- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04859387
Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy (PSTVSTPT)
May 28, 2021 updated by: Helping Hand Institute of Rehabilitation Sciences
Effectiveness of Pragmatic Shoulder Techniques in Comparison With Traditional Physical Therapy in Patients With Shoulder Pathologies
Isolated and combined effectiveness of pragmatic protocols on shoulder range of motion had been investigated and found effective in healthy participants.
To our knowledge, there was insufficient literature to support the comparison between pragmatic and traditional protocols in the treatment of shoulder pathologies.
Study Overview
Status
Completed
Intervention / Treatment
Detailed Description
Different physical therapy treatments are being used for shoulder pathologies which include modalities (hot pack, TENS), ROM exercises, stretching, strengthening, soft tissue mobilization and set of pragmatic manual techniques.The set of pragmatic manual therapies are novel techniques (comprises of acromioclavicular mobilization, serratus anterior stretch, thoracic manipulation, RC facilitation, and PCS) and its isolated effectiveness on ROM in healthy subjects has been investigated and found effective.
These studies recommended the use of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and pathologies (unpublished data).As per our knowledge there is insufficient literature to support the comparison of the effectiveness of a set of pragmatic protocols with traditional interventions.
Our research is proposed to compare the efficacy of pragmatic interventions with that of traditional interventions in patients with shoulder pathology and their effect on the quality of life.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
KPK
-
Mansehra, KPK, Pakistan, 21300
- Helping hand Institute of Rehabilitation Sciences Trust
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Functional movement score 1 and 2 or limitation in Range of motion of Abduction, internal rotation, external rotation, RUBB, and RDBN. All or only one of the limitations in comparison with the unaffected shoulder joint.
Exclusion Criteria:
- Patients with shoulder instability. Functional movement score 3 and 0. Individuals with recent fractures of fewer than 6 weeks duration. Cancerous Growth around the shoulder girdle. Breast cancer and undergoing chemotherapy and radiotherapy. RA arthritis patients. Long-term use of steroids and severe osteoporosis.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NON_RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: group A
set of pragmatic shoulder techniques
|
Group A received pragmatic intervention which includes Pectoralis major and minor stretch, AC joint mobilization, rotator cuff facilitation for subscapularis and infraspinatus, serratus anterior stretch, thoracic manipulation and posterior capsular stretch.
|
ACTIVE_COMPARATOR: group B
traditional physical therapy
|
Group B received traditional interventions which includes modalities such as TENS and hot pack, soft tissue mobilization, joint mobilization, stretching and strengthening etc. other than pragmatic intervention
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
shoulder Range of motion
Time Frame: 5 days
|
will be measured in degrees by digital inclinometer
|
5 days
|
functional movements
Time Frame: 5 days
|
will be measured in centimeters by inchi tape
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Keramat Ullah Keramat, Ph.D*, HHIRS Trust
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- Keramat KU, Babar MN. Serratus Anterior Stretch: A Novel Intervention and Its Effect on the Shoulder Range of Motion. J Sport Rehabil. 2021 Jan 8;30(5):824-827. doi: 10.1123/jsr.2020-0121.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
April 15, 2020
Primary Completion (ACTUAL)
July 30, 2020
Study Completion (ACTUAL)
September 23, 2020
Study Registration Dates
First Submitted
April 15, 2021
First Submitted That Met QC Criteria
April 23, 2021
First Posted (ACTUAL)
April 26, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 2, 2021
Last Update Submitted That Met QC Criteria
May 28, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Rec-2020-F-002
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
as per the decision of helping hand research ethical committee (HHREC)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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