Manchikanti L, 2008, p121

double-blind RCT

Inclusion Criteria

a diagnosis of lumbar facet joint pain by means of controlled comparative local anesthetic blocks; patients who were 18 years of age; patients with a history of chronic function-limiting low back pain of at least 6 months duration; and patients who are competent to understand the study protocol  and provide voluntary, written informed consent and

participate in outcome measurements.

Also included that there was no evidence of disc-related pain and patients also have undergone and failed to improve substantially with conservative management including but not limited to physical therapy, chiropractic manipulation, exercises, drug therapy, and bedrest.

Exclusion Criteria

Lack of positive response to controlled comparative local anesthetic blocks, uncontrollable or unstable opioid use, uncontrolled psychiatric disorders, uncontrolled medical illness either acute or chronic, any conditions that could interfere with the interpretation of the outcome assessments, positioning, women who are pregnant or lactating, and patients with a history or potential for adverse reaction(s) to local anesthetic, Sarapin, or steroid.

Group I: 35% (21) male; mean age 48 ± 15; duration of pain 108 ± 102 mo; weight (lbs.) 183 ± 48.

Group II: 45% (27) male; mean age 46 ± 17; duration of pain 108 ± 102 mo; weight (lbs.) 189 ± 50.

N= 60

local anesthetic and steroid injection (group II)

Medial branch blocks with 0.25% bupivacaine and

steroid (betamethasone) (IIA) and medial branch blocks with

bupivacaine (0.25%), Sarapin, and steroid (betamethasone) (IIB)

Sarapin and bupivacaine were mixed in equal

volumes, and 0.15 mg of non-particulate betamethasone

was added per milliliter of solution for Group II.

N= 60

local anesthetic injection (group I)

Medial branch blocks with bupivacaine (0.25%) (IA)

and medial branch blocks with bupivacaine (0.25%) and

Sarapin (IB)

1) Pain relief characteristics based on Numeric Rating Scale (NRS).

2) Functional assessment measured by Oswestry Disability Index.

Thresholds for the

minimum clinical important difference for ODI varied from a 4 to 15 points change of a total score of 50.

Significant pain relief was described as 50% or more,

whereas significant improvement in function was described

as at least a 40% reduction of ODI.

Follow-up

3,6,12 month

Pain (Mean ± SD)

Group I

Baseline 8.2 ± 0.8

3 months 3.8* ± 1.3

6 months 3.6* ± 1.5

12 months 3.7* ± 1.7

Group II

Baseline  7.9 ± 1.0

3 months 3.5* ± 1.1

6 months 3.3* ± 0.8

12 months 3.5* ± 1.1

*Indicates sig. difference with baseline values

No significant differences among the groups or follow-up periods. At 3 months, 6 months, and 12 months, 82% to 93% of the patients obtained significant pain relief with no significant differences among the groups, or from the 6-month and 12-month outcomes.

OID (Mean ± SD)

Group I

Baseline 26.6 ± 4.6

3 months 12.7* ± 4.7

6 months 12.7* ± 4.7

12 months 12.3* ± 4.8

Group II

Baseline 25.9 ± 5.0

3 months 13.5* ± 5.6

6 months 12.2* ± 5.0

12 months 12.0* ± 5.4

*Indicates sig. difference with baseline values

Reduction of Oswestry scores of at least 40% was seen in 85% of the patients in Group I and 78% in Group II, whereas, a 50% reduction was seen in 70% of the patients in Group I and 65% in Group II.

Allocation concealment: +

Blinding of patients, researchers and doctors: +

Lost to follow up:+

Intention to treat:+

Eindoordeel:

+/+

Pos/neutr/neg

vergeleken met andere groep, pos ivm baseline

Manchikanti L, 2001, p101

RCT

Inclusion criteria

Chief complaint of low back pain, with or without lower extremity pain.

Exclusion criteria

Patients younger than 18 years or older than 90 years, those who exhibited neurological deficits, those who had pain for less than 6 months, those who had responded to conservative management, or those who had undergone

neural blockade in the past

Controls: 34% (11) male, 22 - 80 yrs, mean weight (lbs.) 204+11.24; mean duration of pain, 1.83+0.31

Cases:  44% (18) male, 22 – 85 yrs, mean  weight (lbs.) 174+7.70; mean duration of pain, 1.70+0.29

cases.

N= 41

therapeutic injections with a mixture of local anesthetic, Sarapin and methyl prednisolone (group II)

N= 32

therapeutic injections with a local anesthetic and Sarapin (group I)

Quality and duration of pain relief (10-point verbal pain scale).

The quality of pain relief was characterized

as less than 50% relief, or greater than 50% relief.

Pain relief greater than 50% was considered significant.

Follow-up

<= 3 Months, 4-6 Months,  7-12 Months,  >12 Months.

The duration of significant pain relief associated with each injection by members of the two groups for 10 consecutive injections.

There were no significant differences noted between the groups for each injection except with the sixth and seventh injections.

1e injection à 2 to 65 weeks relief

10e injection à 9 to 26 weeks relief

 Differences were noted from injection to injection.

Group I, significant differences were noted in the duration of relief with the seventh injection compares to the 1e injections (p=0.017), 4e injection (p=0.036), 5e injection (p=0.044), and 8e injection (p=0.048).

Group II, significant differences were noted with injections 3, 5, 6, 7 and 8 compared to the 1e injection (p=0.007, 0.008, 0.000, 0.000 0.024), injections 3, 5,6,7 and 8 compared to the 4e injection (p=0.038).

Steroids do not add to the effect of pain relief.

Allocation concealment: -

Blinding of patients, researchers and doctors: -

Loss to follow up:+

Intention to treat:-

Eindoordeel:

-/+

Pos/neutr/neg

Carette S, 1991, p1002

Doubleblind RCT

Inclusion criteria

Patients (18-65 yrs) with chronic low back pain, buttock pain, or both of at least 6 months

Patients who reported immediate relief of their pain after injections of local anesthetic into the facet joints between the fourth and fifth lumbar vertebrae and the fifth lumbar and first sacral vertebrae.

Exclusion criteria

Presence of back pain whose cause was not mechanical (rumor, infection or spondylitis for example); previous injections into the facet joints of low back surgery; pregnancy; known allergy to local anesthetic or radiologic contrast agents and the presence of a blood coagulation disorder.

N= 49

1 ml methylprednisolone acetate (20 mg) mixed with 1 ml isotonic saline

N=48

2 ml isotonic saline

1) pain on the visual-analogue scale

2) back mobility

3) limitation of function (mean sickness impact profile score)

Follow-up

1 month and 6  months

Intervention vs placebo 1 month

1) VAS: 4,5 vs 4,7 (NS)

2) overall: 9.3 vs 9.8 (ns)

3) physical dimension: 5.2 vs 6.3 (ns)

4) psychosocial: 8.2 vs 9.0 (ns)

Intervention vs placebo 6 months

1) VAS: 4 vs 5 (P<0.05)

2) overall: 7.8 vs 10.8 (ns)

3) physical dimension: 4.3 vs 7.9 (P<0.05)

4) psychosocial: 7.7 vs 9.0 (ns)

At the six-month evaluation, the patients treated with methylprednisolone reported more improvement, less pain on the visual-analogue scale, and less physical disability. The differences were reduced, however, when concurrent interventions were taken into account. Moreover, only 11 patients (22 percent) in the methylprednisolone group and 5 (10 percent) in the placebo group had sustained improvement from the first month to the sixth month (95 percent confidence interval for the difference, -2 to 26; P=0.19)

Allocation concealment: +

“randomization generated from table of numbers”

Blinding of patients, researchers and doctors: +

Loss to follow up:+

Intention to treat:?

Eindoordeel:

+/+

Pos/neutr/neg

J. Gallagher, 1994, p193

A prospective controlled double-blind randomized trial

N= 41

(gerandomiseerd)

19 reageerden niet op inclusiecriterium “response to diagnostic block”

Inclusiecriteria

Good or equivocal response to diagnostic block under X-ray screening

Low back pain for > 3 months;

Age 25-55 years;

and fulfilled the criteria for facet joint pain:

ð    Four or more of the following:

-  Tenderness on palpation;

-  More pain on extension than flexion;

-  Pain on rotation of the spine;

-  Referred pain (above the knee);

-  Pain exacerbated by exercise and relieved by rest;

-  Pain exacerbated by sitting or standing;

-  Pain not exacerbated by coughing or sneezing;

-  Radiological evidence of facet joint degeneration or predisposing factors, such as loss of disc height or spondylolisthesis at the painful level.

Exclusiecriteria

-  Previous back operations;

-  Neurological signs of nerve root; compression in the lower limbs;

-  Major mental illness or severe personality disorder;

-  General ill health.

Twee groepen patienten onderzocht:

1)      Good response to diagnostic block

2)      Equivocal response to diagnostic block

Denervation of nerves above and below the painful joint. After anaesthesizing the area with lignocaine 2 percent 0.5 ml, a radiofrequency lesion at 80˚C for 90 seconds was made.

Group A: Good response to diagnostic block (n=18)

Placebo: only injection

Group C: Good response to diagnostic block (n=12)

Pirimary

-VAS (Pijn)

Measurements:

1) Before any treatment

2) Before denervation

3) At 1 month

4) At  6 months

4 measurements, mean

VAS

Group A:

58; 51; 34*; 44*

Group C:

72; 73; 60*; 70*

* P<0.05

A: 58-44=14

B: 72-70=2

Op schaap 1 op 10 een verschil in daling van 1.2 punten in het voordeel van de Interventie groep.

*Significant verschil tussen groep A en C

Randomisatie (+)

Toewijzing verborgen (?)

Behandelaar geblindeerd (?)

Patiënt geblindeerd* (?)

Effectbeoordelaar geblindeerd (+)

Interventie- en controlegroep vergelijkbaar (+/?)

(No differences in the groups in terms of age or duration of pain)

Follow-up voldoende (≥80%) (+)

Intention-to-treat analyse (+)

Nath et al, 2008

A Randomized Double-Blind Trial

N= 40

(gerandomiseerd)

Inclusiecriteria

adult patients with continuous low back pain of at least 2 years duration, who had not responded to previous treatment.

To be eligible, patients had to be able to identify at least one component of their pain which could be attributed to one or more lumbar zygapophysial joints. Such patients had to have paravertebral tenderness, and obtain at least 80% relief of pain following controlled, medial branch blocks.

Exclusiecriteria

patients with pregnancy, coagulopathies, malignancy, infections, mental handicap, and psychiatric disorders; patients with a motor deficit or any other indication for surgical treatment; and patients who lived too far away to be able to participate in follow-up.

Intervention:

Men (n)= 6

Women (n) = 14

Mean age: 56 years (range, 36–79),

Mean duration of pain:11 years (range, 2–27)

Placebo group:

Men (n)= 9

Women (n) = 11

Mean age: 53 years (range, 37–76),

Mean duration of pain: 12 years (range, 2–51)

N=20

radiofrequency facet joint denervation.

The thermistor probe

was inserted and a 60 second lesion was performed maintaining a temperature of 85°C. The cannula was then withdrawn 5 mm and another lesion made. To accommodate possible variations

in location of the target nerve, 4 more lesions were performed

just lateral and just medial to the first 2 lesions.

N= 20

sham therapy

Pirimary

global perception of improvement (patient’s own subjective assessment on a 6-point scale.)(Functie)

relief of generalized pain, low back pain, and pain in the lower limb. (Pijn, VAS)

Secondary

range of motion of the lumbar spine, hip movement (Functie)

quality of life variables (scored by the patient on a 6-point scale) (Kwaliteit van leven)

Follow-up duur

6 months

.

global assessment

RF group improved by 1.1 U (P < 0.001)

placebo group improved by 0.3 U (P = 0.055)

Improvement difference:  0.8 U (P = 0.004).

difference btw. Baseline and 6 month; VAS

Generalized pain

RF group: - 1.93 

placebo group: - 0.38

reduction difference: 1.55 (P =  0.02)

Back pain

RF group: -2.1

placebo group: - 0.7

reduction difference: 1.4 (P =  0.08)

Leg pain

RF group: -1.6

placebo group: -0.13

reduction differences: 1.47  (P = 0.046)

Op schaap 1 op 10 een gemiddeld verschil in daling van 1.5 punten in het voordeel van de Interventie groep.

Secondary outcome

RF group: exhibited improvements that were statistically and clinically greater than those in the placebo group.

quality of life variables

mean reduction differences (RF-placebo):

0,57 (1,21 – 0,53)

Randomisatie (+)

They were randomized into an active group and a placebo group using a computer-generated randomization schedule.

Toewijzing verborgen (+)

Behandelaar geblindeerd (+)

The RF machine was placed behind the operator (S.N.) who was unaware of the current level that was operated by another person (C.N.) who was the only one of the workers who was aware of the randomization and this was never discussed between the coworkers.

Patiënt geblindeerd (+)

They (patients) remained blinded to their assignment throughout the study period.

Effectbeoordelaar geblindeerd (?)

Interventie- en controlegroep vergelijkbaar (+/-)

There were no differences between the 2 groups with respect to gender, age, or duration of pain.

à the patients in the RF group had sign. more generalized pain, low back pain, and referred pain to the leg when compared with the placebo group. All hip movements were also worse.

Follow-up

voldoende (≥80%) (+)

All 40 patients completed the study.

Intention-to-treat analyse (+)

Van Kleef et al, 1999

A prospective double-blind randomized trial

N= 31

(gerandomiseerd)

June 1994-April 1996

Inclusiecriteria

age between 20 and 60 years, chronic low back pain of more than 12 months’ duration, an initial mean VAS score of more than 4 or a VAS high score of more than 7, conservative therapy attempted without success, and absence of any neurologic deficit by routine neurologic examination.

Patients had a diagnostic dorsal ramus nerve block with a local anesthetic solution. Those patients who had at least 50% pain relief were eligible to enter the study.

Exclusiecriteria

patients who had had previous back surgery and patients with a known specific cause of

low back pain (i.e., signs of herniation, spondylolisthesis, spondylosis ankylopoetica, spinal stenosis, extensive multilevel

spondylosis, malignancy, infection, or trauma). Patients with diabetes mellitus and patients with more than one pain syndrome

Controle group:

Sex: 6M, 10F

Age, mean (SD) (yr) 41.4 (7.5)

Months of pain, median (range): 48 (12–192)

Pretreatment, mean (SD):

VAS mean 5.2 (1.6)

VAS high 7.6 (1.7)

VAS low 3.0 (1.7)

RF group:

Sex: 5M, 10F

Age, mean (SD) (yr)  46.6 (7.4)

Months of pain, median (range): 26 (12–120)

Pretreatment, mean (SD):

VAS mean 5.2 (1.7)

VAS high 7.7 (1.5)

VAS low 2.9 (1.8)

N= 15

radiofrequency therapy

Group I à a 60-second radiofrequency lesion of 80 C of the medial branch of the posterior primary ramus of the segmental nerves L3–L5 on one or on both sides.

N= 16

sham

In Group II àelectrodes were introduced as in Group I, but no RF.  Apart from the running RF the procedure was identical to the one applied in Group I.

Pirimary

VAS (0-10) (Pijn)

Global perceived effect (-3 - +3) (Pijn)

Oswestry disability scale (60 items) (Functie)

Quality of life questionnaire (7 items/ 5 point scale) (Kwaliteit van leven)

Follow-up duur

3 - 12 months after the procedure

≥ 2-points reduction

on the VAS scale (VAS-mean or VAS-high) and at ≥ 50% pain reduction on global perceived effect à treatment scored as a success.

àThe primary outcome variable was the

percentage of successes at 8 weeks

After 8 weeks of treatment; differences between sham an lesion group and 90% CI

Change VAS-mean

Mean Sham Group:

-0,43

Mean Lesion Group:

-2,37

Difference Unadjusted

 (0,24 – 3,64)

Difference Adjusted

2,46 (0,72 – 4,20)

Op schaap 1 op 10 een verschil in daling van 1.94 (2.46 ruwe data)  punten in het voordeel van de Interventie groep.

3 months

Lesion Succes: 9

Lesion Non-succes: 6

Sham Succes: 4

Sham Non-succes: 12

P-value:0,048

6 months

Lesion Succes: 7

Lesion Non-succes: 8

Sham Succes: 3

Sham Non-succes: 13

P-value:0,097

12 Months

Lesion Succes: 7

Lesion Non-succes: 8

Sham Succes: 2

Sham Non-succes: 14

P-value:0,036

Global perceived effect

Mean Sham Group:

0,37

Mean Lesion Group:

1,33

Difference Unadjusted

-0,96 (-1,7 – -0,22)

Difference Adjusted

-1,10 (-1,89 – -0,30)

Oswestry disability scale

Mean Sham Group:

1,69

Mean Lesion Group:

-11,07

Difference Unadjusted

15,75 (4,16 – 21,35)

Difference Adjusted

10,90 (1,76 – 20,0)

Quality of life questionnaire

Mean Sham Group:

-1,62

Mean Lesion Group:

-3,13

Difference Unadjusted

1,51 (-1,85 – 4,97)

Difference Adjusted

2,27 (-1,77 – 6,30)

Randomisatie (+)

Patients who met inclusiecriteria à divided in 2 strata, depending on the result of the diagnostic nerve block (good relief or free of pain) à via computer program randomization in blocks of two into two treatment groups: Group I & Group II

Toewijzing verborgen (+)

Behandelaar geblindeerd (+)

Patiënt geblindeerd (+)

The patient and operator were blinded to the study procedure

performed.

Effectbeoordelaar geblindeerd (+)

Data were obtained by an investigator blinded to the subject’s condition.

Interventie- en controlegroep vergelijkbaar (+)

There are no significant group differences in these variables (although the lesion group seemed somewhat older, used less medication, and was less disabled according to the Oswestry disability scale).

Follow-up voldoende (≥80%) (+)

Intention-to-treat analyse (+)

Because of the small number of patients, it was unlikely that by randomization all prognostic

variables were evenly distributed throughout both treatment

groups. For that reason, all analyses were performed both adjusted

and not adjusted for gender, age, duration of pain before treatment, the average pretreatment pain intensity, and Likert scores after diagnostic nerve blocks.

Tekin et al., 2007

gerandomiseerde dubbel blinde studie

Geïncludeerd:

 na een positieve proefblokkade van de mediale tak van de eerste ramus dorsalis met lidocaine 2%.

Respons werd beschouwd als positief indien er een > 50% reductie van klachten was na de proefblokkade.

radiofrequente denervatie (n=20)

controle sham laesie (n=20).

pijn (VAS)

 functie (Oswestry disability index)

follow-up

1 yr.

Mean VAS Scores

Preprocedure

Control 6.8±1.6

RF 6.5±1.5

Postprocedure

Control 4.3±1.0

RF 2.3±1.4

6mo

Control 3.1±0.8

RF 2.3±1.3

1 y

Control 3.9±1.2

RF 2.4±1.1

Na 6 mnd 0.5 punt meer daling VAS in voordeel van de RF groep.  Na 1y 1,2 punt meer daling in voordeel van de RF groep.

Mean Oswestry disability index

Preprocedure

Control 40.1±2.8

RF 39.2±3.5 

Postprocedure

Control 30.5±5.7

RF 25.6±6.5

6mo

Control 28.9±5.7

RF 25.1±6.4

 1 y

Control 33.6±5.7

RF 28.0±7.1

Na 6 mnd 2,5 % meer daling in score in voordeel van de RF groep.  Na 1y 4,8% meer daling in voordeel van de RF groep.

Randomisatie (+)

Toewijzing verborgen (+)

Behandelaar geblindeerd (?)

Patiënt geblindeerd (+)

Effectbeoordelaar geblindeerd (+)

Interventie- en controlegroep vergelijkbaar (+)

Follow-up

voldoende (≥80%) (+)

Intention-to-treat analyse (+)

Tekin et al., 2007

gerandomiseerde dubbel blinde studie

Geïncludeerd:

 na een positieve proefblokkade van de mediale tak van de eerste ramus dorsalis met lidocaine 2%.

Respons werd beschouwd als positief indien er een > 50% reductie van klachten was na de proefblokkade.

pulsed radiofrequente denervatie (n=20),

radiofrequente denervatie (n=20)

en een controle sham laesie (n=20).

pijn (VAS)

 functie (Oswestry disability index)

follow-up

1 yr.

Mean VAS Scores

Preprocedure

Control 6.8±1.6

PRF 6.6±1.6

RF 6.5±1.5

Postprocedure

Control 4.3±1.0

PRF 2.8±1.5

RF 2.3±1.4

6mo

Control 3.1±0.8

PRF 2.9±1.6

RF 2.3±1.3

Na 6 mnd 0.5 punt meer daling VAS in voordeel van controle groep

1 y

Control 3.9±1.2

PRF 3.5±1.3

RF 2.4±1.1

Mean Oswestry disability index

Preprocedure

Control 40.1±2.8

PRF 39.4±5.0

RF 39.2±3.5 

Postprocedure

Control 30.5±5.7

PRF 24.4±5.7

RF 25.6±6.5

6mo

Control 28.9±5.7

PRF 25.3±6.9

RF 25.1±6.4

 1 y

Control 33.6±5.7

PRF 28.5±6.1

RF 28.0±7.1

Randomisatie (+)

Toewijzing verborgen (+)

Behandelaar geblindeerd (?)

Patiënt geblindeerd (+)

Effectbeoordelaar geblindeerd (+)

Interventie- en controlegroep vergelijkbaar (+)

Follow-up

voldoende (≥80%) (+)

Intention-to-treat analyse (+)

Kroll et al., 2008

Prospective, randomized, double-blinded study.

Setting: Ambulatory pain clinic at a level-I trauma center and teaching institution.

Patients: 50 ASA physical status I, II, and III patients, at least 18 years of age, scheduled to undergo CRF or PRF for lumbar back pain.

Interventions: Target facet joints were identified with oblique radiographic views. Continuous

radiofrequency thermocoagulation was delivered at 80°C for 75 seconds, while PRF was delivered at 42°C with a pulse duration of 20 ms and pulse rate of two Hz for 120 seconds.

Main Results: No significant differences in the relative percentage improvement were noted between

groups in eitherVAS(P=0.46) orOSWscores (P=0.35).Within thePRFgroup, comparisons of the relative

change over time for bothVAS (P = 0.21) andOSWscores (P = 0.61) were not significant. However, within

the CRF group, VAS (P = 0.02) and OSW scores (P = 0.03) showed significant improvement.

Conclusions: Although there was no significant difference between CRF and PRF therapy in long-term

outcome in the treatment of lumbar facet syndrome, there was a greater improvement over time noted within

the CRF group.

 (n=13 )

pulsed radiofrequency (PRF)

 (n= 13)

continuous radiofrequency (CRF)

 (VAS) pain

Oswestry Low Back Pain and Disability Questionnaire (OSW)

were administered at baseline and then at three months.

Comparisons between

groups and within groups were made of the relative percentage improvement in VAS and OSW scores.

VAS

PRF

Before treatment

63.5 ± 18.3

3 mo

51.2 ± 21.5

P = 0.21

CRF

Before treatment

76.2 ± 16.0

3 mo

51.9 ± 27.4

P = 0.02

Na 3 mnd 1.2 punt meer daling VAS (schaal 0-10) in voordeel van controle groep

Oswestry scores

PRF

Before treatment

44.9 ± 10.4

3 mo

42.2 ± 19.0

P = 0.61

CRF

Before treatment

52.0 ± 17.3

3 mo

41.7 ± 16.9

P = 0.03

Randomisatie (+)

Toewijzing verborgen (+)

Behandelaar geblindeerd (?)

Patiënt geblindeerd (+)

Effectbeoordelaar geblindeerd (?)

Interventie- en controlegroep vergelijkbaar (+)

Follow-up

voldoende (≥80%)  (+)

A total of 50 patients received either CRF or PRF

treatment equally divided between the two groups. Twentysix patients (13 patients received CRF and 13 patients

received PRF) completed their follow-up evaluation and

their data were analyzed

Intention-to-treat analyse (+)