Knee Pain ChronicNCT04989023
Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes
A study testing Blood flow restriction (BFR) with low load resistance training in people with Knee Pain Chronic and Anterior Knee Pain Syndrome, run by Aspetar at 1 site in Qatar.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Knee Pain Chronic, Anterior Knee Pain Syndrome, Patellofemoral Pain Syndrome
- What is being tested?
- Blood flow restriction (BFR) with low load resistance training
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteQatar
- Study dates
- 1 Oct 2021to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Show all 32Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Qatar1 site, 1 recruiting
- Recruiting
Aspetar; Qatar Orthopaedic and Sports Medicine Hospital
Doha, 29222
Vasileios Korakakis, PhD, +974 66672809, Vasileios.Korakakis@aspetar.com
Rod Whiteley, PhD, +974 66994924, Rodney.Whiteley@aspetar.com
About this study
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.
Read the 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
- Being tested
- Blood flow restriction (BFR) with low load resistance training
- Keywords
- Blood flow restriction training, Rotator cuff related shoulder pain, Low load resistance training
- Medical subject headings
- Patellofemoral Pain Syndrome, Shoulder Impingement Syndrome, Rotator Cuff Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood flow restriction (BFR) with low load resistance trainingOther
Also called Sham-Blood flow restriction (sham-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.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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). Receives: 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). Receives: 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). Receives: Other: Blood flow restriction (BFR) with low load resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 hour
Secondary outcomes (6)
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)
Measured: 15 minutes
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)
Measured: 1 hour
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.
Measured: 15 minutes
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
Measured: Baseline
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
Measured: 15 minutes
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
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Oct 2021
- Primary completionDec 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Knee Pain ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aspetar
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Vasileios Korakakis, PhD, Principal investigator, Aspetar Orthopedic and Sports Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04989023
- Sponsor's protocol ID
- F202007001
- Status last verified
- Jan 2024
- First submitted
- 3 Jul 2021
- Last updated
- 1 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Applications of Blood Flow Restriction and Rehabilitation Outcomes
- ClinicalTrials.gov ID
- NCT04989023
- Acronym / sponsor ID
- F202007001
- 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
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- AspetarUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance training (knee) | Experimental | Other: Blood flow restriction (BFR) with low load resistance trainingPatients 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-Blood flow restriction (sham-BFR) with low load resistance training (knee) | Sham comparator | Other: Blood flow restriction (BFR) with low load resistance trainingPatients 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). |
| Blood flow restriction (BFR) with low load resistance training (shoulder) | Experimental | Other: Blood flow restriction (BFR) with low load resistance trainingPatients 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-Blood flow restriction (sham-BFR) with low load resistance training (shoulder) | Sham comparator | Other: Blood flow restriction (BFR) with low load resistance trainingPatients 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). |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (32 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood flow restriction (BFR) with low load resistance trainingAlso: Sham-Blood flow restriction (sham-BFR) with low load resistance trainingCombination of low load resistance exercise in the upper or lower limb with the addition of blood flow restriction or sham-blood flow restriction. | Other | 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) |
Primary outcome
Pressure pain detection thresholds - PPDTs (knee)
Time frame: Baseline
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.
Pressure pain detection thresholds - PPDTs (knee)
Time frame: 15 minutes
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.
Pressure pain detection thresholds - PPDTs (knee)
Time frame: 1 hour
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.
Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)
Time frame: Baseline
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)
Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)
Time frame: 15 minutes
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)
Pain in clinical tests - Numeric Pain Rating Scale (NPRS) (knee)
Time frame: 1 hour
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)
Pressure pain detection thresholds - PPDTs (shoulder)
Time frame: Baseline
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.
Pressure pain detection thresholds - PPDTs (shoulder)
Time frame: 15 minutes
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.
Pressure pain detection thresholds - PPDTs (shoulder)
Time frame: 1 hour
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.
Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: Baseline
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.
Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: 15 minutes
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.
Pain in isometric shoulder external rotation - Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: 1 hour
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.
Strength in isometric shoulder external rotation (shoulder)
Time frame: Baseline
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.
Strength in isometric shoulder external rotation (shoulder)
Time frame: 15 minutes
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.
Strength in isometric shoulder external rotation (shoulder)
Time frame: 1 hour
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.
6 secondary outcomes
Global rating of change scale (GROC) (both knee and shoulder)
Time frame: 15 minutes
Global rating of change scale (GROC) (both knee and shoulder)
Time frame: 1 hour
Rating of perceived exertion (RPE) in a modified Borg's scale (Borg CR10)
Time frame: 15 minutes
Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: Baseline
Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: 15 minutes
Pain during active shoulder abduction (0 to 180°) in standing in a Numeric Pain Rating Scale (NPRS) (shoulder)
Time frame: 1 hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasileios Korakakis, PhD principal investigator
Aspetar Orthopedic and Sports Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood flow restriction (BFR) with low load resistance training in people with Knee Pain Chronic and Anterior Knee Pain Syndrome, run by Aspetar at 1 site in Qatar.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Qatar. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Vasileios Korakakis, PhD (+97466672809, Vasileios.Korakakis@aspetar.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain detection thresholds - PPDTs (knee) (time frame: Baseline). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2024.