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Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy (PSTVSTPT)

Primary Purpose

Shoulder Pain, Shoulder Impingement, Shoulder Injuries

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
set of pragmatic shoulder technique
traditional physical therapy
Sponsored by
Helping Hand Institute of Rehabilitation Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring pragmatic intervention,, shoulder pathologies,, shoulder pain,, shoulder range of motion, pragmatic shoulder intervention,

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Helping hand Institute of Rehabilitation Sciences Trust

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

group A

group B

Arm Description

set of pragmatic shoulder techniques

traditional physical therapy

Outcomes

Primary Outcome Measures

shoulder Range of motion
will be measured in degrees by digital inclinometer
functional movements
will be measured in centimeters by inchi tape

Secondary Outcome Measures

Full Information

First Posted
April 15, 2021
Last Updated
May 28, 2021
Sponsor
Helping Hand Institute of Rehabilitation Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT04859387
Brief Title
Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy
Acronym
PSTVSTPT
Official Title
Effectiveness of Pragmatic Shoulder Techniques in Comparison With Traditional Physical Therapy in Patients With Shoulder Pathologies
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2020 (Actual)
Primary Completion Date
July 30, 2020 (Actual)
Study Completion Date
September 23, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Helping Hand Institute of Rehabilitation Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain, Shoulder Impingement, Shoulder Injuries, Frozen Shoulder, Shoulder Capsulitis
Keywords
pragmatic intervention,, shoulder pathologies,, shoulder pain,, shoulder range of motion, pragmatic shoulder intervention,

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
quasi-experimental
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
49 (Actual)

8. Arms, Groups, and Interventions

Arm Title
group A
Arm Type
Experimental
Arm Description
set of pragmatic shoulder techniques
Arm Title
group B
Arm Type
Active Comparator
Arm Description
traditional physical therapy
Intervention Type
Other
Intervention Name(s)
set of pragmatic shoulder technique
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
traditional physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
shoulder Range of motion
Description
will be measured in degrees by digital inclinometer
Time Frame
5 days
Title
functional movements
Description
will be measured in centimeters by inchi tape
Time Frame
5 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Keramat Ullah Keramat, Ph.D*
Organizational Affiliation
HHIRS Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Helping hand Institute of Rehabilitation Sciences Trust
City
Mansehra
State/Province
KPK
ZIP/Postal Code
21300
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
as per the decision of helping hand research ethical committee (HHREC)
Citations:
PubMed Identifier
33062302
Citation
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.
Results Reference
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PubMed Identifier
33418538
Citation
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.
Results Reference
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Effectiveness of Pragmatic Shoulder Technique VS Traditional Physical Therapy

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