Dataset Information

Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain.

ABSTRACT:

Background

Investigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain.

Methods

Randomized sham-controlled, double-blind, crossover, multicenter clinical trial. Multidisciplinary pain centres of two general hospitals. Sixty patients aged 18 or more with medical history and physical examination suggestive for lumbar disc pain and a reduction of two or more on a numerical rating scale (0-10) after a diagnostic ramus communicans test block. Treatment group: percutaneous radiofrequency treatment applied to the ramus communicans; sham: same procedure except radiofrequency treatment.

Primary outcome measure

pain reduction. Secondary outcome measure: Global Perceived Effect.

Results

No statistically significant difference in pain level over time between the groups, as well as in the group was found; however, the factor period yielded a statistically significant result. In the crossover group, 11 out of 16 patients experienced a reduction in NRS of 2 or more at 1 month (no significant deviation from chance). No statistically significant difference in satisfaction over time between the groups was found. The independent factors group and period also showed no statistically significant effects. The same applies to recovery: no statistically significant effects were found.

Conclusions

The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected. Post hoc analysis revealed that none of the investigated parameters contributed to the prediction of a significant pain reduction.

Significance

Interrupting signalling through the ramus communicans may interfere with the transition of painful information from the discs to the central nervous system. Methodological differences exist in studies evaluating the efficacy of radiofrequency treatment for lumbar disc pain. A randomized, sham-controlled, double-blind, multicenter clinical trial on the effect of radiofrequency at the ramus communicans for lumbar disc pain was conducted. The null hypothesis of no difference in pain reduction and in Global Perceived Effect between the treatment and sham group cannot be rejected.

SUBMITTER: van Tilburg CW

PROVIDER: S-EPMC5324589 | biostudies-literature | 2017 Mar

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain.

van Tilburg C W J CW Stronks D L DL Groeneweg J G JG Huygen F J P M FJ

European journal of pain (London, England) 20161013 3

<h4>Background</h4>Investigate the effect of percutaneous radiofrequency compared to a sham procedure, applied to the ramus communicans for treatment of lumbar disc pain.<h4>Methods</h4>Randomized sham-controlled, double-blind, crossover, multicenter clinical trial. Multidisciplinary pain centres of two general hospitals. Sixty patients aged 18 or more with medical history and physical examination suggestive for lumbar disc pain and a reduction of two or more on a numerical rating scale (0-10) a ...[more]

PMID: 27734550

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Project description:BackgroundIn prospective experimental studies of neck pain patients, it is difficult to determine whether responses to sham acupuncture differ from responses to real acupuncture due to the heterogeneous methodologies in control/sham interventions. Here we aim to compare the specific and nonspecific effects of electroacupuncture with four types of sham acupuncture.MethodsIn this double-blind, sham-controlled study, we randomly assigned 175 patients with neck pain to receive 10 sessions of electroacupuncture, shallow puncture, nonacupoint deep puncture, nonacupoint shallow puncture, or nonpenetration acupuncture. We used the Northwick Park Neck Pain Questionnaire (NPQ) as our primary outcome, and Short-form McGill Pain Questionnaire, visual analog scale (VAS), and Pain Threshold as secondary outcomes to measure the changes from baseline to a 3-month follow up.ResultsAll groups, except nonacupoint shallow puncture, had significant improvement in all outcome measurements. Electroacupuncture only showed superior improvements than the shallow puncture, nonacupoint shallow puncture, and nonpenetration groups when compared using the NPQ and VAS scale (*p < 0.001). Interestingly, the nonacupoint shallow puncture produced even less placebo response than nonpenetration acupuncture.ConclusionOur study demonstrates the high variability of placebo response among different types of sham controls depending on the depth of needle insertion and the puncture location. An important implication of our results is nonacupoint deep puncture produced similar analgesic effects as electroacupuncture. Our study may shed a new light on the predominant underlying mechanisms among different types of sham acupuncture controls, which can help with interpreting the effect of acupuncture in other studies.Trial registrationChinese clinical trial registry (ChiCTR-IOR-15006886).SignificanceThis study compared the observed specific and nonspecific analgesia effect in four different types of sham acupuncture stimulation with neck pain patients, assessed by four outcomes. Although all of the sham controls produced significant reduction in neck pain, electroacupuncture had superior significant improvement. Importantly, placebo responses differed significantly between the sham controls and responses were inconsistent according to different outcome assessments. This study emphasizes the importance of taking into consideration which sham control and method of outcome measurement were used in a pain research study when evaluating its results.

Dataset Information

Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain.

Background

Methods

Primary outcome measure

Results

Conclusions

Significance

Publications

Randomized sham-controlled, double-blind, multicenter clinical trial on the effect of percutaneous radiofrequency at the ramus communicans for lumbar disc pain.

Similar Datasets

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