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Exercise-Based Strategies for Chronic Back Pain
Condition(s) studied
Chronic Low-back Pain (cLBP)
Investigational drug(s) / intervention(s)
Gym settingsPhysio settingsHome - based settings: exercises based on developmental positionsHome - based settings: Usual activity monitoring
Gym settings: An 8-week supervised full-body resistance training program preceded by a 2-week familiarization phase (4 sessions). During the intervention phase, participants perform training twice weekly for 60 minutes per session. Each session includes a 10-minute warm-up, 40-minute main phase, and 10-minute cool-down. The program consists of 3 sets of 10 repetitions at 75% of 1RM, 90-second rest intervals, and a 3-0-2-1 movement tempo. Training is delivered in a gym setting under professional supervision. Resistance training with or without real-time OHMTRACK biofeedback monitor which support breathing mechanics and trunk stabilization.
Physio settings: An 8-week supervised exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants exercise twice weekly for 60 minutes per session under physiotherapist supervision. Sessions focus on breathing coordination, deep trunk stabilization, postural control, support function, and movement quality using structured developmental movement sequences.
Home - based settings: exercises based on developmental positions: An 8-week home-based exercise program based on developmental positions and neurophysiological principles, preceded by a 2-week familiarization phase (4 sessions). Participants perform exercises twice weekly for 60 minutes per session using electronic manuals and video instructions. The program emphasizes breathing coordination, deep trunk stabilization, postural control, and self-correction of movement quality in an unsupervised home setting, with the possibility of contacting the research team for support.
Home - based settings: Usual activity monitoring: Participants continue their usual daily activities without participating in a structured resistance training or developmental position exercise program. Physical activity is monitored throughout the study using a wearable activity tracker to record daily step counts and overall movement behavior.
Study 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.
Eligibility
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 specifically approved by the study physician.
Primary outcome measure(s)
- Change in Trunk Flexor and Extensor Muscle Function — Baseline, Week 8, Week 12, and Week 16
Trunk Flexor Muscle Strength (Isokinetic Peak Torque): Trunk flexor muscle function will be assessed using an isokinetic dynamometer (Cybex NORM or HUMAC NORM system). The primary outcome will be peak torque during trunk flexion, reported in Newton-meters (N·m) (and, if applicable, normalized to body mass as N·m/kg). Higher values indicate greater trunk flexor strength.
Trunk Extensor Muscle Strength (Isokinetic Peak Torque): Trunk extensor muscle function will be assessed using an isokinetic dynamometer (Cybex NORM or HUMAC NORM system). The primary outcome will be peak torque during trunk extension, reported in N·m (and, if applicable, normalized to body mass as N·m/kg). Higher values indicate greater trunk extensor strength.
- Short-Form McGill Pain Questionnaire (SF-MPQ) Total Score — Baseline to Week 16 (1x every week)
Pain intensity and pain-related characteristics will be assessed using the Short-Form McGill Pain Questionnaire (SF-MPQ). The outcome will be the SF-MPQ total score, calculated as the sum of 15 descriptor items rated on a 0-3 scale (0 = none, 1 = mild, 2 = moderate, 3 = severe). Total score ranges from 0 to 45 points, with higher scores indicating worse pain and lower scores indicating improvement.
- Change in DNS-Based Functional Postural Stabilization Performance — Baseline, Week 8, Week 12, and Week 16
Abdominal wall tension will be measured during the performance of standardized DNS functional tests using a wearable abdominal wall tension monitoring belt (OHMBelt). The device provides continuous, noninvasive, device-derived estimates of abdominal wall tension, which are related to changes in intra-abdominal pressure. Outcomes will include peak abdominal wall tension and mean abdominal wall tension recorded during each DNS test, reported in device-derived units (arbitrary units, a.u.) (and/or as change from baseline, as applicable). Higher values indicate greater abdominal wall tension during task performance.
Trial sites (1)
| Facility | City | Region | Status |
|---|
| Faculty of Physical Education and Sport, Chrales University |
Prague |
Czechia |
|
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