Exercise-Based Strategies for Chronic Back Pain (NCT07475481) | Clinical Trial Compass
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 range
40 Years – 60 Years
Sex
ALL
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Trunk Flexor and Extensor Muscle Function
Timeframe: Baseline, Week 8, Week 12, and Week 16
2
Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score
Timeframe: Baseline to Week 16 (1x every week)
3
Change in DNS-Based Functional Postural Stabilization Performance