Shoulder ImpingementNCT04242888
The Acute Effects of Pragmatic Manual Therapy on the Range of Motion of Shoulder Joint
A study testing pragmatic manual therapies in people with Shoulder Impingement and Prehabilitation, run by Isra University at 1 site in Pakistan.
Trial summary
Current studies on the mechanism of subacromial impingement and other shoulder pathology reveal that multiple factors are responsible for impingement. These include serratus anterior dysfunction, rotator cuff insufficiency, posterior capsular tightness, acromioclavicular joint, thoracic spine stiffness and… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Impingement, Prehabilitation, Rehabilitation
- What is being tested?
- pragmatic manual therapies
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Apr 2018to 1 Jan 2021
- 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
- Healthy volunteers accepted
- Adult
Who may be able to join
- For trial 1-4
- Limitation in Abduction or Internal rotation or reaching behind up or down the back
- A score of 1 and 2 on FMS For trial 5
- main complaint in gleno-humeral joint
- Limitation in Range of motion of Abduction or internal rotation or external rotation or reaching up behind the back or reaching down behind down the neck , all or only one of the limitation in comparison with the unaffected joint.
Who cannot join
- For trial 1-4
- Any known pathology or deformity of the shoulder joint
- A zero and 3 score on FMS For trial 5
- <!-- -->
- Previous history of dislocation or fracture in shoulder
- Severe underlying chronic medical condition
Show all 13Show fewer
- shoulder surgeries
- Brachial plexus and axillary nerve injuries
- Severe constant shoulder pain which does not fit into the inclusion criteria
- Pain associated with shoulder swelling, redness or cysts
- Known rheumatoid arthritis
- Steroid injection within two weeks
- Psychosocial yellow flags or intellectual disability
Trial locations and contacts
1 site in 1 country.
Pakistan1 site, 1 recruiting
- Recruiting
HHIRS
Mansehra, KPK, 21300
Keramat Ullah, M.Phil, +923330927670, principal@hhirs.edu.pk
Abdul Haseeb Bhutta, M.Phil, +923479470947, abdulhaseeb@hhirs.edu.pk
About this study
Current studies on the mechanism of subacromial impingement and other shoulder pathology reveal that multiple factors are responsible for impingement. These include serratus anterior dysfunction, rotator cuff insufficiency, posterior capsular tightness, acromioclavicular joint, thoracic spine stiffness and extensibility of the pectoralis minor and subclavius muscles. Manual intervention should therefore address these issues in conjunction with the other therapies. Novel interventions have been designed pilot tested for each of these factors to produce a healing environment. The purpose of this study is to evaluate the effects of each individual factor and combination of all on the range of motion of shoulder joint in healthy subjects and subjects with a restricted range of motion of shoulder joint respectively. The subject will be allocated randomly into four groups with respect to objective 1 and each of the groups will be evaluated as a quasi-experiment design (pretest-posttest) for healthy each of 30 subjects. Beneficial intervention among the four trials and other previously reported beneficial in improving the shoulder joint range will be combined in and termed as pragmatic intervention protocols. Pragmatic interventions on subjects with the restricted range in shoulder pathology will be tested through a similar design. The effects of these interventions on the Quality of life measured through the Urdu version of Shoulder pain and disability in subjects with shoulder pathology will also be tested.
Read the detailed description
Shoulder disorders are the 3rd commonest among musculoskeletal conditions. Its prevalence is estimated 7-26% at one point of time and 67% of the individuals experience shoulder pain once in their life. Subacromial impingements (SAIS) are the frequent diagnosis accounting for 45-65% of all shoulder disorders. It is defined as "a condition in which the tendons of the rotator cuff muscles, long head of the biceps or the subacromial bursa are entrapped between the humeral head inferiorly and anterior acromion superiorly.
Multiple researchers have studied interventions which affect the shoulder range of motions. Thoracic spine manipulation improves the shoulder range of motion. Similarly, Stretching the pectorallis minor muscles improve shoulder kinematics. Manual intervention for subscapularis, infra spinatus, and serratus anterior are non-existent to investigators' knowledge. Modification to stretch the posterior capsule in a pragmatic manner is described and recommended but trials are nonexistent. Acromioclavicular joint being the part of the scapolo-glenohumeral complex has a role to play in the kinematics of the shoulder but trials on its mobilization with respect to shoulder range of motion are not been studies. These gaps in research in relation to understanding of the mechanism of shoulder pathology and subsequent intervention are also identified but trials and interventions are non-existent.
The understanding of the complex relations of the intrinsic and extrinsic factors necessitates the development of manual therapy interventions to address the factors which are adversely affect range of motion of shoulder joint. The purpose of this research is to develop and propose manual therapy interventions for shoulder joint which can effectively address the limitations in shoulder joint ranges of motion in both healthy subjects and subjects with shoulder pathology having decrease range of motion through a series of primitive trials.
AIMES AND OBJECTIVES The primary purpose of this study is to evaluate the short term effects of Pragmatic manual interventions on range of motion of the shoulder joint in healthy individual and individuals with shoulder pathology who have restricted ranges of motion .The aims of this study are therefore to
- To evaluate the effects of pragmatic interventions in healthy asymptomatic subjects with respect to the changes in shoulder joint restricted range of motion
- To evaluate the effects of interventions in symptomatic shoulder individual with restriction in their shoulder range of motion and short term change in the shoulder related quality of life and pain MATERIAL AND METHOD A single group quasi-experimental (pretest-posttest) design will be used for all the trials in this study. It will be conducted at Helping Hand Institute of Rehabilitation Sciences, Mansehra. The study will be composed of 4 trials in the first phase on healthy subject with respect to each of the proposed pragmatic (novice) intervention consistent with the first objective and exploratory in nature. Subjects will be randomly allocated to the initial four groups. The initial 4 trials on healthy subjects are chosen since the effects of each of the proposed pragmatic interventions is not been studied but advocated. Healthy subjects with restriction in shoulder ROM are deemed appropriate since other confounding factors such as pain is absent and objectives could be achieved. In Phase 2, trial on patient with shoulder pathology will be conducted after evaluating the effects on range of motion in healthy individual. Each trial will recruit 30 subjects. subjects in trial 5 with shoulder pathology will be assessed through Urdu version of shoulder pain and disability index at baseline, after one week and 5 weeks of pragmatic interventions. A sample size of 30 for each trial ( a total of 150 subject) is deemed appropriate after a pilot trial on 5 healthy subject which produced a meaningful difference of 15 degree change in abduction, and 3 cm difference in reaching up behind the back and using standard deviation estimates from previous studies. Finally, The urdu translated and validated version of SPADI will used to measure shoulder related pain and Disability. Ethical approval will be sought from REC Isra university and Ethical committee of HHIRS. Subjects consent will be taken in writing (annex 2) and full study information will be given (annex 3). Each of Phase 1 and phase 2 of this study will be completed in 6 months (a total of 1 year) from August 2019 to August 2020.
SUBJECTS ASSESSMENT PROCEDURE For healthy subject of the initial 4 trials, subjects willing to participate will be screened against the inclusion and exclusion criteria. Each participant for trial 5 with shoulder pathologies will be assessed thoroughly and screened against the inclusion and exclusion criteria. Demographic information, information related to history of the presenting complaint, past medical and surgical history, hobbies, occupation, drug history and social history will be collected from all the eligible subjects in trial 5. Additional information in relation to date of onset, behavior of symptoms, aggravating, easing factors, previous treatment including injection and other surgical interventions, relevant investigation will be collected.
A detailed objective examination process will be followed for participants in trial 5. Examination process will include inspection of the shoulders, cervical spine and thoracic spine from the front, each side and back. Any abnormality seen will be documented.
Inspection will be followed by ruling out any pathology of the neck by asking the patient to perform active neck rotation to each side, side flexion, extension and flexion and any pain, discomfort and paraesthesia will be noted. These quick movements are assumed sufficient to rule out any pathology of the neck. Neck movements will be followed by the active elevation (flexion and abduction) of the shoulder joint and any pain, restriction in range and willingness to movement will be noted. Active reaching behind the back will be performed and any limitation in comparison with the asymptomatic side noted. Limitation will be measures from the respective posterior superior iliac spine though measuring tape. Active elation of the arm is followed by the passive movements of abduction, flexion, and medial rotation. Any limitation of range, end feel and pain will be noted during each of the passive movement. Active resisted movement of abduction, medial rotation, later rotation of shoulder and flexion and extension of elbow are followed and strength/pain will be noted. The systematic procedure of assessment followed from Cyriax and has been found highly reliable(39) and assessment procedure including similar procedures Special test such as Neer's sign, Hawkin kennedy test, scarf test, speed test, O'brien's test will be administered to determine SAIS.
- Conditions
- Shoulder Impingement, Prehabilitation, Rehabilitation
- Being tested
- pragmatic manual therapies
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pragmatic manual therapiesOther
Also called Rotator cuff facilitation, Serratus anterior stretch, Acromioclavicular joint mobilization, Posterior capsular stretch
three of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder.
| Study group | Role | What they receive |
|---|---|---|
| Rotator Cuff Facilitation | Experimental | The function of Rotator cuff muscles is passively augmented in one of the 5 trials Receives: Other: pragmatic manual therapies |
| Serratus Anterior Stretch | Experimental | Seratus anterior muscles is stretched through a novel technique Receives: Other: pragmatic manual therapies |
| Posterior Capsular Stertch | Experimental | Posterior capsule is stretched through a novel maneuver Receives: Other: pragmatic manual therapies |
| Acromioclavicular Joint Mobilization | Experimental | Acromio clavicular joint is mobilized posterio-anterior Receives: Other: pragmatic manual therapies |
| Pragmatic Interventions | Experimental | The pragmatic interventions is a set of interventions which include
1. Rotator cuff facilitation
2. Posterior capsular stretch
3. Serratus anterior muscle stretch
4. Acromioclaicualr joint mobilization
5. Thoracic spine manipulation and
6. Stretch to the subclavious muscles Receives: Other: pragmatic manual therapies |
What is being measured
The primary outcome is the main question the study is designed to answer.
Shoulder External Rotation
The change in external rotation range will be assessed at baseline and soon after the application of intervention in each of the trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.
Measured: 12 months
Shoulder Internal Rotation
The change in internal rotation range will be assessed at baseline and soon after the application of in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.
Measured: 12 months
Shoulder Abduction Range
The change in abduction range will be assessed at baseline and soon after the application of intervention in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.
Measured: 12 months
Shoulder Flexion
The change in Flexion range will be assessed at baseline and soon after the application of intervention in each trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.
Measured: 12 months
Reaching Up Behind the Back
The change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.
Measured: 12 months
Reaching Down Behind the Neck
the change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.
Measured: 12 months
Shoulder pain and Disability Index Urdu version
Change in scores Shoulder pain and disability index Urdu version will be assessed at baseline line in subjects with shoulder pathology and at 6th week of the combined intervention protocol. Less score indicate improved pain and disability
Measured: 12 months
Secondary outcomes (1)
Subject feed back questions
Suject feedback through a self construct subjective questionaire regarding various aspect of the intervention/interventions will be evaluate
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start1 Apr 2018
- Primary completion2 Sep 2020
- Study completion1 Jan 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Non-randomised
- Intervention model
- Sequential
- Model description
- Four trial of a single group quasi experimental design on healthy subjects through individual intervention followed by similar trial on subject with shoulder pathology through combination of all intervention.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isra University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04242888
- Sponsor's protocol ID
- 1602-PhD-001
- Status last verified
- Dec 2020
- First submitted
- 14 Jan 2020
- Last updated
- 24 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available in two phases. work on the first part in progress and will be shared when available
Publications
Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16.
PubMed 20846766Cools AM, Declercq G, Cagnie B, Cambier D, Witvrouw E. Internal impingement in the tennis player: rehabilitation guidelines. Br J Sports Med. 2008 Mar;42(3):165-71. doi: 10.1136/bjsm.2007.036830. Epub 2007 Dec 10.
PubMed 18070811Phadke V, Camargo P, Ludewig P. Scapular and rotator cuff muscle activity during arm elevation: A review of normal function and alterations with shoulder impingement. Rev Bras Fisioter. 2009 Feb 1;13(1):1-9. doi: 10.1590/S1413-35552009005000012.
PubMed 20411160Teyhen DS, Miller JM, Middag TR, Kane EJ. Rotator cuff fatigue and glenohumeral kinematics in participants without shoulder dysfunction. J Athl Train. 2008 Jul-Aug;43(4):352-8. doi: 10.4085/1062-6050-43.4.352.
PubMed 18668167Wilk KE, Hooks TR, Macrina LC. The modified sleeper stretch and modified cross-body stretch to increase shoulder internal rotation range of motion in the overhead throwing athlete. J Orthop Sports Phys Ther. 2013 Dec;43(12):891-4. doi: 10.2519/jospt.2013.4990. Epub 2013 Oct 30.
PubMed 24175603Chopp JN, O'Neill JM, Hurley K, Dickerson CR. Superior humeral head migration occurs after a protocol designed to fatigue the rotator cuff: a radiographic analysis. J Shoulder Elbow Surg. 2010 Dec;19(8):1137-44. doi: 10.1016/j.jse.2010.03.017. Epub 2010 Jul 3.
PubMed 20598916Kibler WB, Sciascia A. Current concepts: scapular dyskinesis. Br J Sports Med. 2010 Apr;44(5):300-5. doi: 10.1136/bjsm.2009.058834. Epub 2009 Dec 8.
PubMed 19996329Ekstrom RA, Donatelli RA, Soderberg GL. Surface electromyographic analysis of exercises for the trapezius and serratus anterior muscles. J Orthop Sports Phys Ther. 2003 May;33(5):247-58. doi: 10.2519/jospt.2003.33.5.247.
PubMed 12774999Keramat Ullah Keramat. Conservative treatment preferences and the plausible mechanism of Neer's stage 1 of shoulder impingement in younger people. J Pak Med Assoc. 2015 May;65(5):542-7.
PubMed 26028390Keramat KU, Mc Creesh K, Kropmans T. Voluntary Co-Contraction Exercise Effective In Early Stage Of Subacromial Impingement Syndrome Management. International Journal of Rehabilitation Sciences (IJRS). 2017;4(02):7-13.
Keramat 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 33062302
Study at a glance
From the registry record, last updated by the sponsor on 24 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Acute Effects of Pragmatic Manual Therapy on the Range of Motion of Shoulder Joint
- ClinicalTrials.gov ID
- NCT04242888
- Acronym / sponsor ID
- 1602-PhD-001
- Conditions
- Shoulder Impingement, Prehabilitation, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Isra UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 2 Sep 2020 (actual)
- Study completion
- 1 Jan 2021 (estimated)
- First posted
- 27 Jan 2020 (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.
Current studies on the mechanism of subacromial impingement and other shoulder pathology reveal that multiple factors are responsible for impingement. These include serratus anterior dysfunction, rotator cuff insufficiency, posterior capsular tightness, acromioclavicular joint, thoracic spine stiffness and extensibility of the pectoralis minor and subclavius muscles. Manual intervention should therefore address these issues in conjunction with the other therapies. Novel interventions have been designed pilot tested for each of these factors to produce a healing environment. The purpose of this study is to evaluate the effects of each individual factor and combination of all on the range of motion of shoulder joint in healthy subjects and subjects with a restricted range of motion of shoulder joint respectively. The subject will be allocated randomly into four groups with respect to objective 1 and each of the groups will be evaluated as a quasi-experiment design (pretest-posttest) for healthy each of 30 subjects. Beneficial intervention among the four trials and other previously reported beneficial in improving the shoulder joint range will be combined in and termed as pragmatic intervention protocols. Pragmatic interventions on subjects with the restricted range in shoulder pathology will be tested through a similar design. The effects of these interventions on the Quality of life measured through the Urdu version of Shoulder pain and disability in subjects with shoulder pathology will also be tested.
Detailed description
Shoulder disorders are the 3rd commonest among musculoskeletal conditions. Its prevalence is estimated 7-26% at one point of time and 67% of the individuals experience shoulder pain once in their life. Subacromial impingements (SAIS) are the frequent diagnosis accounting for 45-65% of all shoulder disorders. It is defined as "a condition in which the tendons of the rotator cuff muscles, long head of the biceps or the subacromial bursa are entrapped between the humeral head inferiorly and anterior acromion superiorly.
Multiple researchers have studied interventions which affect the shoulder range of motions. Thoracic spine manipulation improves the shoulder range of motion. Similarly, Stretching the pectorallis minor muscles improve shoulder kinematics. Manual intervention for subscapularis, infra spinatus, and serratus anterior are non-existent to investigators' knowledge. Modification to stretch the posterior capsule in a pragmatic manner is described and recommended but trials are nonexistent. Acromioclavicular joint being the part of the scapolo-glenohumeral complex has a role to play in the kinematics of the shoulder but trials on its mobilization with respect to shoulder range of motion are not been studies. These gaps in research in relation to understanding of the mechanism of shoulder pathology and subsequent intervention are also identified but trials and interventions are non-existent.
The understanding of the complex relations of the intrinsic and extrinsic factors necessitates the development of manual therapy interventions to address the factors which are adversely affect range of motion of shoulder joint. The purpose of this research is to develop and propose manual therapy interventions for shoulder joint which can effectively address the limitations in shoulder joint ranges of motion in both healthy subjects and subjects with shoulder pathology having decrease range of motion through a series of primitive trials.
AIMES AND OBJECTIVES The primary purpose of this study is to evaluate the short term effects of Pragmatic manual interventions on range of motion of the shoulder joint in healthy individual and individuals with shoulder pathology who have restricted ranges of motion .The aims of this study are therefore to
- To evaluate the effects of pragmatic interventions in healthy asymptomatic subjects with respect to the changes in shoulder joint restricted range of motion
- To evaluate the effects of interventions in symptomatic shoulder individual with restriction in their shoulder range of motion and short term change in the shoulder related quality of life and pain MATERIAL AND METHOD A single group quasi-experimental (pretest-posttest) design will be used for all the trials in this study. It will be conducted at Helping Hand Institute of Rehabilitation Sciences, Mansehra. The study will be composed of 4 trials in the first phase on healthy subject with respect to each of the proposed pragmatic (novice) intervention consistent with the first objective and exploratory in nature. Subjects will be randomly allocated to the initial four groups. The initial 4 trials on healthy subjects are chosen since the effects of each of the proposed pragmatic interventions is not been studied but advocated. Healthy subjects with restriction in shoulder ROM are deemed appropriate since other confounding factors such as pain is absent and objectives could be achieved. In Phase 2, trial on patient with shoulder pathology will be conducted after evaluating the effects on range of motion in healthy individual. Each trial will recruit 30 subjects. subjects in trial 5 with shoulder pathology will be assessed through Urdu version of shoulder pain and disability index at baseline, after one week and 5 weeks of pragmatic interventions. A sample size of 30 for each trial ( a total of 150 subject) is deemed appropriate after a pilot trial on 5 healthy subject which produced a meaningful difference of 15 degree change in abduction, and 3 cm difference in reaching up behind the back and using standard deviation estimates from previous studies. Finally, The urdu translated and validated version of SPADI will used to measure shoulder related pain and Disability. Ethical approval will be sought from REC Isra university and Ethical committee of HHIRS. Subjects consent will be taken in writing (annex 2) and full study information will be given (annex 3). Each of Phase 1 and phase 2 of this study will be completed in 6 months (a total of 1 year) from August 2019 to August 2020.
SUBJECTS ASSESSMENT PROCEDURE For healthy subject of the initial 4 trials, subjects willing to participate will be screened against the inclusion and exclusion criteria. Each participant for trial 5 with shoulder pathologies will be assessed thoroughly and screened against the inclusion and exclusion criteria. Demographic information, information related to history of the presenting complaint, past medical and surgical history, hobbies, occupation, drug history and social history will be collected from all the eligible subjects in trial 5. Additional information in relation to date of onset, behavior of symptoms, aggravating, easing factors, previous treatment including injection and other surgical interventions, relevant investigation will be collected.
A detailed objective examination process will be followed for participants in trial 5. Examination process will include inspection of the shoulders, cervical spine and thoracic spine from the front, each side and back. Any abnormality seen will be documented.
Inspection will be followed by ruling out any pathology of the neck by asking the patient to perform active neck rotation to each side, side flexion, extension and flexion and any pain, discomfort and paraesthesia will be noted. These quick movements are assumed sufficient to rule out any pathology of the neck. Neck movements will be followed by the active elevation (flexion and abduction) of the shoulder joint and any pain, restriction in range and willingness to movement will be noted. Active reaching behind the back will be performed and any limitation in comparison with the asymptomatic side noted. Limitation will be measures from the respective posterior superior iliac spine though measuring tape. Active elation of the arm is followed by the passive movements of abduction, flexion, and medial rotation. Any limitation of range, end feel and pain will be noted during each of the passive movement. Active resisted movement of abduction, medial rotation, later rotation of shoulder and flexion and extension of elbow are followed and strength/pain will be noted. The systematic procedure of assessment followed from Cyriax and has been found highly reliable(39) and assessment procedure including similar procedures Special test such as Neer's sign, Hawkin kennedy test, scarf test, speed test, O'brien's test will be administered to determine SAIS.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 5
- Model description
- Four trial of a single group quasi experimental design on healthy subjects through individual intervention followed by similar trial on subject with shoulder pathology through combination of all intervention.
| Arm | Type | Receives |
|---|---|---|
| Rotator Cuff Facilitation | Experimental | Other: pragmatic manual therapiesThe function of Rotator cuff muscles is passively augmented in one of the 5 trials |
| Serratus Anterior Stretch | Experimental | Other: pragmatic manual therapiesSeratus anterior muscles is stretched through a novel technique |
| Posterior Capsular Stertch | Experimental | Other: pragmatic manual therapiesPosterior capsule is stretched through a novel maneuver |
| Acromioclavicular Joint Mobilization | Experimental | Other: pragmatic manual therapiesAcromio clavicular joint is mobilized posterio-anterior |
| Pragmatic Interventions | Experimental | Other: pragmatic manual therapiesThe pragmatic interventions is a set of interventions which include 1. Rotator cuff facilitation 2. Posterior capsular stretch 3. Serratus anterior muscle stretch 4. Acromioclaicualr joint mobilization 5. Thoracic spine manipulation and 6. Stretch to the subclavious muscles |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- For trial 1-4
- main complaint in gleno-humeral joint
- Limitation in Range of motion of Abduction or internal rotation or external rotation or reaching up behind the back or reaching down behind down the neck , all or only one of the limitation in comparison with the unaffected joint.
Key exclusion criteria (13 listed)
- For trial 1-4
- <!-- -->
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 manual therapiesAlso: Rotator cuff facilitation, Serratus anterior stretch, Acromioclavicular joint mobilization, Posterior capsular stretchthree of the intervention are novel and the rest of the interventions are in practice but seldom used to treat the shoulder disorder. | Other | Acromioclavicular Joint Mobilization, Posterior Capsular Stertch, Pragmatic Interventions, Rotator Cuff Facilitation, Serratus Anterior Stretch |
Primary outcome
Shoulder External Rotation
Time frame: 12 months
The change in external rotation range will be assessed at baseline and soon after the application of intervention in each of the trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.
Shoulder Internal Rotation
Time frame: 12 months
The change in internal rotation range will be assessed at baseline and soon after the application of in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.
Shoulder Abduction Range
Time frame: 12 months
The change in abduction range will be assessed at baseline and soon after the application of intervention in each of the trial.A higher score indicate improvement. A digital inclinometer will be used for measurement.
Shoulder Flexion
Time frame: 12 months
The change in Flexion range will be assessed at baseline and soon after the application of intervention in each trial. A higher score indicate improvement. A digital inclinometer will be used for measurement.
Reaching Up Behind the Back
Time frame: 12 months
The change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.
Reaching Down Behind the Neck
Time frame: 12 months
the change in the distance between tip of the middle finger of one hand and the thumb of the other hand will be measured through measuring tap in each trial, as measured in functional movement screen.A lower difference between the scors indicates improvement.
Shoulder pain and Disability Index Urdu version
Time frame: 12 months
Change in scores Shoulder pain and disability index Urdu version will be assessed at baseline line in subjects with shoulder pathology and at 6th week of the combined intervention protocol. Less score indicate improved pain and disability
1 secondary outcome
Subject feed back questions
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2020.
- Background: PubMed 20846766Seitz AL, McClure PW, Finucane S, Boardman ND 3rd, Michener LA. Mechanisms of rotator cuff tendinopathy: intrinsic, extrinsic, or both? Clin Biomech (Bristol). 2011 Jan;26(1):1-12. doi: 10.1016/j.clinbiomech.2010.08.001. Epub 2010 Sep 16.
- Background: PubMed 18070811Cools AM, Declercq G, Cagnie B, Cambier D, Witvrouw E. Internal impingement in the tennis player: rehabilitation guidelines. Br J Sports Med. 2008 Mar;42(3):165-71. doi: 10.1136/bjsm.2007.036830. Epub 2007 Dec 10.
- Background: PubMed 20411160Phadke V, Camargo P, Ludewig P. Scapular and rotator cuff muscle activity during arm elevation: A review of normal function and alterations with shoulder impingement. Rev Bras Fisioter. 2009 Feb 1;13(1):1-9. doi: 10.1590/S1413-35552009005000012.
- Background: PubMed 18668167Teyhen DS, Miller JM, Middag TR, Kane EJ. Rotator cuff fatigue and glenohumeral kinematics in participants without shoulder dysfunction. J Athl Train. 2008 Jul-Aug;43(4):352-8. doi: 10.4085/1062-6050-43.4.352.
- Background: PubMed 24175603Wilk KE, Hooks TR, Macrina LC. The modified sleeper stretch and modified cross-body stretch to increase shoulder internal rotation range of motion in the overhead throwing athlete. J Orthop Sports Phys Ther. 2013 Dec;43(12):891-4. doi: 10.2519/jospt.2013.4990. Epub 2013 Oct 30.
- Background: PubMed 20598916Chopp JN, O'Neill JM, Hurley K, Dickerson CR. Superior humeral head migration occurs after a protocol designed to fatigue the rotator cuff: a radiographic analysis. J Shoulder Elbow Surg. 2010 Dec;19(8):1137-44. doi: 10.1016/j.jse.2010.03.017. Epub 2010 Jul 3.
- Background: PubMed 19996329Kibler WB, Sciascia A. Current concepts: scapular dyskinesis. Br J Sports Med. 2010 Apr;44(5):300-5. doi: 10.1136/bjsm.2009.058834. Epub 2009 Dec 8.
- Background: PubMed 12774999Ekstrom RA, Donatelli RA, Soderberg GL. Surface electromyographic analysis of exercises for the trapezius and serratus anterior muscles. J Orthop Sports Phys Ther. 2003 May;33(5):247-58. doi: 10.2519/jospt.2003.33.5.247.
- Results publication: PubMed 26028390Keramat Ullah Keramat. Conservative treatment preferences and the plausible mechanism of Neer's stage 1 of shoulder impingement in younger people. J Pak Med Assoc. 2015 May;65(5):542-7.
- Results publicationKeramat KU, Mc Creesh K, Kropmans T. Voluntary Co-Contraction Exercise Effective In Early Stage Of Subacromial Impingement Syndrome Management. International Journal of Rehabilitation Sciences (IJRS). 2017;4(02):7-13.
- Derived from this study: 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.
- Individual participant dataSharing planned: No. Data will be available in two phases. work on the first part in progress and will be shared when available
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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.
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 manual therapies in people with Shoulder Impingement and Prehabilitation, run by Isra 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 5 inclusion and 13 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 24 Dec 2020. 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, M.Phil (+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 External Rotation (time frame: 12 months). The study lists 7 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 NCT04242888, which also lists 11 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 24 Dec 2020.