NCT04859387

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
49

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 15, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 30, 2020

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2020

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 15, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

April 26, 2021

Completed
Last Updated

June 2, 2021

Status Verified

April 1, 2021

Enrollment Period

4 months

First QC Date

April 15, 2021

Last Update Submit

May 28, 2021

Conditions

Keywords

pragmatic intervention,shoulder pathologies,shoulder pain,shoulder range of motionpragmatic shoulder intervention,

Outcome Measures

Primary Outcomes (2)

  • shoulder Range of motion

    will be measured in degrees by digital inclinometer

    5 days

  • functional movements

    will be measured in centimeters by inchi tape

    5 days

Study Arms (2)

group A

EXPERIMENTAL

set of pragmatic shoulder techniques

Other: set of pragmatic shoulder technique

group B

ACTIVE COMPARATOR

traditional physical therapy

Other: traditional physical therapy

Interventions

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.

group A

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

group B

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Helping hand Institute of Rehabilitation Sciences Trust

Mansehra, KPK, 21300, Pakistan

Location

Related Publications (2)

  • 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.

    PMID: 33062302BACKGROUND
  • 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.

    PMID: 33418538BACKGROUND

MeSH Terms

Conditions

Shoulder PainShoulder Impingement SyndromeShoulder InjuriesBursitis

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsWounds and Injuries

Study Officials

  • Keramat Ullah Keramat, Ph.D*

    HHIRS Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: quasi-experimental
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 15, 2021

First Posted

April 26, 2021

Study Start

April 15, 2020

Primary Completion

July 30, 2020

Study Completion

September 23, 2020

Last Updated

June 2, 2021

Record last verified: 2021-04

Data Sharing

IPD Sharing
Will not share

as per the decision of helping hand research ethical committee (HHREC)

Locations