Abstract
Background
The leading cause of disability worldwide is low back pain. The incidence of herniated disc is approximately 5 to 20 cases per 1000 adults per year, and herniated disc is prevalent in people in their third to fifth decade of life, with a male-to-female ratio of 2:1. In Ayurveda, the condition grudhrasi is considered analogous to radiculopathy. In conventional medicine, the first line of treatment includes conservative management, such as patient education, manual therapy, and nonsteroidal anti-inflammatory drugs. Ayurvedic treatments are used to manage lumbar radiculopathy.
Objective
This clinical study aims to compare the safety and efficacy of an Ayurvedic treatment protocol with standard care in patients with lumbar disc herniation with radiculopathy.
Methods
This is an open-label, randomized, controlled, parallel group clinical trial with a sample size of 80 participants who will be randomly allocated to 2 groups. The intervention group will receive an Ayurvedic treatment protocol, and the control group will be treated with conventional care, including physiotherapy, for a period of 60 days. The changes in the numeric pain rating scale and visual analog scale score and the Oswestry Disability Index (version 2.0) score will be considered the primary outcome measures and will be recorded at baseline (day 1) and on day 8 (after completing inpatient [IP] treatment), day 30, and day 60. The secondary outcome, quality of life, will be recorded at baseline (day 1) and on day 8 (after completing IP treatment), day 30, and day 60. The occurrence of adverse events and the need for rescue analgesic medications will be considered other secondary outcome measures and will be recorded on day 8 (after completing IP treatment), day 30, and day 60.
Results
The study was funded in March 2023, and the study period is 36 months. Participant enrollment began in November 2023. A total of 136 participants were screened, of whom 80 were enrolled in the study. Data analysis is in progress, and the study outcomes are expected to be published by December 2026.
Conclusions
The outcome of this trial may provide scientific evidence regarding the safety and efficacy of Ayurvedic treatment for lumbar disc herniation with radiculopathy. The study may also contribute to the development of evidence-based integrative management strategies and standardized treatment protocols for this condition.
Trial Registration
Clinical Trial Registry of India CTRI/2023/05/052859; https://tinyurl.com/y6h4b5kb
International Registered Report Identifier (IRRID)
DERR1-10.2196/82936