Contemporary Clinical Trials Communications (Aug 2023)
Physiotherapy combined with dry needling among patients with chronic low back pain: Study protocol for a randomized controlled clinical trial
Abstract
Background: Chronic low back pain (CLBP) is an extremely common public health concern responsible for pain-related disability. CLBP is challenging to manage despite having a plethora of treatment options. Physiotherapy is a guideline-recommended treatment for CLBP. Furthermore, some forms of complementary medicines, such as dry needling, spinal manipulation, Tai Chi, and yoga are also recommended for CLBP treatment. We hypothesized that the combined treatment would be more effective when managing CLBP. Therefore, this randomized clinical trial aims to examine the impact of combined therapy of dry needling and physiotherapy compared to the treatment effect of only physiotherapy among patients with CLBP. Methods: The study is a two-armed single-center, randomized controlled clinical superiority trial where participants are randomized to combined therapy of usual care physiotherapy and dry needling or only usual care physiotherapy (1:1). Individuals who are 18 years or older and experiencing LBP with or without leg pain for a minimum of three months will be considered eligible for the study. Pain severity, pain affective and physical interference, activity limitation, and insomnia symptoms of patients with CLBP will be measured at the baseline after four, 12 and 24-week treatment started. Conclusion: Finding a better management strategy for managing CLBP is an ongoing challenge. Most of the novel techniques that try to manage CLBP are limitedly tested. This study will allow testing of the combined effect of usual care physiotherapy and dry needling when managing CLBP in terms of clinical efficacy. If the combined therapy is proven significantly effective, compared to usual care physiotherapy alone will provide plausible evidence of an effective treatment option to manage CLBP. Trial registration: Clinical Trial Registry-India; trial registration number- CTRI/2022/09/045625.
