Shoulder ImpingementNCT05064033
Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies
A study testing Pragmatic Set of intervention and posterior capsular stretch and Pragmatic Set of intervention and Sleeper Stretch in people with Shoulder Impingement and Shoulder Arthritis, run by Helping Hand Institute of Rehabilitation Sciences at 1 site in Pakistan.
Trial summary
The glenohumeral joint is an articulation between the glenoid of the scapula and the head of the humerus that is enclosed by a synovial capsule divided into three main components: anterior, posterior, and the axillary pouch. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Shoulder Impingement, Shoulder Arthritis, Shoulder Injuries
- What is being tested?
- Pragmatic Set of intervention and posterior capsular stretch and Pragmatic Set of intervention and Sleeper Stretch
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 sitePakistan
- Study dates
- 24 May 2021to 24 Mar 2022
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- -Limitation in range of motion abduction or internal rotation or external rotation or reaching up behind the back or reaching behind down the neck are only one of the limitations in comparison with the unaffected joint.
- A patient who fall in grade 1 and grade 2 of the shoulder mobility test of functional movement screening.
Who cannot join
- -Patient with shoulder ligamentous instability Functional movement Screening score 0 or 3. Cancerous growth around the shoulder girdle Rheumatoid arthritis patients The patient has a recent fracture of less than the 6th-week duration or shoulder dislocation.
- Long term use of steroids Cervical joint dysfunction, radicular pain. Systemic diseases.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
HHIRST
Mansehra, Khyber Pakhtunkhwa, 213000
keramat ullah keramat, Ph.D*, +923330927670, karamatjee@yahoo.com
Abdul Haseeb Bhutta, M.phil, +923479470947, abdul.haseeb@hhirs.edu.pk
About this study
Official title: Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies: a Randomized Control Trial (RCT)
The glenohumeral joint is an articulation between the glenoid of the scapula and the head of the humerus that is enclosed by a synovial capsule divided into three main components: anterior, posterior, and the axillary pouch. Symptoms of posterior capsule tightness are linked to altered shoulder biomechanics and impairments which includes glenohumeral internal rotation deficit, incomplete glenohumeral adduction, impaired inferior glenohumeral ligament (IGHL) function, and increased risk of impingement symptoms. In the literature the two techniques available for stretching posterior capsule are pragmatic posterior capsular stretch and sleeper stretch. Pragmatic posterior capsular stretch is therapist administered and sleeper stretch is patient-administered. The work on the pragmatic posterior capsular stretch is more specified and rational to mark the tightness in the posterior capsule.
Read the detailed description
Shoulder pathologies have been reported as the third most popular musculoskeletal problem after knee and back problems and are relatively common in 1 in 3 individuals in their lifetime and reported shoulder pain once a year. The Popular shoulder complex disorders are tendinopathies, rotator cuff lesions, serratus anterior paralysis, subacromial impingement syndrome, and adhesive capsulitis among these 44-65 percent shoulder disorders, contributing to subacromial impingement syndrome.
Posterior capsular tightness is more common in overhead activities which increases the force on shoulder joint which may cause posterior capsular tightness along with rotator cuff tear. The active stabilizer for shoulder is rotator cuff which avoid the superior translation of humeral head during shoulder abduction due to weakness of rotator cuff along with posterior inferior capsular tightness the humeral head may translate superiorly and ultimately lead to SAIS in which rotator cuff tendon long head of biceps and subacromial bursa impinge between acromion superiorly and greater tubercle of humeral head inferiorly. Tears of the subscapularis tendon are mostly the result of a degenerative process, but less commonly, traumatic injury can result in acute subscapularis tearing. The most common mechanisms of subscapularis injury are hyperextension and external rotation of the shoulder.6 The infraspinatus (ISP) muscle, one of the rotator cuff muscles. Pain in the infraspinatus is most likely caused by repetitive motion involving the shoulder. Swimmers, tennis players, painters, and carpenters get it more frequently. It also becomes more likely as you get older.
The serratus anterior play an important role in prevention of shoulder impingement by lifting the acromion process in overhead activities. The most common pathologies of serratus anterior is serratus anterior dysfunction which may cause scapula winging.8 In GHIRD glenohumeral internal rotation deficit there is 18 to 20 degree of limitation along with glenohumeral horizontal adduction and incomplete humeral rotation can lead to posterior capsular tightness. Therefore, posterior capsular stretch is more effective intervention for posterior capsular tightness.AC joint is responsible for shoulder disability and pain in inactive patient and athletic activities including skiing, cycling and mostly in contact sports which contribute 9 percent approximately of AC joint damage with shoulder injuries. Impairment of AC joint effects range of motion, pain and weakness along with poor posture and these leads to restriction in overhead activities.
The most frequent causes are posterior capsular tightness and rotator cuff tear involve overhead movements such as swimming and volleyball and basketball, which have high-velocity pressures on the joint shoulder.
In non-operative management of subacromial impingement, anti-inflammatory mediction,subacromial injection of steriods, ultrasound, lifestyle changes, and physical therapy management is normally given. Physical therapy is used to reduce the pain and enhance the functioning of the SIS. Patients should attempt to discontinue overhead movements unless symptoms diminish.
A pragmatic posterior capsular stretch (PPCS) is designed to stretch the posterior capsule when it is in torsion.Pragmatic Posterior capsular stretch can effectively improve the functional movements and shoulder ROM of healthy young adults.16 Another popular stretch is the "sleeper stretch". There is a significant increase in posterior shoulder flexibility by sleeper stretch.Scapular movement is restricted while performing the sleeper stretch and accomplished by lying on the side to be stretched, elevating the humerus to 90° on the support surface, then passively internally rotating the shoulder with the opposite arm.
- Conditions
- Shoulder Impingement, Shoulder Arthritis, Shoulder Injuries, Shoulder Capsulitis, Shoulder Bursitis, Shoulder Pain Chronic
- Being tested
- Pragmatic Set of intervention and posterior capsular stretch, Pragmatic Set of intervention and Sleeper Stretch
- Keywords
- sleeper stretch, shoulder pathologies, Posterior capsular tightness, shoulder range of motion, pragmatic posterior capsular stretch, pragmatic intervention
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pragmatic Set of intervention and posterior capsular stretchOther
Group 1 will receive a pragmatic set of interventions, including Serratus Anterior Stretch,Rotator Cuff Facilitation,Acromilcalavicular joint Mobilization,Stretch of Pectoralis Major and Minor,Thoracic Manipulation and posterior capsular stretch.
Pragmatic Set of intervention and Sleeper StretchOther
Group 2 will receive a pragmatic set of interventions, including Serratus Anterior Stretch, Rotator Cuff Facilitation, Acromilcalavicular joint Mobilization, Stretch of Pectoralis Major and Minor, Thoracic Manipulation and sleeper stretch.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | Experimental | Pragmatic Set of intervention and posterior capsular stretch Receives: Other: Pragmatic Set of intervention and posterior capsular stretch |
| GROUP B | Active comparator | Pragmatic Set of intervention and Sleeper Stretch Receives: Other: Pragmatic Set of intervention and Sleeper Stretch |
What is being measured
The primary outcome is the main question the study is designed to answer.
shoulder range of motion
shoulder range of motion will be measured in degrees by using digital inclinometer
Measured: 6 weeks
shoulder pain
shoulder pain will be measured by numeric pain rating scale
Measured: 6 weeks
Secondary outcomes (3)
Shoulder related quality of life
quality of life will be measured by using HHIRS quality of life questionnaire
Measured: 6 weeks
Shoulder disability
Shoulder disability will be measured by Shoulder Pain And Disability Index Urdu (SPADI-U)
Measured: 6 weeks
satisfaction level of patient
satisfaction level of patient will be measured by Questionnaire for satisfaction level of patient receving this intervention
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2021
- Study start24 May 2021
- Primary completion24 Dec 2021 (estimated)
- Study completion24 Mar 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Shoulder ImpingementStudies 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
- Parallel groups
- Model description
- Randomized control trial(double-blind)
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Helping Hand Institute of Rehabilitation Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Keramat Ullah, Helping Hand Institute of Rehabilitation Sciences
- Investigators
- keramat ullah karamat, Ph.D.*, Principal investigator, HHIRST
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05064033
- Sponsor's protocol ID
- Rec.letter/st./2021/20/03/04
- Status last verified
- Sep 2021
- First submitted
- 29 Sep 2021
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As per the decision of the research ethics committee.
Publications
Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol). 2003 Jun;18(5):369-79. doi: 10.1016/s0268-0033(03)00047-0.
PubMed 12763431Umer M, Qadir I, Azam M. Subacromial impingement syndrome. Orthop Rev (Pavia). 2012 May 9;4(2):e18. doi: 10.4081/or.2012.e18. Epub 2012 May 31.
PubMed 22802986Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.
PubMed 26537804Lyons RP, Green A. Subscapularis tendon tears. J Am Acad Orthop Surg. 2005 Sep;13(5):353-63. doi: 10.5435/00124635-200509000-00009.
PubMed 16148361Johnson JE, Fullmer JA, Nielsen CM, Johnson JK, Moorman CT 3rd. Glenohumeral Internal Rotation Deficit and Injuries: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2018 May 22;6(5):2325967118773322. doi: 10.1177/2325967118773322. eCollection 2018 May.
PubMed 29845083Keramat KU, Naveed Babur M. Pragmatic posterior capsular stretch and its effects on shoulder joint range of motion. BMJ Open Sport Exerc Med. 2020 Sep 9;6(1):e000805. doi: 10.1136/bmjsem-2020-000805. eCollection 2020.
PubMed 33062302Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.
PubMed 18668168
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Posterior Capsular Stretch Versus Sleeper Stretch in Subject With Shoulder Pathologies: a Randomized Control Trial (RCT)
- ClinicalTrials.gov ID
- NCT05064033
- Acronym / sponsor ID
- Rec.letter/st./2021/20/03/04
- Conditions
- Shoulder Impingement, Shoulder Arthritis, Shoulder Injuries, Shoulder Capsulitis, Shoulder Bursitis, Shoulder Pain Chronic
- Keywords
- sleeper stretch, shoulder pathologies, Posterior capsular tightness, shoulder range of motion, pragmatic posterior capsular stretch, pragmatic intervention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Helping Hand Institute of Rehabilitation SciencesUniversity, hospital or other
- Study start
- 24 May 2021 (actual)
- Primary completion
- 24 Dec 2021 (estimated)
- Study completion
- 24 Mar 2022 (estimated)
- First posted
- 1 Oct 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 glenohumeral joint is an articulation between the glenoid of the scapula and the head of the humerus that is enclosed by a synovial capsule divided into three main components: anterior, posterior, and the axillary pouch. Symptoms of posterior capsule tightness are linked to altered shoulder biomechanics and impairments which includes glenohumeral internal rotation deficit, incomplete glenohumeral adduction, impaired inferior glenohumeral ligament (IGHL) function, and increased risk of impingement symptoms. In the literature the two techniques available for stretching posterior capsule are pragmatic posterior capsular stretch and sleeper stretch. Pragmatic posterior capsular stretch is therapist administered and sleeper stretch is patient-administered. The work on the pragmatic posterior capsular stretch is more specified and rational to mark the tightness in the posterior capsule.
Detailed description
Shoulder pathologies have been reported as the third most popular musculoskeletal problem after knee and back problems and are relatively common in 1 in 3 individuals in their lifetime and reported shoulder pain once a year. The Popular shoulder complex disorders are tendinopathies, rotator cuff lesions, serratus anterior paralysis, subacromial impingement syndrome, and adhesive capsulitis among these 44-65 percent shoulder disorders, contributing to subacromial impingement syndrome.
Posterior capsular tightness is more common in overhead activities which increases the force on shoulder joint which may cause posterior capsular tightness along with rotator cuff tear. The active stabilizer for shoulder is rotator cuff which avoid the superior translation of humeral head during shoulder abduction due to weakness of rotator cuff along with posterior inferior capsular tightness the humeral head may translate superiorly and ultimately lead to SAIS in which rotator cuff tendon long head of biceps and subacromial bursa impinge between acromion superiorly and greater tubercle of humeral head inferiorly. Tears of the subscapularis tendon are mostly the result of a degenerative process, but less commonly, traumatic injury can result in acute subscapularis tearing. The most common mechanisms of subscapularis injury are hyperextension and external rotation of the shoulder.6 The infraspinatus (ISP) muscle, one of the rotator cuff muscles. Pain in the infraspinatus is most likely caused by repetitive motion involving the shoulder. Swimmers, tennis players, painters, and carpenters get it more frequently. It also becomes more likely as you get older.
The serratus anterior play an important role in prevention of shoulder impingement by lifting the acromion process in overhead activities. The most common pathologies of serratus anterior is serratus anterior dysfunction which may cause scapula winging.8 In GHIRD glenohumeral internal rotation deficit there is 18 to 20 degree of limitation along with glenohumeral horizontal adduction and incomplete humeral rotation can lead to posterior capsular tightness. Therefore, posterior capsular stretch is more effective intervention for posterior capsular tightness.AC joint is responsible for shoulder disability and pain in inactive patient and athletic activities including skiing, cycling and mostly in contact sports which contribute 9 percent approximately of AC joint damage with shoulder injuries. Impairment of AC joint effects range of motion, pain and weakness along with poor posture and these leads to restriction in overhead activities.
The most frequent causes are posterior capsular tightness and rotator cuff tear involve overhead movements such as swimming and volleyball and basketball, which have high-velocity pressures on the joint shoulder.
In non-operative management of subacromial impingement, anti-inflammatory mediction,subacromial injection of steriods, ultrasound, lifestyle changes, and physical therapy management is normally given. Physical therapy is used to reduce the pain and enhance the functioning of the SIS. Patients should attempt to discontinue overhead movements unless symptoms diminish.
A pragmatic posterior capsular stretch (PPCS) is designed to stretch the posterior capsule when it is in torsion.Pragmatic Posterior capsular stretch can effectively improve the functional movements and shoulder ROM of healthy young adults.16 Another popular stretch is the "sleeper stretch". There is a significant increase in posterior shoulder flexibility by sleeper stretch.Scapular movement is restricted while performing the sleeper stretch and accomplished by lying on the side to be stretched, elevating the humerus to 90° on the support surface, then passively internally rotating the shoulder with the opposite arm.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial(double-blind)
| Arm | Type | Receives |
|---|---|---|
| GROUP A | Experimental | Other: Pragmatic Set of intervention and posterior capsular stretchPragmatic Set of intervention and posterior capsular stretch |
| GROUP B | Active comparator | Other: Pragmatic Set of intervention and Sleeper StretchPragmatic Set of intervention and Sleeper Stretch |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- -Limitation in range of motion abduction or internal rotation or external rotation or reaching up behind the back or reaching behind down the neck are only one of the limitations in comparison with the unaffected joint.
- A patient who fall in grade 1 and grade 2 of the shoulder mobility test of functional movement screening.
Key exclusion criteria (2 listed)
- -Patient with shoulder ligamentous instability Functional movement Screening score 0 or 3. Cancerous growth around the shoulder girdle Rheumatoid arthritis patients The patient has a recent fracture of less than the 6th-week duration or shoulder dislocation.
- Long term use of steroids Cervical joint dysfunction, radicular pain. Systemic 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 |
|---|---|---|
| Pragmatic Set of intervention and posterior capsular stretchGroup 1 will receive a pragmatic set of interventions, including Serratus Anterior Stretch,Rotator Cuff Facilitation,Acromilcalavicular joint Mobilization,Stretch of Pectoralis Major and Minor,Thoracic Manipulation and posterior capsular stretch. | Other | GROUP A |
| Pragmatic Set of intervention and Sleeper StretchGroup 2 will receive a pragmatic set of interventions, including Serratus Anterior Stretch, Rotator Cuff Facilitation, Acromilcalavicular joint Mobilization, Stretch of Pectoralis Major and Minor, Thoracic Manipulation and sleeper stretch. | Other | GROUP B |
Primary outcome
shoulder range of motion
Time frame: 6 weeks
shoulder range of motion will be measured in degrees by using digital inclinometer
shoulder pain
Time frame: 6 weeks
shoulder pain will be measured by numeric pain rating scale
3 secondary outcomes
Shoulder related quality of life
Time frame: 6 weeks
Shoulder disability
Time frame: 6 weeks
satisfaction level of patient
Time frame: 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Background: PubMed 12763431Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol). 2003 Jun;18(5):369-79. doi: 10.1016/s0268-0033(03)00047-0.
- Background: PubMed 22802986Umer M, Qadir I, Azam M. Subacromial impingement syndrome. Orthop Rev (Pavia). 2012 May 9;4(2):e18. doi: 10.4081/or.2012.e18. Epub 2012 May 31.
- Background: PubMed 26537804Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.
- Background: PubMed 16148361Lyons RP, Green A. Subscapularis tendon tears. J Am Acad Orthop Surg. 2005 Sep;13(5):353-63. doi: 10.5435/00124635-200509000-00009.
- Background: PubMed 29845083Johnson JE, Fullmer JA, Nielsen CM, Johnson JK, Moorman CT 3rd. Glenohumeral Internal Rotation Deficit and Injuries: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2018 May 22;6(5):2325967118773322. doi: 10.1177/2325967118773322. eCollection 2018 May.
- Background: PubMed 33062302Keramat KU, Naveed Babur M. Pragmatic posterior capsular stretch and its effects on shoulder joint range of motion. BMJ Open Sport Exerc Med. 2020 Sep 9;6(1):e000805. doi: 10.1136/bmjsem-2020-000805. eCollection 2020.
- Background: PubMed 18668168Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.
- Individual participant dataSharing planned: No. As per the decision of the research ethics committee.
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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.
keramat ullah karamat, Ph.D.* principal investigator
HHIRST
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pragmatic Set of intervention and posterior capsular stretch and Pragmatic Set of intervention and Sleeper Stretch in people with Shoulder Impingement and Shoulder Arthritis, run by Helping Hand Institute of Rehabilitation Sciences 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 2 inclusion and 2 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 Oct 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact keramat ullah karamat, Ph.D.* (+923330927670, karamatjee@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
shoulder range of motion (time frame: 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05064033, which also lists 7 linked publications.
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 Oct 2021.