Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes

Patellofemoral Pain Syndrome Clinical Trial

Official title:

Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04989023
• Other study ID #: F202007001
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2021
• Est. completion date: December 2024

Study information

• Verified date: January 2024
• Source: Aspetar
• Contact: Vasileios Korakakis, PhD
• Phone: +97466672809
• Email: Vasileios.Korakakis[@]aspetar.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anterior Knee Pain Syndrome
• Knee Pain Chronic
• Patellofemoral Pain Syndrome
• Rotator Cuff Impingement Syndrome
• Rotator Cuff Injuries
• Rotator Cuff Tendinosis
• Shoulder Impingement Syndrome
• Somatoform Disorders
• Syndrome
• Tendinopathy

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Qatar	Aspetar; Qatar Orthopaedic and Sports Medicine Hospital	Doha

Sponsors (1)

Lead Sponsor	Collaborator
Aspetar

Country where clinical trial is conducted

Qatar, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	Global rating of change scale (GROC) (both knee and shoulder)	Patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (not applicable at baseline)	15 minutes
Secondary	Global rating of change scale (GROC) (both knee and shoulder)	Patient-perceived pain change using a global rating of change scale (GROC) based on a 7-point Likert scale ranging from "Much better - a very important improvement" to "Much worse - an important aggravation" (not applicable at baseline)	1 hour
Secondary	Rating of perceived exertion (RPE) in a modified Borg's scale (Borg CR10)	Participant's rating of perceived exertion (RPE) using a modified Borg's scale (Borg CR10) immediately following the blood flow restriction or sham-blood flow restriction exercise session. The scale has been shown to be an valid alternate tool for estimating the excretion and intensity levels during resistance training. A printed version of the modified scale will be presented to the participants and will be explained that a very hard session would have a rating =7 out of 10 and a rating of 10 meant they were giving maximal effort and could not exert themselves any further. Accordingly, a light session may have a rating of Borg =2, a moderate session may have a rating of Borg >2-<5, and a hard session may have a rating of Borg =5-<7.	15 minutes
Secondary	Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)	Patients will rate their pain during active shoulder abduction (0 to 180°) in standing in a NPRS ranging from 0 to 10	Baseline
Secondary	Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)	Patients will rate their pain during active shoulder abduction (0 to 180°) in standing in a NPRS ranging from 0 to 10	15 minutes
Secondary	Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)	Patients will rate their pain during active shoulder abduction (0 to 180°) in standing in a NPRS ranging from 0 to 10	1 hour