Adhesive CapsulitisNCT06019780
Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis
A study testing blood flow restriction trainin and exercise in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this research is to determine the effect of blood flow restriction training on shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The sample size is 36. Read more about this study
- Who is it for?
- Ages 40 to 60 years
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- blood flow restriction trainin and exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Sep 2023to 25 Feb 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 40 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Frozen shoulder (stage 2 and 3 of Kisner and Colby's classification system)
- Male and female
- Patients whose age lies between 40 and 60
- Ranges restriction in forward flexion (scaption) less than 100 degree and reduction of external and internal rotation to less than 50% of the normal
Who cannot join
- • History of Cardiovascular diseases
- DVT patients
- Hypertensive patients
- Patients having neurological disease
- Fracture of humerus
Trial locations and contacts
1 site in 1 country.
About this study
The aim of this research is to determine the effect of blood flow restriction training on shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The sample size is 36. The subjects will be divided in two groups, 18 subjects in BFR group and 18 in no BFR group. Study duration is 6 months. Sampling technique applied was non probability connivance sampling technique. Tools used in the study are SPADI shoulder score, NPRS, hand held dynamometer, sphygmomanometer and goniometer.
Read the detailed description
Frozen shoulder is painful shoulder condition associated with stiffness and shoulder disability. It is associated with reduction in forward elevation and marked external rotation. Frozen shoulder is common condition effecting population between ages 30 to 60 years. Prevalence is more common in women than on men There are four stages of adhesive capsulitis, stage1, stage 2 (freezing stage), stage 3 (frozen stage) and stage 4 (thawing stage). Patient have sharp pain at end range of motion, sleep disturbances and early loss of external rotation. When compared to asymptomatic subjects, patients with adhesive capsulitis have higher upper trapezius to lower trapezius EMG ratios during arm elevation, indicating a muscular imbalance. The scapula eventually migrates upward before 60 degrees of abduction in individuals with adhesive capsulitis, resulting in the recognizable "shrug sign" during shoulder elevation.
Blood flow is restricted in a controlled form of vascular occlusion using external tourniquet. A recent study demonstrated that augmentation of low load resistance with blood flow restriction (L-L BFR) to contractile tissue can produce hypertrophy and strength gains, using loads as low as 30% 1RM. BFR exercise may stimulate skeletal muscle growth and strength gains through a number of different methods. These could include an increase in hormone levels, an increase in the motor pathway or other intracellular signaling pathways for muscle protein synthesis, an increase in satellite cell activity biomarkers, and apparent patterns in fibre type recruitment.
The purpose of this study is to provide the effects of blood flow restriction training on shoulder discomfort, range of motion, muscle strength and disability in patients with adhesive capsulitis. Due to pain and decrease range of motion individual with adhesive capsulitis experience muscle weakness in shoulder joint. Blood flow restriction training has positive effect on improvement of muscle strength and range of motion in shoulder region. Blood flow restriction training has also positive effect on bone healing and bone density. Therefore the study is aimed to improve the muscles strength and capsule inflammation in individual with adhesive capsulitis.
- Conditions
- Adhesive Capsulitis
- Being tested
- blood flow restriction trainin, exercise
- Keywords
- Adhesive capsulitis, Blood flow restriction training, Range of motion
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood flow restriction traininOther
Following exercise will be performed
- Side lying external rotation
- Prone horizontal abduction
- Standing scaption İndividual in the group will be having two session per week, 16 session of exercise training for 8 weeks.50% of arterial occlusion pressure (60 to 80 mmHg) will be applied for total duration of 15mins. Occlusion pressure will be calculated according to formula for each patient [Pressure=0.4x(systolic BP)+2.7x(shoulder circumference)+62].4 sets with one set of 30 repetition and three sets of 15 repetition. After each set subject will have 30 seconds of rest with cuff inflated.
exerciseOther
Following exercises will be performed without application of pneumatic cuff
- Side lying external rotation
- Prone horizontal abduction
- Standing scaption Conventional treatment will include: Hot pack 5 mins Maitland grade 3 and 4 mobilization: inferior glide (10reps x3sets), posterior glide (10reps x 3sets), anterior glide (10 reps x 3sets) Home plan: wand exercise, pendulum exercise, wall walking exercise (10reps x 2sets each)
| Study group | Role | What they receive |
|---|---|---|
| Experimental interventional group A (Blood flow restriction training) | Experimental | Following exercise will be performed
1. Side lying external rotation
2. Prone horizontal abduction
3. Standing scaption with pneumatic cuff for blood flow restriction Receives: Other: blood flow restriction trainin |
| Control group B | Active comparator | Following exercise will be performed
1. Side lying external rotation
2. Prone horizontal abduction
3. Standing scaption without blood flow restriction Receives: Other: exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder apin
the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.
Measured: baseline to 4th to 8 weeks
Shoulder flexors strength
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.
Measured: baseline to 8 weeks
Shoulder extensors strength
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.
Measured: baseline to 8 weeks
Shoulder abductors strength
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.
Measured: baseline to 8 weeks
Shoulder rotation strength
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.
Measured: baseline to 8 weeks
Shoulder disability (SPADI)
measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
Measured: baseline to 8 weeks
Secondary outcomes (6)
shoulder flexion
measures the shoulder flexion range of motion through goniometry
Measured: baseline to 8 weeks
Shoulder extension
measures the shoulder extension range of motion through goniometry
Measured: baseline to 8 weeks
shoulder abduction
measures the shoulder abduction range of motion through goniometry
Measured: baseline to 8 weeks
shoulder adduction
measures the shoulder adduction range of motion through goniometry
Measured: baseline to 8 weeks
shoulder internal rotation
measures the shoulder internal rotation range of motion through goniometry
Measured: baseline to 8 weeks
shoulder external rotation
measures the shoulder external rotation range of motion through goniometry
Measured: baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Aug 2023
- Study start1 Sep 2023
- Primary completion30 Jan 2024
- Study completion25 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aisha Razzaq, MSPT-OMPT, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06019780
- Sponsor's protocol ID
- RiphahIU Hina Yasmeen
- Status last verified
- May 2024
- First submitted
- 26 Aug 2023
- Last updated
- 21 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Blood Flow Restriction Training in Patients With Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT06019780
- Acronym / sponsor ID
- RiphahIU Hina Yasmeen
- Conditions
- Adhesive Capsulitis
- Keywords
- Adhesive capsulitis, Blood flow restriction training, Range of motion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Jan 2024 (actual)
- Study completion
- 25 Feb 2024 (actual)
- First posted
- 31 Aug 2023 (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 aim of this research is to determine the effect of blood flow restriction training on shoulder pain, range of motion, muscle strength and shoulder. Randomized controlled trials will be done at Lady Reading Hospital Peshawar and Shahab Orthopedic General Hospital. The sample size is 36. The subjects will be divided in two groups, 18 subjects in BFR group and 18 in no BFR group. Study duration is 6 months. Sampling technique applied was non probability connivance sampling technique. Tools used in the study are SPADI shoulder score, NPRS, hand held dynamometer, sphygmomanometer and goniometer.
Detailed description
Frozen shoulder is painful shoulder condition associated with stiffness and shoulder disability. It is associated with reduction in forward elevation and marked external rotation. Frozen shoulder is common condition effecting population between ages 30 to 60 years. Prevalence is more common in women than on men There are four stages of adhesive capsulitis, stage1, stage 2 (freezing stage), stage 3 (frozen stage) and stage 4 (thawing stage). Patient have sharp pain at end range of motion, sleep disturbances and early loss of external rotation. When compared to asymptomatic subjects, patients with adhesive capsulitis have higher upper trapezius to lower trapezius EMG ratios during arm elevation, indicating a muscular imbalance. The scapula eventually migrates upward before 60 degrees of abduction in individuals with adhesive capsulitis, resulting in the recognizable "shrug sign" during shoulder elevation.
Blood flow is restricted in a controlled form of vascular occlusion using external tourniquet. A recent study demonstrated that augmentation of low load resistance with blood flow restriction (L-L BFR) to contractile tissue can produce hypertrophy and strength gains, using loads as low as 30% 1RM. BFR exercise may stimulate skeletal muscle growth and strength gains through a number of different methods. These could include an increase in hormone levels, an increase in the motor pathway or other intracellular signaling pathways for muscle protein synthesis, an increase in satellite cell activity biomarkers, and apparent patterns in fibre type recruitment.
The purpose of this study is to provide the effects of blood flow restriction training on shoulder discomfort, range of motion, muscle strength and disability in patients with adhesive capsulitis. Due to pain and decrease range of motion individual with adhesive capsulitis experience muscle weakness in shoulder joint. Blood flow restriction training has positive effect on improvement of muscle strength and range of motion in shoulder region. Blood flow restriction training has also positive effect on bone healing and bone density. Therefore the study is aimed to improve the muscles strength and capsule inflammation in individual with adhesive capsulitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental interventional group A (Blood flow restriction training) | Experimental | Other: blood flow restriction traininFollowing exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption with pneumatic cuff for blood flow restriction |
| Control group B | Active comparator | Other: exerciseFollowing exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption without blood flow restriction |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Frozen shoulder (stage 2 and 3 of Kisner and Colby's classification system)
- Male and female
- Patients whose age lies between 40 and 60
- Ranges restriction in forward flexion (scaption) less than 100 degree and reduction of external and internal rotation to less than 50% of the normal
Key exclusion criteria (5 listed)
- • History of Cardiovascular diseases
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 traininFollowing exercise will be performed 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption İndividual in the group will be having two session per week, 16 session of exercise training for 8 weeks.50% of arterial occlusion pressure (60 to 80 mmHg) will be applied for total duration of 15mins. Occlusion pressure will be calculated according to formula for each patient [Pressure=0.4x(systolic BP)+2.7x(shoulder circumference)+62].4 sets with one set of 30 repetition and three sets of 15 repetition. After each set subject will have 30 seconds of rest with cuff inflated. | Other | Experimental interventional group A (Blood flow restriction training) |
| exerciseFollowing exercises will be performed without application of pneumatic cuff 1. Side lying external rotation 2. Prone horizontal abduction 3. Standing scaption Conventional treatment will include: Hot pack 5 mins Maitland grade 3 and 4 mobilization: inferior glide (10reps x3sets), posterior glide (10reps x 3sets), anterior glide (10 reps x 3sets) Home plan: wand exercise, pendulum exercise, wall walking exercise (10reps x 2sets each) | Other | Control group B |
Primary outcome
shoulder apin
Time frame: baseline to 4th to 8 weeks
the shoulder pain will be measured by NPRS, it has 11 points with 0 no pain and 10 extreme pain.
Shoulder flexors strength
Time frame: baseline to 8 weeks
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply flexion force against isometric resistance.
Shoulder extensors strength
Time frame: baseline to 8 weeks
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply extension force against isometric resistance.
Shoulder abductors strength
Time frame: baseline to 8 weeks
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply abduction force against isometric resistance.
Shoulder rotation strength
Time frame: baseline to 8 weeks
this will be measured by the dynamometer by placing the dynamometer over the muscles and the individual will apply rotation force against isometric resistance.
Shoulder disability (SPADI)
Time frame: baseline to 8 weeks
measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.
6 secondary outcomes
shoulder flexion
Time frame: baseline to 8 weeks
Shoulder extension
Time frame: baseline to 8 weeks
shoulder abduction
Time frame: baseline to 8 weeks
shoulder adduction
Time frame: baseline to 8 weeks
shoulder internal rotation
Time frame: baseline to 8 weeks
shoulder external rotation
Time frame: baseline to 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2024.
- Individual participant dataSharing planned: No
Related trials for Adhesive Capsulitis
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Effects of Clinic Versus mHealth Application-Based Shoulder Rehabilitation in Patients With Adhesive Capsulitis
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Effect of Hormone Replacement Therapy on Physiotherapy Outcomes in Postmenopausal Women With Frozen Shoulder
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Effects of Posterior Capsular Stretching With and Without Dynamic Neuromuscular Stabilization Exercises in Frozen Shoulder
Frozen Shoulder
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Spencer vs. Ola Grimsby Techniques With Scapular Motor Training in Idiopathic Adhesive Capsulitis
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Not yet recruitingPhase 4
OMT for Adhesive Capsulitis
Adhesive Capsulitis of the Shoulder, Frozen Shoulder
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.
Aisha Razzaq, MSPT-OMPT principal investigator
Riphah International University
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 trainin and exercise in people with Adhesive Capsulitis, run by Riphah International University at 1 site in Pakistan.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 21 May 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 Pakistan. 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. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder apin (time frame: baseline to 4th to 8 weeks). The study lists 6 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 21 May 2024.