Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The study aims to evaluate the effect of low load resistance training combined with blood flow restriction or sham blood flow restriction in patients with anterior knee pain and rotator cuff related shoulder pain in a cross-over two-arm randomized, participant and assessor blinded design. More specifically, we aim to investigate the acute and short-term hypoalgesic response (by evaluating pressure pain detection thresholds) of low load exercise with blood flow restriction or sham blood flow restriction, the effect of these interventions in pain during clinical testing, and the possibility of a placebo effect.

Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

• 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)

Locations
Other Locations
Qatar
Aspetar; Qatar Orthopaedic and Sports Medicine Hospital
RECRUITING
Doha
Contact Information
Primary
Vasileios Korakakis, PhD
Vasileios.Korakakis@aspetar.com
+97466672809
Time Frame
Start Date: 2021-10-01
Estimated Completion Date: 2024-12
Participants
Target number of participants: 80
Treatments
Experimental: Blood flow restriction (BFR) with low load resistance training (knee)
Patients will perform slow open kinetic chain (OKC) knee extension (90°-0°) (2s con, 2s ecc, metronome). A modified pain monitoring will dictate the loading to ≤5 kg with maximum of 4/10 pain. Patients will complete 4 sets (1x30, 3x15 reps) with 30 s rest in between. If the patient fails to shadow the pace of the metronome or to fully extend the knee, the load will be reduced by 0.5Kg. The patients will exercise in sitting with an inflatable cuff of 10cm width and 75cm length will be attached to the most proximal part of the lower extremity. The cuff will remain inflated (80% limb occlusion pressure) throughout the loading session. All participants will undergo a 45-min physiotherapy session, consisting of resistance training (3-4 sets, last set to volitional fatigue), core, and balance exercise. A modified pain monitoring approach will dictate the selection of exercises and the training load (maximum of 4/10 pain).
Sham_comparator: Sham-Blood flow restriction (sham-BFR) with low load resistance training (knee)
Patients will perform slow open kinetic chain (OKC) knee extension (90°-0°) (2s con, 2s ecc, metronome). A modified pain monitoring will dictate the loading to ≤5 kg with maximum of 4/10 pain. Patients will complete 4 sets (1x30, 3x15 reps) with 30 s rest in between. If the patient fails to shadow the pace of the metronome or to fully extend the knee, the load will be reduced by 0.5Kg. The patients will exercise in sitting with an inflatable cuff of 10cm width and 75cm length will be attached to the most proximal part of the lower extremity. The cuff will remain inflated (enough room for two fingers between the skin and the cuff) throughout the loading session. All participants will undergo a 45-min physiotherapy session, consisting of resistance training (3-4 sets, last set to volitional fatigue), core, and balance exercise. A modified pain monitoring approach will dictate the selection of exercises and the training load (maximum of 4/10 pain).
Experimental: Blood flow restriction (BFR) with low load resistance training (shoulder)
Patients will perform slow full range dumbbell biceps curls (2s con, 2s ecc, metronome).Initial load approximately set to 5% of the participants body weight. Patients will complete 4 sets of biceps curls (1x30, 3x15 reps) with 30 s rest between sets.If the patient fails to shadow the pace of the metronome or to fully flex the shoulder, the load will be reduced by 0.5Kg. The patients will exercise in standing with an inflatable cuff of 6cm width and 60cm length will be attached to the most proximal part of the limb. The cuff will remain inflated (60% of the limb complete occlusion pressure) throughout the loading session. All participants will undergo a 45-min physiotherapy session, exercises of the scapula stabilizers, resistance exercises of the rotator cuff muscles (3-4 sets, last set to volitional fatigue), and functional and shoulder proprioception. A modified pain monitoring approach will dictate the selection of exercises and the training load (maximum of 4/10 pain).
Sham_comparator: Sham-Blood flow restriction (sham-BFR) with low load resistance training (shoulder)
Patients will perform slow full range dumbbell biceps curls (2s con, 2s ecc, metronome).Initial load approximately set to 5% of the participants body weight. Patients will complete 4 sets of biceps curls (1x30, 3x15 reps) with 30 s rest between sets.If the patient fails to shadow the pace of the metronome or to fully flex the shoulder, the load will be reduced by 0.5Kg. The patients will exercise in standing with an inflatable cuff of 6cm width and 60cm length will be attached to the most proximal part of the limb. The cuff will remain inflated (enough room for two fingers between the skin and the cuff) throughout the loading session. All participants will undergo a 45-min physiotherapy session, exercises of the scapula stabilizers, resistance exercises of the rotator cuff muscles (3-4 sets, last set to volitional fatigue), and functional and shoulder proprioception. A modified pain monitoring approach will dictate the selection of exercises and the training load (max of 4/10 pain).
Related Therapeutic Areas
Sponsors
Leads: Aspetar

This content was sourced from clinicaltrials.gov