Zoals eerder besproken, kunnen inspanningsgebonden pijnsyndromen van de onderbenen ontstaan bij activiteiten waarbij hardlopen, springen, (snel) wandelen en lang staan veel voorkomen (bijvoorbeeld: zaalsporten, danssporten, atletiek, sportopleidingen, militaire opleidingen, beveiliging). In deze richtlijn worden zes aandoeningen besproken: Medial Tibial Stress Syndrome (MTSS), Chronic Exertional Compartment Syndrome (CECS), stressfracturen, zenuwinklemming, atraumatische myogene kuitklachten, zenuwinklemming en Popliteal Artery Entrapment Syndrome (PAES). In de praktijk worden verschillende soorten behandelingen door elkaar toegepast, maar het is onduidelijk welke behandeling, of combinatie van interventies, het beste werkt bij welk syndroom, en wanneer een chirurgische behandeling (module chirurgische behandeling) kan worden overwogen.

1.1 Pain (important)

1.2 Function (critical)

1.3 Return to sport/work (critical)

1.4 Patient satisfaction about recovery (important)

1.5 Quality of life (important)

1.6 Complications/adverse events(important)

Conclusion’s orthosis and MTSS patients

2.1 Pain (critical)

2.2 Function (critical)

2.3 Return to sport/work/leisure (critical), 2.4 Patient satisfaction (about recovery) (important), quality of life (important), complications/adverse events (important)

Conclusions running versus exercises versus compression stockings in MTSS patients

3.2 Function (critical)

3.1 Pain (critical), 3.3 Return to sport/work/leisure (critical), 3.4 Patient satisfaction (with treatment) (important)3.5 Quality of life (important), 3.6 Complications/adverse events (important)

Conclusions CECS: Astym therapy versus massage

4.1 Pain (critical)

4.2 Function (critical)

4.3 Return to sport/work/leisure (critical), 4.4 Satisfaction (important), 4.5 Quality of life (important), 4.6 Complications/adverse events (important)

Six studies answered the search question. Five RCTs included patients with MTSS (medial tibial stress syndrome) and one RCT included patients with CECS (chronic exertional compartment syndrome). As different types of interventions were evaluated in these studies, we divided this summary in four parts:

1. MTSS: Extracorporeal shockwave therapy versus a control condition.
2. MTSS: Orthosis versus a control condition.
3. MTSS: Running versus exercises versus compression stockings.
4. CECS: Astym therapy versus massage .

The effectiveness of other interventions for exercise-related leg pain, such as sports tape, dry needling, acupuncture, gait retraining, ice therapy, ultrasound, or laser therapy has not been evaluated in a RCT.

1. MTSS: Extracorporeal shockwave therapy (ESWT) versus control

1. Description of studies

We found two RCTs that studied the effectiveness of ESWT in MTSS patients.

Garcia (2017) performed a single-blind RCT comparing ESWT plus an exercise programme (intervention) to an exercise programme alone (control) in Colombian military cadets diagnosed with MTSS. ESWT consisted of 1500 pulses (0.2mJ/mm²) at 5 Hz during one session. The exercise programme (muscle stretching and strengthening exercises) consisted of 40-minute training sessions and was administered 5x/week for a period of four weeks. The ESWT-group had 23 participants (mean age: 20 years, 20M/3F) and the control-group 19 participants (mean age: 19 years, 13M/6F). The authors assessed pain (VAS) after a running test, function as the duration of running, and satisfaction with treatment (Roles and Maudsley scale) over the study period of four weeks. The running test consisted of running on a treadmill at a fixed speed (10km/h). The running test was stopped if the patient indicated that the pain was too severe to continue or in case of fatigue.

Newman (2017) performed a pilot RCT comparing shockwave therapy (n=12, mean age: 34 years, 5M/7F) to sham-shockwave therapy (n=12, mean age: 36 years, 5M/7F) in active Australian adults diagnosed with MTSS. The ESWT dose progressed from 0.1 to 0.3mJ/mm² (total cumulative dose in 5 sessions was 1450mJ/mm²). The control-group received a sham-dose ESWT, which consisted of 0.01mJ/mm². The follow-up period was ten weeks. Outcomes included impairment level (pain using NRS) and participation level (self-perception of change using a global rating of change questionnaire). Pain was measured with the patient resting with an algometer (set at 5kg) to the tibia and muscle and during running with an NRS scale (0-10). The running test consisted of running on a treadmill at a fixed speed (7.5km/h for 2 minutes, followed by 10km/h) and was stopped when pain reached a NRS level of four (on a 0-10 scale) or at a maximum of 18 minutes of running.

1. Results

1.1 Pain

Both RCTs (Garcia 2017; Newman, 2017) assessed pain, but at different moments in time. Garcia (2011) used VAS and Newman (2017) used NRS.

Garcia (2017) measured pain before and after treatment, with the patient resting, or running. At rest, in the ESWT-group pain decreased from 3.78 (SE: 0.338) to 0.56 (SE: 0.206) at four weeks, whereas in the control-group pain decreased from 4.05 (SE: 0.408) to 1.47 (SE: 0.309) at four weeks (between-group analysis p=0.016). This between-group difference is statistically significant but deemed not clinically relevant.

During running, mean VAS score for the participants in the ESWT-group decreased from 6.78 (SE: 0.287) to 2.17 (SE:0.443) at four weeks, whereas the mean VAS score of the participants in the control-group decreased from 7.31 (SE: 0.412) to 4.26 (SE: 0.365) at four weeks (between-group analysis p=0.001).

Newman (2017) measured bone and muscle pain at rest with an algometer and pain during running with a subjective pain score (NRS). In the ESWT-group algometer bone pain decreased from 5.9 (SD: 2.4) to 5.3 (SD: 2.4) at ten weeks follow-up, whereas in the control-group pain decreased from 5.5 (SD: 2.0) to 3.6 (SD: 1.7), between-group difference was 1.1, 95%CI 0.0 to 2.3, p=0.05. This is a statistically significant difference, but not clinically relevant.

Regarding algometer muscle pain and running pain, nor statistically significant nor clinically relevant differences were reported: in the ESWT-group algometer muscle pain decreased from 3.6 (SD: 2.5) to 3.3 (SD: 1.6) at ten weeks follow-up, whereas the control-group decreased from 3.9 (SD: 1.8) to 3.2 (SD: 1.8), between-group difference 0.2, 95%CI -1.5 to 1.9. In the ESWT-group running pain scores decreased from 6.9 (SD: 1.3) to 3.2 (SD: 2.5) at ten weeks follow-up, whereas in the control-group running pain decreased from 6.6 (SD: 2.0) to 2.9 (SD: 3.0), between-group difference −0.1, 95%CI 2.9 to −2.7.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘pain’ started at high as it was based on RCTs but was downgraded by three levels because of study limitations (-1; risk of bias e.g., inadequate blinding) and imprecision (-2; the limited number of included patients and wide confidence intervals consisting of both no effect as well as clinical relevant effects). The level of evidence was assessed as “very low”.

1.2 Function

Both RCTs (Garcia 2017, Newman 2017) assessed function. Garcia (2011) measured the duration of running at 10km/h and Newman (2017) the distance of running until pain reached a specific level (4 on a scale of 0-10). The ESWT group in the study by Garcia (2011) was able to run for 17 min 33 s (SE: 2.36) at the end of follow-up, compared to 4 min 48 s (SE: 1.03) in the exercise-only group (p > 0.001). In the study by Newman (2017), the patients in the experimental group (n=12) could run 659 (SD 520) meters on average, and the patients in the control group (n=12) could run 1754 (1103) meters on average at week 10. There was no significant difference between groups in the pain-limited distance run (MD −583 m, 95% CI: −1260 to 94) at week 10.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘function’ started at high as it was based on RCTs but was downgraded by three levels because of study limitations (-1; risk of bias e.g., inadequate blinding) and imprecision (-2; the inclusion of a single study with a limited number of included patients). The level of evidence was assessed as “very low”.

1.3 Return to sport/work/leisure

One RCT (Garcia, 2011) assessed return to activity. Garcia (2017) reported that all patients had returned to activity and running in the military academy 4 weeks after treatment.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘return to sport/work/leisure’ started at high as it was based on an RCT but was downgraded by three levels because of study limitations (-1; risk of bias) and imprecision (-2; the inclusion of a single study with a limited number of included patients). The level of evidence was assessed as “very low”.

1.4 Satisfaction (about recovery)

The outcome measure satisfaction with recovery was not reported in the included studies.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘satisfaction’ was not assessed due to lack of data.

1.5 Quality of life

Garcia (2017) and Newman (2017) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘quality of life’ was not assessed due to lack of data.

1.6 Complications/adverse events

Both Garcia (2011) and Newman (2017) reported that no complications or adverse effects were observed in the groups. Both studies did not specify how, and which type of complications were measured.

Level of evidence of the literature

The level of evidence regarding the outcome ‘complications/adverse events’ was not graded, because no cases with complications or adverse events were reported.

2. MTSS: Orthosis versus control

2. Description of studies

We found two RCTs that studied the effectiveness of orthosis in MTSS patients.

Kachanathu (2018) performed an RCT which compared kinesio taping and exercises (n=20) to non-custom standard orthotics and exercises (n=20). All participants were diagnosed with shin splints. Both groups were asked to perform stretching and strengthening exercise three times a day for 1 week. The intervention consisted of anti-pronation kinesio taping, which was applied by a certified athletic trainer, instructed to perform this specific tape application. Orthotics (control) consisted of non-custom semi-rigid shoe insoles with medial arch support, and the participants performed the exercises with the insoles in their shoes.

Outcomes were assessed using VAS (pain free distance during a 6-metre single leg distance hop test) over a study period of one week. No statements were made regarding adverse events or complications. The study duration was 1 week, which might be too short to assess the long-term effectiveness.

Johnston (2006) performed a pilot RCT and included 25 American soldiers diagnosed with shin splints. Patients were randomly assigned to a traditional treatment plus shin orthosis group (n=12, mean age: 22) or a traditional treatment (control) group (n=13, mean age: 22). From day seven onward all participants completed a walk-to-run program. The primary outcome measure was the number of treatment days before a patient could run half a mile without pain. Maximum duration of the study was six weeks. Authors assessed running pain with a VAS score after each session. No statements were made regarding adverse events or complications. Six (46%) intervention group subjects and six (50%) control group subjects did not complete the study, due to various reasons.

Results

2.1 Pain

Both studies (Kachanathu, 2018; Johnston, 2006) assessed pain using VAS.

Kachanathu (2018) detected a statistically significant difference between the taping-group and orthotics-group at 1 week. Pain was measured during a single leg hop for distance test. In the taping-group VAS decreased from 6.26 (SD: 1.43) to 3.46 (SD: 1.18), whereas in the orthotics-group VAS decreased from 5.66 (SD: 1.63) to 4.53 (SD: 1.35). Inter-group analysis revealed significant improvement in the taping-group compared to the orthotics-group (p<0.05). This inter-group difference is statistically significant but deemed not clinically relevant.

Johnston (2006) reported that the VAS scores revealed no significant improvement in both groups, but no raw data was provided in the article.

2.2 Function

Johnston (2006) reported that there was no significant difference between treatment groups in days to finish a half mile run pain free. Kachanathu (2018) did not include this outcome.

2.3 Return to sport/work/leisure

Kachanathu (2018) and Johnston (2006) did not include this outcome.

2.4 Satisfaction about recovery

Kachanathu (2018) and Johnston (2006) did not include this outcome.

2.5 Quality of life

Kachanathu (2018) and Johnston (2006) did not include this outcome.

2.6 Complications/adverse events

Kachanathu (2018) and Johnston (2006) did not include this outcome.

2. Level of evidence of the literature

The level of evidence regarding the outcome measure ‘pain’ started at high as it was based on RCTs but was downgraded by three levels because of study limitations (-1; risk of bias e.g., inadequate blinding, relatively large loss to follow-up) and imprecision (-2; the limited number of included patients and wide confidence intervals consisting of both no effect as well as clinical relevant effects). The level of evidence was assessed as “very low”.

The level of evidence regarding the outcome measure ‘function’ started at high as it was based on RCTs but was downgraded by three levels because of study limitations (-1; risk of bias e.g., inadequate blinding, relatively large loss to follow-up) and imprecision (-2; the limited number of included patients and wide confidence intervals consisting of both no effect as well as clinical relevant effects). The level of evidence was assessed as “very low”.

The level of evidence regarding outcome measures ‘return to sport/work’, ‘patient satisfaction about recovery’, ‘quality of life’, and ‘complications/adverse events’ were not assessed due to lack of data.

3. MTSS: Running versus exercises versus compression stockings

3. Description of study

Moen (2012) performed a multicentre RCT in Dutch athletes diagnosed with MTSS. Patients were randomized into three groups. All groups performed a graded running program which consisted of a six-phase graded running program three times per week. Group one performed a graded running program only (n=25, mean age: 22, 9M/16F). Group two performed a graded running program with additional exercises (n=24, mean age: 21, 10M/14). The exercises were performed at home five times per week and consisted of stretching and strengthening exercises for the calve muscles. Group three performed a graded running program wearing compression stockings (n=25, mean age: 23, 12M/13F). The compression stockings were worn only when athletes were walking or running. The assessed outcome was the number of treatment days to reach a functional standard. Function was defined as being able to run 18 minutes outdoor consecutively at a speed in which speech becomes difficult. Follow-up took place at week 2, 4, 6, 8, 10, 12, 16, 22, 28, 34, 42, and 50.

3. Results

3.1 Pain

Moen (2012) did not include this outcome.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘pain’ was not assessed due to lack of data.

3.2 Function

Moen (2012) measured the number of days until the patient was able to complete 18 consecutive minutes of running with high intensity. Treatment duration in the running program group was 105.2 (SD: 54.6) days, in the running program with exercises group 117.6 (SD: 64.2) days, and in the running program with sports compression stocking 102.1 (SD: 52.3) days. The difference between these groups was not significant.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘function’ started at high as it was based on an RCT but was downgraded by three levels because of study limitations (risk of bias -1) and the inclusion of a single study with a limited number of included patients (imprecision, -2). The level of evidence was assessed as “very low”.

3.3 Return to sport/work/leisure

Moen (2012) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘return to sports/work/leisure’ was not assessed due to lack of data.

3.4 Satisfaction (with recovery)

Moen (2012) did not report satisfaction with recovery.

Level of evidence of the literature

The level of evidence regarding the outcome ‘satisfaction’ was not assessed due to lack of data.

3.5 Quality of life

Moen (2012) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘quality of life’ was not assessed due to lack of data.

3.6 Complications/adverse events

Moen (2012) reported that no complications or adverse effects were observed in the groups.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘complications’ was not graded because no cases with complications or adverse events were reported.

4. Description of study

Ragab (2019) performed an RCT which compared effects of Astym therapy and massage in athletes with ant-CECS. A total of 30 patients were included, clinically diagnosed with bilateral anterior chronic exertional compartment syndrome of the lower leg. 15 patients were randomly allocated to the Astym-group (intervention) and 15 patients were allocated to the massage-group (control). Astym therapy is a manual technique with specific strokes through the application of specialized instruments to enhance tissue healing, alleviate pain, and facilitate mobility. During the study period of 4 weeks, both groups received 8 sessions. In addition, all patients received a physiotherapy program including ice, ultrasound on the lower lateral leg, and stretching and strengthening exercises. Authors assessed pain (VAS) and function (Lower Extremity Functional Scale, LEFS) before starting the treatment program and at the end of the program.

4. Results

4.1 Pain

Ragab (2019) measured pain with VAS. A statistically significant difference in VAS scores was detected (p=0.03) after the four weeks study period. The Astym-group decreased from 3.18 (SD: 1.09) to 1.08 (SD: 0.61), whereas the massage-group decreased from 3.06 (SD: 0.86) to 1.68 (SD: 0.85). However, this difference is not considered clinically relevant.

Level of evidence of the literature

The level of evidence regarding the outcome measure ‘pain’ started at high as it was based on an RCT but was downgraded by three levels because of study limitations (risk of bias due to e.g., inadequate blinding, -1) and the inclusion of a single study with a limited number of included patients (imprecision, -2). The level of evidence was assessed as “very low”.

4.2 Function

Ragab (2019) measured function using a functional scale (Lower Extremity Functional Scale, LEFS) A statistically significant difference in LEFS scores was detected (p=0.001) after the four weeks study period. In the Astym-group the function score increased from 69.26 (SD: 5.33) to 79 (SD: 1.41) and the massage-group increased from 68.66 (SD: 5.78) to 74.93 (SD: 3.95).

Level of evidence of the literature

The level of evidence regarding the outcome ‘function’ started at high as it was based on an RCT but was downgraded by three levels because of study limitations (risk of bias due to e.g., inadequate blinding, -1) and the inclusion of a single study with a limited number of included patients (imprecision, -2). The level of evidence was assessed as “very low”.

4.3 Return to sport/work/leisure

Ragab (2019) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘return to sport/work/leisure’ was not assessed due to lack of data.

4.4 Satisfaction (with treatment)

Ragab (2019) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘satisfaction’ was not assessed due to lack of data.

4.5 Quality of life

Ragab (2019) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘quality of life’ was not assessed due to lack of data.

4.6 Complications/adverse events

Ragab (2019) did not include this outcome measure.

Level of evidence of the literature

The level of evidence regarding outcome measure ‘complications’ was not assessed due to lack of data.

A systematic review of literature was performed to answer the following question:

What is the comparative effectiveness of various conservative treatments in exercise-related lower leg pain syndromes on pain, function, return to sport/work/leisure, patient satisfaction about recovery, quality of life, complications/adverse events?

P:        patients with exercise-related pain syndromes of the lower leg (MTSS, CECS, stress fractures, myogenic calf complaints, nerve entrapment, PAES);

I:         conservative treatment (for example: exercise therapy, orthotics, shockwave, taping, dry needling, compression socks, acupuncture, gait retraining, ice therapy, braces, ultrasound, running therapy, laser therapy);

C:        control group/ placebo/ wait and see policy/ or other conservative treatment;

O:       pain, function/performance, return to sport/work/leisure, patient satisfaction (about recovery), quality of life, complications/adverse events.

Relevant outcome measures

The working group defined the outcome measures as following:

• 1. Pain: as determined with the Visual Analogue Scale (VAS), Numeric Rating Scale (NRS), Visual Rating Scale, or pain free run time (duration to start of pain).
• 2. Function/performance: as determined with (e.g.) PSK (“patient specifieke klachten”), Visual Analogue Scale (VAS), Numeric Rating Scale (NRS), MTSS score (Medial Tibial Stress Syndrome), SANE score (Single Assessment Numeric Evaluation), GPE score (Global Perceived Effect), or LEFS score (Lower Extremity Functional Scale).
• 3. Return to sport/work/exercise/leisure.
• 4. Patient satisfaction (about recovery).
• 5. Quality of life: as determined with the SF-36.
• 6. Complications/adverse events due to treatment.

A priori, the working group did not define the outcome measure ‘return to sport/work’, ‘patient satisfaction about recovery’, and ‘complications’, but used the definitions used in the studies.

The working group considered pain, function/performance, and return to sport/work/leisure as critical outcome measures for decision making; and quality of life, patient satisfaction (about recovery) and complications/adverse events as important outcome measures for decision making.

The working group defined a minimal clinically important difference of 2 cm (out of 10 cm) change on the VAS or NRS scale, in accordance with Crossley (2004). A minimal clinically important difference for return to sport/work, functional outcomes, patient satisfaction about recovery, and complications/adverse was not predefined and the working group used the definitions that were proposed in the studies (i.e., ad hoc assessment based on outcome measures).

Search and select (Methods)

The databases Medline, CINAHL, and Embase were searched with relevant search terms from January 2000 to September 2020. The detailed search strategy is presented under the tab Methods. The systematic literature search resulted in 877 hits. Studies were selected based on the following inclusion criteria:

• Systematic reviews of randomized controlled trials (RCTs) (searched in at least two databases, detailed search strategy, risk of bias assessment, and results of individual studies available) or RCTs.
• Answering the search question described above.
• At least 20 patients included.
• full text article available in English.

Initially, 18 studies were selected based on title and abstract screening. After reading the full text, 12 studies were excluded (see Table “reasons for exclusion”, tab Methods) and six RCTs were included.

Results

Six RCTs were included in the literature analysis. Important study characteristics and results were summarized in the evidence tables. The risk of bias assessment is presented in the risk of bias tables.