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

• ClinicalTrials.gov Identifier: NCT04859387
• Recruitment Status: Completed
• First Posted: April 26, 2021
• Last Update Posted: June 2, 2021
• Sponsor: Helping Hand Institute of Rehabilitation Sciences
• Information provided by (Responsible Party): Helping Hand Institute of Rehabilitation Sciences

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.

Condition or disease	Intervention/treatment	Phase
Shoulder Pain; Shoulder Impingement; Shoulder Injuries; Frozen Shoulder; Shoulder Capsulitis	Other: set of pragmatic shoulder technique; Other: traditional physical therapy	Not Applicable

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recommended the use of a pragmatic protocol for the prevention and rehabilitation of shoulder injuries and pathologies (unpublished data).As per our knowledge there is insufficient literature to support the comparison of the effectiveness of a set of pragmatic protocols with traditional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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 49 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: quasi-experimental
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of Pragmatic Shoulder Techniques in Comparison With Traditional Physical Therapy in Patients With Shoulder Pathologies
• Actual Study Start Date: April 15, 2020
• Actual Primary Completion Date: July 30, 2020
• Actual Study Completion Date: September 23, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: group A; set of pragmatic shoulder techniques	Other: set of pragmatic shoulder technique; 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	Other: 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

Outcome Measures

Primary Outcome Measures :

1. shoulder Range of motion [ Time Frame: 5 days ]
   will be measured in degrees by digital inclinometer
2. functional movements [ Time Frame: 5 days ]
   will be measured in centimeters by inchi tape

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Pakistan

Helping hand Institute of Rehabilitation Sciences Trust

Mansehra, KPK, Pakistan, 21300

Sponsors and Collaborators

Helping Hand Institute of Rehabilitation Sciences

Investigators

• Principal Investigator: Keramat Ullah Keramat, Ph.D*; HHIRS Trust

More Information

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.

• Responsible Party: Helping Hand Institute of Rehabilitation Sciences
• ClinicalTrials.gov Identifier: NCT04859387
• Other Study ID Numbers: Rec-2020-F-002
• First Posted: April 26, 2021
• Last Update Posted: June 2, 2021
• Last Verified: April 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: as per the decision of helping hand research ethical committee (HHREC)

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helping Hand Institute of Rehabilitation Sciences:

pragmatic intervention,; shoulder pathologies,; shoulder pain,; shoulder range of motion; pragmatic shoulder intervention,

Additional relevant MeSH terms:

Shoulder Pain; Bursitis; Shoulder Impingement Syndrome; Shoulder Injuries; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Wounds and Injuries