Evaluating blood flow restriction training for knee and shoulder pain relief
Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes
This study is testing if a special type of exercise that restricts blood flow can help people with knee and shoulder pain feel better compared to a fake treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Aspetar Academic / other |
| Locations | 1 site (Doha) |
| Trial ID | NCT04989023 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of low load resistance training combined with blood flow restriction on patients suffering from anterior knee pain and rotator cuff related shoulder pain. It employs a cross-over two-arm randomized design, where participants will receive either blood flow restriction training or a sham treatment. The primary focus is to assess the acute and short-term reduction in pain sensitivity following these interventions, as well as to explore the potential placebo effect. The study aims to provide insights into the mechanisms behind exercise-induced pain relief in musculoskeletal conditions.
Who should consider this trial
Good fit: Ideal candidates are adult males over 18 years with a diagnosis of anterior knee pain lasting more than six weeks.
Not a fit: Patients with a BMI greater than 28 or those with systemic pathologies will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain and improve function in patients with chronic knee and shoulder pain.
How similar studies have performed: Preliminary evidence suggests that blood flow restriction training may be effective, but this specific approach is relatively novel and underexplored.
Eligibility criteria
Show full inclusion / exclusion criteria
Anterior Knee Pain patients We will recruit 40 male adult participants who had consulted a sports medicine physician in a primary care setting for anterior knee pain complaints. A standardized history and physical examination will be conducted by the physiotherapists of the rehabilitation department for inclusion in the study. Inclusion criteria: * age over 18 years, * diagnosis of AKP confirmed by history and physical examination (with or without imaging) for more than six weeks * non-traumatic history of pain onset * pain at least during one of the three functional tests used as outcome measure (single-leg shallow leg squat, single-leg deep knee squat, step down) * pain equal or greater than 3/10 on a numeric pain rating scale (at least in 2/3 functional tests) * unobstructed knee range of motion and no pain in passive end-range knee extension Exclusion criteria: * BMI greater than 28 * systemic pathology including inflammatory joint disease or neoplastic disorders * history of deep venous thrombosis * hypertension (systolic pressure \>140mmHg) * history of endothelial dysfunction * peripheral vascular disease * diabetes * knee pain referred from the spine * history of previous neurological conditions * any previous medical treatment including injections (past 3 months) or drug therapy (i.e., anti-inflammatory drugs the last 2 weeks) * infection * previous blood flow restriction training * inability to understand written and spoken English or Arabic. Rotator cuff related shoulder pain patients We will recruit 40 male adult participants who had consulted a sports medicine physician in a primary care setting for shoulder complaints. A standardized history and physical examination were conducted by the physiotherapists of the rehabilitation department for inclusion in the study. Inclusion criteria: * age over 18 years * rotator cuff related shoulder pain for more than six weeks * pain greater than 3/10 on a numeric pain rating scale on active abduction and/or resisted external rotation at zero degrees of shoulder abduction (assessed in standing with the arm in slight abducted position) Exclusion criteria: * full-thickness rotator cuff tear (positive drop-arm sign and/or radiographic or ultrasonographic evidence) * BMI greater than 28 * previous shoulder surgery or shoulder fracture * imaging evidence of severe shoulder osteoarthritis or tendon calcification,\\ * adhesive capsulitis * systemic pathology including inflammatory joint disease or neoplastic disorders * restriction of passive range of motion in more than two planes * history of deep venous thrombosis * hypertension (systolic pressure \>140mmHg) * history of endothelial dysfunction * peripheral vascular disease * diabetes * shoulder pain referred from the spine * history of previous neurological conditions * any previous medical treatment including injections (past 3 months) or drug therapy (i.e., anti-inflammatory drugs the last 2 weeks) * infection * previous BFR training * inability to understand written and spoken English or Arabic
Where this trial is running
Doha
- Aspetar; Qatar Orthopaedic and Sports Medicine Hospital — Doha, Qatar (Recruiting)
Study contacts
- Principal investigator: Vasileios Korakakis, PhD — Aspetar Orthopedic and Sports Medicine Hospital
- Study coordinator: Vasileios Korakakis, PhD
- Email: Vasileios.Korakakis@aspetar.com
- Phone: +97466672809
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.