapy Interventions on Spasticity in People With Multiple Sclerosis: A Systematic Review and Meta-Analysis. Am J Phys Med Rehabil. 2018 Nov;97(11):793-807. doi: 10.1097/PHM.0000000000000970. PMID: 29794531.
- Mahmood A, Veluswamy SK, Hombali A, Mullick A, N M, Solomon JM. Effect of Transcutaneous Electrical Nerve Stimulation on Spasticity in Adults With Stroke: A Systematic Review and Meta-analysis. Arch Phys Med Rehabil. 2019 Apr;100(4):751-768. doi: 10.1016/j.apmr.2018.10.016. Epub 2018 Nov 16. PMID: 30452892.
- Massey S, Vanhoestenberghe A, Duffell L. Neurophysiological and clinical outcome measures of the impact of electrical stimulation on spasticity in spinal cord injury: Systematic review and meta-analysis. Front Rehabil Sci. 2022 Dec 16;3:1058663. doi: 10.3389/fresc.2022.1058663. PMID: 36589715; PMCID: PMC9801305.
- Stein C, Fritsch CG, Robinson C, Sbruzzi G, Plentz RD. Effects of Electrical Stimulation in Spastic Muscles After Stroke: Systematic Review and Meta-Analysis of Randomized Controlled Trials. Stroke. 2015 Aug;46(8):2197-205. doi: 10.1161/STROKEAHA.115.009633. Epub 2015 Jul 14. PMID: 26173724.
Evidence tabellen
Table of excluded studies
|
Reference |
Reason for exclusion |
|
Bekhet AH, Bochkezanian V, Saab IM, Gorgey AS. The Effects of Electrical Stimulation Parameters in Managing Spasticity After Spinal Cord Injury: A Systematic Review. Am J Phys Med Rehabil. 2019 Jun;98(6):484-499. doi: 10.1097/PHM.0000000000001064. PMID: 30300228. |
Review Bekhet FES NM(E)S was not used as it did not present pooled results. |
|
Hong Z, Sui M, Zhuang Z, Liu H, Zheng X, Cai C, Jin D. Effectiveness of Neuromuscular Electrical Stimulation on Lower Limbs of Patients With Hemiplegia After Chronic Stroke: A Systematic Review. Arch Phys Med Rehabil. 2018 May;99(5):1011-1022.e1. doi: 10.1016/j.apmr.2017.12.019. Epub 2018 Jan 31. PMID: 29357280. |
Systematic review of electrostimulation but not focused on improvement of spasticity |
|
Khanna S, Kaur J. Comparison of agonist vs. Antagonist stimulation on triceps surae spasticity in spinal cord injury. Iran Rehabil J. (2017) 15 (2):117–24. doi: 10.18869/nrip.irj.15.2.117 |
Results about MAS could not be used due to lack of detail |
|
Lee YY, Lin KC, Cheng HJ, Wu CY, Hsieh YW, Chen CK. Effects of combining robot-assisted therapy with neuromuscular electrical stimulation on motor impairment, motor and daily function, and quality of life in patients with chronic stroke: a double-blinded randomized controlled trial. J Neuroeng Rehabil. 2015 Oct 31;12:96. doi: 10.1186/s12984-015-0088-3. PMID: 26520398; PMCID: PMC4628254. |
Robot-assisted therapy |
|
Sivaramakrishnan A, Solomon JM, Manikandan N. Comparison of transcutaneous electrical nerve stimulation (TENS) and functional electrical stimulation (FES) for spasticity in spinal cord injury - A pilot randomized cross-over trial. J Spinal Cord Med. 2018 Jul;41(4):397-406. doi: 10.1080/10790268.2017.1390930. Epub 2017 Oct 25. PMID: 29067867; PMCID: PMC6055976. |
Comparison of FES with TENS, other PICO |
|
van der Salm A, Veltink PH, Ijzerman MJ, Groothuis-Oudshoorn KC, Nene AV, Hermens HJ. Comparison of electric stimulation methods for reduction of triceps surae spasticity in spinal cord injury. Arch Phys Med Rehabil. 2006 Feb;87(2):222-8. doi: 10.1016/j.apmr.2005.09.024. PMID: 16442976. |
Design is not RCT |
Verantwoording
Beoordelingsdatum en geldigheid
Publicatiedatum : 06-01-2026
Beoordeeld op geldigheid : 06-01-2026
De Nederlandse Vereniging van Revalidatieartsen geeft bestuurlijke goedkeuring onder voorwaarde van autorisatie door de ALV van 17 april 2026.
Algemene gegevens
De ontwikkeling/herziening van deze richtlijnmodule werd ondersteund door het Kennisinstituut van de Federatie Medisch Specialisten (www.demedischspecialist.nl/kennisinstituut) en werd gefinancierd uit de Stichting Kwaliteitsgelden Medisch Specialisten (SKMS). De financier heeft geen enkele invloed gehad op de inhoud van de richtlijnmodule.
Samenstelling werkgroep
Voor het ontwikkelen van de richtlijnmodule is in 2023 een multidisciplinaire werkgroep ingesteld, bestaande uit vertegenwoordigers van alle relevante specialismen (zie hiervoor de Samenstelling van de werkgroep) die betrokken zijn bij de zorg voor patiënten met Cerebrale en/of spinale spasticiteit.
Werkgroep
- prof. dr. A.C.H. Geurts (voorzitter), hoogleraar neurorevalidatie, Radboud UMC en Sint Maartenskliniek, namens de Nederlandse Vereniging voor Revalidatieartsen
- drs. A.M.V. Dommisse, revalidatiearts, Isala Klinieken Zwolle, namens de Nederlandse Vereniging voor Revalidatieartsen
- drs. P.J. van Dongen, patiëntvertegenwoordiger bij Hersenletsel.nl
- Dr. M. van Eijk, specialist ouderengeneeskunde, Marnix Medisch B.V., namens Verenso
- dr. J.F.M. Fleuren, revalidatiearts, Jeroen Bosch Ziekenhuis / Tolbrug, ‘s Hertogenbosch, namens de Nederlandse Vereniging voor Revalidatieartsen
- F. van Gorp-Swart, MSc, ziekenhuisapotheker, Diakonessenhuis, Utrecht/Zeist/Doorn, namens de Nederlandse Vereniging voor Ziekenhuisapothekers
- prof. dr. G. Kwakkel, hoogleraar neurorevalidatie, Amsterdam UMC, Amsterdam, namens het Koninklijk Nederlands Genootschap voor Fysiotherapie
- drs. E. Kurt, neurochirurg, Radboud UMC en Canisius Wilhelmina Ziekenhuis, Nijmegen, namens de Nederlandse Vereniging voor Neurochirurgie
- Prof. dr. C.G.M. Meskers, hoogleraar revalidatiegeneeskunde, Amsterdam UMC, Amsterdam, namens de Nederlandse Vereniging voor Revalidatieartsen
- dr. H.A. Moser, anesthesioloog, Radboud UMC, Nijmegen en Care4homecare, Bladel, namens de Nederlandse Vereniging voor Anesthesiologie
- drs. W.P. Polomski, revalidatiearts (gepensioneerd), voorheen in Spaarne Gasthuis, Hoofddorp, namens de Nederlandse Vereniging voor Revalidatieartsen
- drs. M.N. Ruissen-Eversdijk, ergotherapeut en bewegingswetenschapper, Reade, Amsterdam, namens Ergotherapie Nederland
- dr. A.V.C.M. Zeegers, orthopedisch chirurg, Medisch Spectrum Twente, Enschede, namens de Nederlandse Orthopaedische Vereniging
- dr. J.M. Zuidam, plastisch chirurg, Erasmus MC, namens de Nederlandse Vereniging voor Plastische Chirurgie
Klankbordgroep
- P.M. van Lamoen, gepensioneerd, namens Dwarslaesieorganisatie Nederland
- M. Pol, Dwarslaesie Organisatie Nederland, tot september 2024*
- Dr. A.E. Tigchelaar, Dwarslaesie Organisatie Nederland, vanaf september 2024
- Dr. W.J. Kruithof, revalidatiearts, Universitair Medisch Centrum Utrecht
- Dr. I.H. Zaal-Schuller, arts verstandelijk gehandicapten/kaderarts palliatieve zorg
*Overleden
Met ondersteuning van
- Dr. M.L. Molag, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
- Dr. M.M.J. van Rooijen, adviseur, Kennisinstituut van de Federatie Medisch Specialisten
Belangenverklaringen
De Code ter voorkoming van oneigenlijke beïnvloeding door belangenverstrengeling is gevolgd. Een overzicht van de belangen van werkgroepleden en het oordeel over het omgaan met eventuele belangen vindt u in onderstaande tabel. De ondertekende belangenverklaringen zijn op te vragen bij het secretariaat van het Kennisinstituut van de Federatie Medisch Specialisten via secretariaat@kennisinstituut.nl.
|
Werkgroeplid |
Functie |
Nevenfuncties |
Gemelde belangen |
Ondernomen actie |
|
Geurts (voorzitter) |
Hoogleraar neurorevalidatie, Radboud UMC, Nijmegen en Sint Maartenskliniek |
|
Geen. |
Geen restricties. |
|
Dommisse |
Revalidatiearts, Vogellanden |
Geen |
Speakerfee bij Ipsen farmaceutica voor:
|
Geen restricties; e-learning en presentaties betreffen de volle breedte van de behandel opties |
|
van Dongen |
Patiëntvertegenwoordiger Hersenletsel.nl |
Deelname andere werkgroepen |
Geen |
Geen restricties. |
|
van Eijk |
Specialist Ouderengeneeskunde, Marnix Medisch B.V |
|
Extern gefinancierd onderzoek over heupfracturen: 1. FITHIP; onderzoek naar valangst bij patienten met heupfractuur 2. GR HIP; onderzoek naar herstel na heupfractuur 3. HIPCARE; onderzoek naar herstel en biomarkers bij heupfractuur |
Geen restricties; De webinars waren gericht op samenwerking specialisten ouderengeneeskunde en revalidatieartsen |
|
Fleuren |
Revalidatiearts, Tolbrug |
Bestuurslid VRA (onbetaald) |
Geen. |
Geen restricties. |
|
van Gorp |
Ziekenhuisapotheker |
Lid werkgroep interacties KNMP |
Geen. |
Geen restricties. |
|
Kwakkel |
Hoogleraar neurorevalidatie, Amsterdam UMC, locatie VUMC |
|
Geen |
Geen restricties. |
|
Kurt |
Neurochirurg, Radboud UMC, Nijmegen |
Geen |
Geen |
Geen restricties. |
|
Meskers |
Revalidatiearts, Amsterdam UMC locatie VUMC |
Geen |
Geen. |
Geen restricties. |
|
Moser |
Anesthesioloog, Radboud UMC, Nijmegen en Care4homecare, Bladel |
Geen |
Geen |
Geen restricties. |
|
Polomski |
Revalidatiearts Spaarne Gasthuis (gepensioneerd vanaf 1 mei 2023). |
Geen |
Lid Adviesraad Merz Benelux, raakt niet aan de modules |
Restrictie ten aanzien van besluitvorming met betrekking tot botulinetoxine |
|
Ruissen-Eversdijk |
Ergotherapeut bij Reade Revalidatie. |
Geen. |
Geen. |
Geen restricties. |
|
Zeegers |
Orthopedisch chirurg, Medisch Spectrum Twente, Enschede (tot 1-6-2025), en UMCG (vanaf 1-6-2025) |
|
Geen. |
Geen restricties. |
|
Zuidam |
Plastisch chirurg, Erasmus MC Rotterdam |
Geen. |
Geen. |
Geen restricties. |
Inbreng patiëntenperspectief
Er werd aandacht besteed aan het patiëntenperspectief door uitnodigen van Hersenletsel.nl en Dwarslaesie Organisatie Nederland (DON) bij de schriftelijke knelpuntenanalyse. DON heeft een enquête bij hun achterban uitgezet, en knelpunten werden meegenomen in het proces. Het verslag van deze enquête is besproken in de werkgroep. De verkregen input is meegenomen bij het opstellen van de uitgangsvragen, de keuze voor de uitkomstmaten en bij het opstellen van de overwegingen. In de werkgroep heeft een vertegenwoordiger van Hersenletsel.nl deelgenomen. De conceptrichtlijn is tevens voor commentaar voorgelegd aan Hersenletsel.nl, DON, MS Nederland en Spierziekten Nederland.
Kwalitatieve raming van mogelijke financiële gevolgen in het kader van de Wkkgz
Bij de richtlijnmodule is conform de Wet kwaliteit, klachten en geschillen zorg (Wkkgz) een kwalitatieve raming uitgevoerd om te beoordelen of de aanbevelingen mogelijk leiden tot substantiële financiële gevolgen. Bij het uitvoeren van deze beoordeling is de richtlijnmodule op verschillende domeinen getoetst (zie het stroomschema op de Richtlijnendatabase). Uit deze kwalitatieve raming bleek dat er geen grote financiële gevolgen te verwachten zijn.
|
Module |
Uitkomst raming |
Toelichting |
|
Elektrostimulatie - Perifere non-invasieve elektrostimulatie - bij cerebrale spasticiteit |
geen financiële gevolgen |
Hoewel uit de toetsing volgt dat de aanbeveling(en) breed toepasbaar zijn (>40.000 patiënten), volgt ook uit de toetsing dat het geen nieuwe manier van zorgverlening of andere organisatie van zorgverlening betreft, het geen toename in het aantal in te zetten voltijdsequivalenten aan zorgverleners betreft en het geen wijziging in het opleidingsniveau van zorgpersoneel betreft. Er worden daarom geen substantiële financiële gevolgen verwacht. |
Werkwijze
Voor meer details over de gebruikte richtlijnmethodologie verwijzen wij u naar de Werkwijze. Relevante informatie voor de ontwikkeling/herziening van deze richtlijnmodule is hieronder weergegeven.