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Zhu L, Sun Y, Kang J, et al. Effect of Acupuncture on Neurogenic Claudication Among Patients With Degenerative Lumbar Spinal Stenosis : A Randomized Clinical Trial. Ann Intern Med. 2024 Jul 2. doi: 10.7326/M23-2749. (Original study)
Abstract

BACKGROUND: Acupuncture may improve degenerative lumbar spinal stenosis (DLSS), but evidence is insufficient.

OBJECTIVE: To investigate the effect of acupuncture for DLSS.

DESIGN: Multicenter randomized clinical trial. (ClinicalTrials.gov: NCT03784729).

SETTING: 5 hospitals in China.

PARTICIPANTS: Patients with DLSS and predominantly neurogenic claudication pain symptoms.

INTERVENTION: 18 sessions of acupuncture or sham acupuncture (SA) over 6 weeks, with 24-week follow-up after treatment.

MEASUREMENTS: The primary outcome was change from baseline in the modified Roland-Morris Disability Questionnaire ([RMDQ] score range, 0 to 24; minimal clinically important difference [MCID], 2 to 3). Secondary outcomes were the proportion of participants achieving minimal (30% reduction from baseline) and substantial (50% reduction from baseline) clinically meaningful improvement per the modified RMDQ.

RESULTS: A total of 196 participants (98 in each group) were enrolled. The mean modified RMDQ score was 12.6 (95% CI, 11.8 to 13.4) in the acupuncture group and 12.7 (CI, 12.0 to 13.3) in the SA group at baseline, and decreased to 8.1 (CI, 7.1 to 9.1) and 9.5 (CI, 8.6 to 10.4) at 6 weeks, with an adjusted difference in mean change of -1.3 (CI, -2.6 to -0.03; P = 0.044), indicating a 43.3% greater improvement compared with SA. The between-group difference in the proportion of participants achieving minimal and substantial clinically meaningful improvement was 16.0% (CI, 1.6% to 30.4%) and 12.6% (CI, -1.0% to 26.2%) at 6 weeks. Three cases of treatment-related adverse events were reported in the acupuncture group, and 3 were reported in the SA group. All events were mild and transient.

LIMITATION: The SA could produce physiologic effects.

CONCLUSION: Acupuncture may relieve pain-specific disability among patients with DLSS and predominantly neurogenic claudication pain symptoms, although the difference with SA did not reach MCID. The effects may last 24 weeks after 6-week treatment.

PRIMARY FUNDING SOURCE: 2019 National Administration of Traditional Chinese Medicine "Project of building evidence-based practice capacity for TCM-Project BEBPC-TCM" (NO. 2019XZZX-ZJ).

Ratings
Discipline Area Score
Physician 5 / 7
Comments from MORE raters

Physician rater

Interesting but not sure whether this would be widely accepted by patients re insurance, etc.

Physician rater

Such a common problem in the aging population.

Physician rater

Acupuncture may offer a safe alternative or adjunct to medications. Larger studies would be helpful.

Physician rater

In this Chinese multicenter RCT, acupuncture and sham acupuncture (SA) both reduced pain-specific disability in adult patients with neurogenic claudication pain symptoms and degenerative lumbar spinal stenosis (DLSS) after 6 weeks of therapy and at 24 weeks of follow-up. However, despite the fact that a higher proportion of patients in the acupuncture group achieved clinically meaningful improvements, the between-group differences in the primary outcome of the modified Roland-Morris Disability Questionnaire did not reach the prespecified threshold for clinical meaningfulness (minimal clinically important difference) at any time point. Thus, acupuncture is not obviously superior to SA for treating DLSS with neurogenic claudication symptoms, possibly due to physiological effects of SA, placebo effect, and using subjective outcome measures. Adverse events were mild and transient in both groups.
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