Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes

NCT04989023 | Unknown DMC

• 1 other identifier: F202007001
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Blood flow restriction training; Rotator cuff related shoulder pain; Low load resistance training

Outcome Measures

Primary Outcomes (15)

• Pressure pain detection thresholds - PPDTs (knee)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the patient in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the most painful location on the knee (when this will be behind the patella the algometer will be placed on the center of patella), the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly, and the extensor carpi radialis (5cm distal to the lateral epicondyle). The average of the amount of pressure in kilograms of three trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 seconds intervals between assessments.

  Baseline

• Pressure pain detection thresholds - PPDTs (knee)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the patient in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the most painful location on the knee (when this will be behind the patella the algometer will be placed on the center of patella), the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly, and the extensor carpi radialis (5cm distal to the lateral epicondyle). The average of the amount of pressure in kilograms of three trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 seconds intervals between assessments.

  15 minutes

• Pressure pain detection thresholds - PPDTs (knee)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the patient in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the most painful location on the knee (when this will be behind the patella the algometer will be placed on the center of patella), the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly, and the extensor carpi radialis (5cm distal to the lateral epicondyle). The average of the amount of pressure in kilograms of three trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 seconds intervals between assessments.

  1 hour

• Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)

  Three standardized tests will be used in the study to assess anterior knee pain: a) Single-leg squat (shallow): the patient will be standing near a treatment bed with the height of the bed adjusted to be the mid-point of his thigh (halfway between the greater trochanter and popliteal crease), b) Single-leg squat (deep): the patient will be standing near a treatment bed and the height of the bed will be adjusted to the popliteal crease. The patient will be required to touch but not sit on the surface of the bed, and c) Step-down test: the patient will step down from a 20 cm high step using his injured limb in a slow and controlled manner, touching the ground, and returning to the starting position. Immediately after each test the patient will be asked to rate their pain on an 11-point numeric rating scale (NPRS) (0-10)

  Baseline

• Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)

  Three standardized tests will be used in the study to assess anterior knee pain: a) Single-leg squat (shallow): the patient will be standing near a treatment bed with the height of the bed adjusted to be the mid-point of his thigh (halfway between the greater trochanter and popliteal crease), b) Single-leg squat (deep): the patient will be standing near a treatment bed and the height of the bed will be adjusted to the popliteal crease. The patient will be required to touch but not sit on the surface of the bed, and c) Step-down test: the patient will step down from a 20 cm high step using his injured limb in a slow and controlled manner, touching the ground, and returning to the starting position. Immediately after each test the patient will be asked to rate their pain on an 11-point numeric rating scale (NPRS) (0-10)

  15 minutes

• Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)

  Three standardized tests will be used in the study to assess anterior knee pain: a) Single-leg squat (shallow): the patient will be standing near a treatment bed with the height of the bed adjusted to be the mid-point of his thigh (halfway between the greater trochanter and popliteal crease), b) Single-leg squat (deep): the patient will be standing near a treatment bed and the height of the bed will be adjusted to the popliteal crease. The patient will be required to touch but not sit on the surface of the bed, and c) Step-down test: the patient will step down from a 20 cm high step using his injured limb in a slow and controlled manner, touching the ground, and returning to the starting position. Immediately after each test the patient will be asked to rate their pain on an 11-point numeric rating scale (NPRS) (0-10)

  1 hour

• Pressure pain detection thresholds - PPDTs (shoulder)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the participants in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the middle deltoid (muscle belly close to inferolateral insertion), the first interosseous muscle of the hand, and the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly). The average of the amount of pressure in kgs of 3 trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 secs intervals between assessments.

  Baseline

• Pressure pain detection thresholds - PPDTs (shoulder)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the participants in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the middle deltoid (muscle belly close to inferolateral insertion), the first interosseous muscle of the hand, and the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly). The average of the amount of pressure in kgs of 3 trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 secs intervals between assessments.

  15 minutes

• Pressure pain detection thresholds - PPDTs (shoulder)

  Assessed using a hand-held mechanical pressure algometer (Wagner Instruments) with a 1cm2 rubber disk attached to the pressure gauge by applying the probe perpendicularly to the skin at a pressure rate increase of approximately 1kgf/sec. One assessor blinded to group allocation will obtain measurements with the participants in long sitting with both arms resting on the plinth. PPDTs assessment sites will be marked and evaluated over the middle deltoid (muscle belly close to inferolateral insertion), the first interosseous muscle of the hand, and the tibialis anterior (halfway between the most superior attachment to the tibia and its tendon in the upper one third of the muscle belly). The average of the amount of pressure in kgs of 3 trials will be used in the data analysis. The order of PPDTs assessment will be randomized among patients with 30 secs intervals between assessments.

  1 hour

• Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The participants will rate their maximum pain in an 11-point numeric rating scale.

  Baseline

• Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The participants will rate their maximum pain in an 11-point numeric rating scale.

  15 minutes

• Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The participants will rate their maximum pain in an 11-point numeric rating scale.

  1 hour

• Strength in isometric shoulder external rotation (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The maximum of the three trials will be used for analyses.

  Baseline

• Strength in isometric shoulder external rotation (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The maximum of the three trials will be used for analyses.

  15 minutes

• Strength in isometric shoulder external rotation (shoulder)

  The isometric test will be performed in a standardized standing position with feet shoulder width apart, hips and knees in slight flexion, elbow flexed to 90°, and wrist in neutral with the palm facing the midline. The test will be performed as a "make" test and will be repeated three times in a standardized sequence with a 10-second rest between repetitions. Participants before testing will practice two sub-maximal efforts to familiarize themselves with the task. Subsequently, they will be asked to build their force gradually to a maximum voluntary effort over a 5 second period, cued by the examiner with a monotonous voice "push…push…push…push…push…relax" to ensure consistent encouragement. The examiner will keep the dynamometer in place such that the transducer head will be aligned just proximal to the ulnar styloid process, matching the force exerted by the subject. The maximum of the three trials will be used for analyses.

  1 hour

Secondary Outcomes (6)

• Global rating of change scale (GROC) (both knee and shoulder)

  15 minutes

• Global rating of change scale (GROC) (both knee and shoulder)

  1 hour

• Rating of perceived exertion (RPE) in a modified Borg's scale (Borg CR10)

  15 minutes

• Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)

  Baseline

• Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)

  15 minutes

Study Arms (4)

Blood flow restriction (BFR) with low load resistance training (knee)

EXPERIMENTAL

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).

Other: Blood flow restriction (BFR) with low load resistance training

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

SHAM COMPARATOR

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).

Other: Blood flow restriction (BFR) with low load resistance training

Blood flow restriction (BFR) with low load resistance training (shoulder)

EXPERIMENTAL

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).

Other: Blood flow restriction (BFR) with low load resistance training

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

SHAM COMPARATOR

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).

Other: Blood flow restriction (BFR) with low load resistance training

Interventions

Blood flow restriction (BFR) with low load resistance training 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.

Also known as: Sham-Blood flow restriction (sham-BFR) with low load resistance training

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

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• age over 18 years
• rotator cuff related shoulder pain for more than six weeks

Sponsors & Collaborators

• Aspetar: lead

Study Sites (1)

Aspetar; Qatar Orthopaedic and Sports Medicine Hospital

Doha, 29222, Qatar

RECRUITING

MeSH Terms

Conditions

Patellofemoral Pain Syndrome; Shoulder Impingement Syndrome; Rotator Cuff Injuries

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Wounds and Injuries; Rupture; Tendon Injuries

Study Officials

• Vasileios Korakakis, PhD

  Aspetar Orthopedic and Sports Medicine Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vasileios Korakakis, PhD

CONTACT

+97466672809; Vasileios.Korakakis@aspetar.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Outcome assessment at baseline and at all follow-up sequence will be conducted by physiotherapists blinded to the group allocation and previous evaluation data of the patient. Participants will blinded to the sham-blood flow restriction application. They will informed that two different percentages of complete occlusion will be evaluated in terms of their effect in pain following low load exercise loading with blood flow restriction.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2021
• First Posted: August 4, 2021
• Study Start: October 1, 2021
• Primary Completion: December 1, 2024
• Study Completion: December 1, 2024
• Last Updated: February 1, 2024

Record last verified: 2024-01

Locations

QA (1)