The effect of dry needling compared to lumbar spine mobilization on functional disability, pain, quadratus lumborum and lumbar multifidus function, lumbar range of motion and pain pressure threshold in patients with non-specific chronic low back pain: Study protocol for a randomized controlled trial

Background: Low back pain (LBP) is a socioeconomic burden worldwide and a major contributor to health-care costs. Mobilization and dry needling (DN) are well-known treatments for LBP, and both of them, as a part of treatment, can relieve LBP. Objective: Due to the importance of choosing interventions with greater effects on patients' recovery, in this study we intend to compare DN and lumbar spine mobilization, as complementary therapies in combination with routine physical therapy in the treatment of patients with chronic non-specific LBP. Methods: and study design The study is a two-arm randomized, double-blind, double-dummy, controlled trial comparing DN to lumbar spine mobilization in individuals (n=56; 18–45 years of age) with chronic non-specific LBP. The experimental group will receive DN plus sham mobilization and the control group will receive Maitland’s posterior-anterior mobilization plus sham DN. Both groups will receive exercise and low-power laser. The primary outcome is functional disability, and the secondary outcomes are pain, lumbar multifidus and quadratus lumborum function, lumbar range of motion, pain pressure threshold, DN side effects, and patient adherence to treatment. Each group will receive 8 treatment sessions during 4 weeks (2 treatment sessions per week). Primary and secondary outcomes will be assessed at baseline and 3 to 7 days after the final treatment session. A mixed-model (ANCOVA) for each dependent variable will be used All the study’s processes including recruitment, primary measurement, treating patients and final measurement will be completed in 5 to 6 months. Discussion: In this study, we intend to solve the methodological problems of the previous study in this field. The results of this study allow the therapist to choose an intervention that has more therapeutic effects in combination with routine physiotherapy in the treatment of patients with chronic non-specific LBP. Trial registration 1) ClinicalTrials.gov registration number: NCT05214456. (date: 01/15/2021) 2) IRCT.ir registration number: IRCT20210706051802N1 (date: 04/27/2022).