Not Yet RecruitingNot Applicable

Exercise-Based Strategies for Chronic Back Pain

Czechia120 participantsStarted 2027-07-01

Plain-language summary

This randomized, controlled, five-arm, parallel-group trial will evaluate the effects of 8 weeks of supervised resistance training and developmental position-based exercise, with or without real-time non-invasive intra-abdominal pressure biofeedback, in adults aged 40 to 60 years with chronic low back pain. The trial will compare supervised gym-based agonist-antagonist paired set resistance training with OHMTRACK, supervised gym-based resistance training without OHMTRACK, supervised physiotherapy-based developmental exercise with OHMTRACK, home-based developmental exercise with OHMTRACK, and an active control condition. Primary outcomes will assess changes in pain and physical function after the intervention. Secondary outcomes will include neuromuscular coordination, postural stabilization, cardiovascular, respiratory, metabolic, behavioral, feasibility, and follow-up outcomes.

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Chronic low back pain lasting more than 12 weeks, with current low back pain at screening/baseline. * Resting blood pressure below 139/89 mmHg. * Health status allowing participation in moderate-intensity resistance training and aerobic activity. * Physically active, but not professional athletes. * Non-smoker. * Able and willing to provide written informed consent and comply with study procedures Exclusion Criteria: * Absolute or relative contraindications to resistance training or other clinically relevant cardiovascular contraindications. * Coronary artery disease, heart rhythm disorders, acute myocarditis, Marfan syndrome, or other cardiovascular conditions judged unsafe by the study physician. * History of myocardial infarction, cerebrovascular disease, peripheral vascular disease, or grade II-IV hypertension. * Type 1 or type 2 diabetes mellitus. * Severe obesity (BMI \>= 40.0 kg/m2). * Infectious disease at screening (for example, COVID-19 or influenza). * Current treatment for chronic low back pain from another healthcare provider. * Prior spine surgery or lower-limb surgery. * Structural spinal deformity such as spondylolisthesis or spondylolysis. * Spinal fracture, inflammatory spinal disorder, or neurological signs of nerve root compromise, including decreased tendon reflexes, sensory loss, or motor deficits. * Dizziness during exercise. * Use of medications other than analgesics and non-steroidal anti-inflammatory drugs, unless specificall…

What they're measuring

Change in Trunk Flexor and Extensor Muscle Function

Timeframe: Baseline, Week 8, Week 12, and Week 16

Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score

Timeframe: Baseline to Week 16 (1x every week)

Change in DNS-Based Functional Postural Stabilization Performance

Timeframe: Baseline, Week 8, Week 12, and Week 16

Trial details

NCT IDNCT07475481

SponsorCharles University, Czech Republic

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-03-31

Contact for this trial

Roman Jurik, Ph.D.

+420 775 218 277 roman.jurik@ftvs.cuni.cz

View on ClinicalTrials.gov More Chronic Low-back Pain (cLBP) trials

Plain-language summary

Who can participate

Age range40 Years – 60 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Change in Trunk Flexor and Extensor Muscle Function

Timeframe: Baseline, Week 8, Week 12, and Week 16

Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score

Timeframe: Baseline to Week 16 (1x every week)

Change in DNS-Based Functional Postural Stabilization Performance

Timeframe: Baseline, Week 8, Week 12, and Week 16