Homoeopathic treatment of sciatica pain

Phase 2/3

Completed

• Conditions: Sciatica,

• Registration Number: CTRI/2020/10/028617
• Lead Sponsor: Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

Brief Summary

Sciatica is a debilitating condition in which the patients experience pain in the distribution of the sciatic nerve or associated lumbosacral nerve root. Homeopathy is claimed to be beneficial for sciatica pain; still, systematic research evidence remains compromised. To objective of the trial was to examine the efficacy of individualized homeopathic medicines (IHMs) against identical-looking placebos in the treatment of sciatica pain. A double-blind, randomized (1:1), two parallel arms, placebo-controlled trial was conducted at Mahesh Bhattacharyya Homoeopathic Medical College and Hospital, Howrah, West Bengal, India. Participants were randomized equally to receive either verum (n = 30; IHMs plus concomitant care) or control (n = 30; placebos plus concomitant care). Primary outcome measures were Sciatica Bothersome Index (SBI) and Sciatica Frequency Index (SFI) scores; and secondary outcomes were Roland Morris Pain and Disability Questionnaire (RMPDQ), Short Form McGill Pain Questionnaire (SF-MPQ), and Oswestry Low Back Pain Questionnaire (OLBPQ) scores; all of them were measured at baseline, and every month, up to 3 months. Intention-to-treat sample (n = 60) was analyzed. Group differences were examined by two-way (split-half) repeated measure analysis of variance, primarily taking into account all the estimates measured at monthly intervals, and secondarily, by unpaired *t*-tests comparing the estimates obtained individually every month. The level of significance was set at *P* less than 0.025 and 0.05 two-tailed for the primary and secondary outcomes respectively. Group differences could not achieve significance in SBI (*P* = 0.044), SFI (*P* = 0.080), and RMPDQ scores (*P* = 0.134); but were significant for SF-MPQ (*P* = 0.007) and OLBPQ (*P* = 0.036). *Gnaphalium* *polycephalum* (n = 6; 10%) was the most frequently prescribed medicine. No harm, serious adverse events, and intercurrent illnesses were recorded in either of the groups. Although the group differences in the primary outcomes were not large enough to be statistically significant favoring homeopathy against placebos, still, promising effects were detected in the secondary outcomes and the secondary analyses. Independent replications are warranted to confirm the findings.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-27
• Study Completion: 2022-08-18
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Patients experiencing low back pain radiating to lower limb (unilateral or bilateral) since 3 months or more (2018/19 ICD-10-CM diagnosis code M54.31); confirmed by straight leg raising (SLR) test 2.
• Age range 18-65 years and patients of either sex 3.
• Literate patients; ability to read and write in Bengali and/or English 4.
• Patients providing written informed consent.

Exclusion Criteria

• Patients suffering from uncontrolled diabetes mellitus, cardiovascular diseases, thyroid diseases 2.
• Patients having history of surgery to the lower back 3.
• Patients suffering from disc prolapse, psoriatic arthritis and gout, cases willing for or requiring immediate surgical intervention or already underwent any major spinal or hip surgery in last 6 months 4.
• Patients who are undergoing treatment with NSAIDs during 6 weeks prior to enrolment in the study 5.
• Spinal corticosteroid injection within 6 months 6.
• Pregnant, puerperal and lactating women 8.
• Self-reported immune-compromised state 9.
• Substance abuse and/or dependence.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sciatica bothersomeness index (SBI) and sciatica frequency index (SFI)	At baseline, every month, up to 3 months

Secondary Outcome Measures

Name	Time	Method
Roland Morris pain and disability questionnaire (RMPDQ)	At baseline, every month, up to 3 months
Short form McGill pain questionnaire (SF-MPQ)	At baseline, every month, up to 3 months
Oswestry LBP questionnaire	At baseline, every month, up to 3 months

Trial Locations

Locations (1)

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital; 🇮🇳 Haora, WEST BENGAL, India

Mahesh Bhattacharyya Homoeopathic Medical College and Hospital

🇮🇳Haora, WEST BENGAL, India

Siddharth Kumar Das

Principal investigator

8981835382

dassiddharthkumar@gmail.com