Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes

NCT ID: NCT04989023

Last Updated: 2024-02-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-01
• Study Completion Date: 2024-12-31

Brief 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.

Detailed Description

Exercise-induced hypoalgesia describes an acute reduction in pain sensitivity following exercise.The hypoalgesic response following different types of exercise (aerobic, resistance) has been widely investigated. Preliminary evidence suggests that blood flow restriction training may decrease pain in patients with musculoskeletal conditions. This effect may result from exercise alone, or from blood flow restriction and exercise in combination. However, the possibility that the effects seen are the result of the placebo effect cannot be discounted. The evidence for the hypoalgesic response (improvement in pain perception) following training with blood flow restriction in anterior knee pain, shoulder pain, and general musculoskeletal conditions, as well as the mechanism of blood flow restriction training inducing acute pain reduction, is sparse.Hence, this 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.

Conditions

Knee Pain Chronic; Anterior Knee Pain Syndrome; Patellofemoral Pain Syndrome; Rotator Cuff Impingement Syndrome; Rotator Cuff Tendinosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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).

Group Type: EXPERIMENTAL

Blood flow restriction (BFR) with low load resistance training

Intervention Type: OTHER

Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.

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).

Group Type: SHAM_COMPARATOR

Blood flow restriction (BFR) with low load resistance training

Intervention Type: OTHER

Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.

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).

Group Type: EXPERIMENTAL

Blood flow restriction (BFR) with low load resistance training

Intervention Type: OTHER

Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.

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).

Group Type: SHAM_COMPARATOR

Blood flow restriction (BFR) with low load resistance training

Intervention Type: OTHER

Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.

Interventions

Blood flow restriction (BFR) with low load resistance training

Combination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction.

Intervention Type: OTHER

Other Intervention Names

Sham-Blood flow restriction (sham-BFR) with low load resistance training

Eligibility Criteria

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

• 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

• 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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Aspetar

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Vasileios Korakakis, PhD

Role: PRINCIPAL_INVESTIGATOR

Aspetar Orthopedic and Sports Medicine Hospital

Locations

Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Doha, , Qatar

Site Status: RECRUITING

Countries

Qatar

Central Contacts

Vasileios Korakakis, PhD

Role: CONTACT

Vasileios.Korakakis@aspetar.com

+97466672809

Facility Contacts

Vasileios Korakakis, PhD

Role: primary

Vasileios.Korakakis@aspetar.com

+974 66672809

Rod Whiteley, PhD

Role: backup

Rodney.Whiteley@aspetar.com

+974 66994924

Other Identifiers

F202007001

Identifier Type: -

Identifier Source: org_study_id