A Prospective Randomized Controlled Study of Acupuncture to Manage Pain, Self-Rated Disability, Depression, Anxiety, Stress, and Fatigue in Patients with Non-Specific Low Back Pain: A Study Protocol

Abstract

Background: Non-Specific Low Back Pain (NSLBP) is a widespread health concern that significantly affects quality of life and imposes considerable economic costs globally. Although numerous pharmacological and therapeutic interventions exist, treatment outcomes remain variable, and high disability rates persist. Conventional treatments often offer limited or transient relief, leading to increased interest in evidence-based complementary therapies. Acupuncture—the insertion of fine sterile needles at anatomically defined acupoints along established meridian pathways—has a growing evidence base across diverse pain conditions and has been recommended for low back pain in several international clinical guidelines. This study protocol describes a prospective randomized controlled trial designed to assess the efficacy and clinical applications of acupuncture in managing NSLBP, along with its associated Self-Rated Disability, Depression, Anxiety, Stress, and Fatigue.

Methods/design: For this prospective randomized controlled study, participants will be randomly assigned to two groups: (1) Intervention group—Acupuncture at eight standardized body acupoints (BL23, BL25, GV4, GB30, GB34, BL40, ST36, LR3) plus Patient Education; and (2) Control group—Usual Care comprising a supervised Therapeutic Exercise regimen, Moist Hot Packs, and Patient Education. Treatment effects will be measured via the Numerical Pain Rating Scale (NPRS), the Roland Morris Disability Questionnaire (RMDQ) in patients’ native language, the 21-question version of the Depression Anxiety Stress Scale (DASS-21) in patients’ native language, and PROMIS Fatigue Short Form 13a in patients’ native language.

Discussion: This study is expected to provide robust and clinically relevant evidence on the effect of body acupuncture on the multidimensional symptom burden of Non-Specific Low Back Pain, including pain intensity, physical disability, and psychosocial outcomes. The protocol is designed to address methodological gaps in the current literature and to align with international standards for acupuncture clinical trial reporting.