None listed
Conditions
Brief summary
This study will evaluate the effectiveness of different dose–response regimens of shockwave therapy in adults with chronic non-specific low back pain. Participants will receive shockwave therapy or conventional physiotherapy aimed at improving pain, mobility, disability, and quality of life. The study is designed to compare outcomes across different treatment approaches over a defined intervention period. Ethical approval for this research has been granted by the PAF Hospital Ethical Research Committee, Islamabad (Application No. 260312, dated 12/03/2026). The study hypothesizes that shockwave therapy will be more effective than conventional care in improving pain and functional outcomes in this population.
Interventions
Dose–Response Extracorporeal Shockwave Therapy (ESWT) Program for Chronic Non-Specific Low Back Pain
This study is a four-arm, assessor-blinded randomized controlled trial comparing three frequency parameters of radial Extracorporeal Shockwave Therapy (rESWT) with conventional physiotherapy in adults with Chronic Non-Specific Low Back Pain (CNSLBP).
Arm 1: Low-Frequency ESWT (5 Hz)
Materials and Procedure:
Shockwave therapy will be administered using a Radial Extracorporeal Shockwave Therapy
Dose–Response Extracorporeal Shockwave Therapy (ESWT) Program for Chronic Non-Specific Low Back Pain This study is a four-arm, assessor-blinded randomized controlled trial comparing three frequency parameters of radial Extracorporeal Shockwave Therapy (rESWT) with conventional physiotherapy in adults with Chronic Non-Specific Low Back Pain (CNSLBP). Arm 1: Low-Frequency ESWT (5 Hz) Materials and Procedure: Shockwave therapy will be administered using a Radial Extracorporeal Shockwave Therapy (rESWT) device. Prior to treatment, standard ultrasound transmission gel will be applied to the lumbar paraspinal region (L3–S1) to ensure effective transmission of shockwaves. The therapy will target painful and tender areas identified during assessment by using slow circular and longitudinal application over affected tissues. A standardized treatment protocol checklist will be followed during each session to maintain consistency, and all treatment details will be documented using session recording log sheets. The intervention will be delivered face-to-face in individual sessions by a licensed physiotherapist with a minimum of five years of musculoskeletal clinical experience and certified training in Extracorporeal Shockwave Therapy (ESWT). Frequency: 5 Hz Impulses: 2000 shocks per session Energy intensity will be titrated to participant tolerance within predefined therapeutic limits. Dose & Schedule: 2 sessions per week 4 weeks duration Total 8 sessions Each session: 15–20 minutes Location Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting) Arm 2: Medium-Frequency ESWT (10 Hz) All procedures identical to Arm 1 except: Frequency: 10 Hz Impulses: 2000 shocks per session Energy intensity will be titrated to participant tolerance within predefined therapeutic limits. Dose & Schedule: 2 sessions per week 4 weeks duration Total 8 sessions Each session: 15–20 minutes Location Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting) Arm 3: High-Frequency ESWT (15 Hz) All procedures identical to Arm 1 except: Frequency: 15 Hz Impulses: 2000 shocks per session Energy intensity will be titrated to participant tolerance within predefined therapeutic limits. Dose & Schedule: 2 sessions per week 4 weeks duration Total 8 sessions Each session: 15–20 minutes Location Physiotherapy Department, Pakistan Air Force (PAF) Hospital (outpatient setting) 2: Strategies used to assess and monitor adherence and fidelity to the intervention will include: Use of a standardized treatment protocol checklist to ensure all treatment procedures are delivered consistently across participants and sessions. Maintenance of session recording log sheets documenting treatment parameters, session duration, attendance, and any deviations from the protocol. Direct observation or periodic supervision of treatment sessions by a senior physiotherapist or research supervisor to confirm protocol compliance. Monitoring participant attendance and completion of all scheduled sessions to assess adherence to the intervention schedule. Training and certification of the treating physiotherapist to maintain standardized intervention delivery.
Sponsors
LINCOLN UNIVERSITY COLLEGE, MALAYSIA
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
a) Adults aged 18–60 years b) Physician Diagnosis of CNSLBP (More than 3 months) c) The pain is typically located in the area between the costal margins (ribs) and the gluteal folds. a. Symptoms and Signs: The primary symptom is low back pain (LBP). This may be included with or without referred leg pain (e.g., pain above the knee), as long as it does not meet the criteria for a specific pathology like radiculopathy. d) Visual Analogue Scale (VAS) pain score equal or more than 3/10 e) Oswestry Disability Index (ODI) equal or more than 30 % f) Able to follow instructions and complete questionnaires
Exclusion criteria
a) Specific LBP causes: disc herniation, spinal stenosis, spondylolisthesis, ankylosing spondylitis, tumors, fractures, infections b) Neurological deficits c) Pregnancy d) Contraindications to shockwave therapy (anticoagulant therapy, metal implants in region, coagulation disorders, severe osteoporosis) e) Severe psychological conditions that might confound the pain or treatment response MINI Cog (e.g., severe depression, active substance abuse).
Outcome results
None listed