NCT05064033

Brief Summary

The glenohumeral joint is an articulation between the glenoid of the scapula and the head of the humerus that is enclosed by a synovial capsule divided into three main components: anterior, posterior, and the axillary pouch. Symptoms of posterior capsule tightness are linked to altered shoulder biomechanics and impairments which includes glenohumeral internal rotation deficit, incomplete glenohumeral adduction, impaired inferior glenohumeral ligament (IGHL) function, and increased risk of impingement symptoms. In the literature the two techniques available for stretching posterior capsule are pragmatic posterior capsular stretch and sleeper stretch. Pragmatic posterior capsular stretch is therapist administered and sleeper stretch is patient-administered. The work on the pragmatic posterior capsular stretch is more specified and rational to mark the tightness in the posterior capsule.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2021

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

May 24, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

September 29, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 1, 2021

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 24, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 24, 2022

Completed
Last Updated

October 1, 2021

Status Verified

September 1, 2021

Enrollment Period

7 months

First QC Date

September 29, 2021

Last Update Submit

September 29, 2021

Conditions

Keywords

sleeper stretchshoulder pathologiesPosterior capsular tightnessshoulder range of motionpragmatic posterior capsular stretchpragmatic intervention

Outcome Measures

Primary Outcomes (2)

  • shoulder range of motion

    shoulder range of motion will be measured in degrees by using digital inclinometer

    6 weeks

  • shoulder pain

    shoulder pain will be measured by numeric pain rating scale

    6 weeks

Secondary Outcomes (3)

  • Shoulder related quality of life

    6 weeks

  • Shoulder disability

    6 weeks

  • satisfaction level of patient

    6 weeks

Study Arms (2)

GROUP A

EXPERIMENTAL

Pragmatic Set of intervention and posterior capsular stretch

Other: Pragmatic Set of intervention and posterior capsular stretch

GROUP B

ACTIVE COMPARATOR

Pragmatic Set of intervention and Sleeper Stretch

Other: Pragmatic Set of intervention and Sleeper Stretch

Interventions

Group 1 will receive a pragmatic set of interventions, including Serratus Anterior Stretch,Rotator Cuff Facilitation,Acromilcalavicular joint Mobilization,Stretch of Pectoralis Major and Minor,Thoracic Manipulation and posterior capsular stretch.

GROUP A

Group 2 will receive a pragmatic set of interventions, including Serratus Anterior Stretch, Rotator Cuff Facilitation, Acromilcalavicular joint Mobilization, Stretch of Pectoralis Major and Minor, Thoracic Manipulation and sleeper stretch.

GROUP B

Eligibility Criteria

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

You may qualify if:

  • Limitation in range of motion abduction or internal rotation or external rotation or reaching up behind the back or reaching behind down the neck are only one of the limitations in comparison with the unaffected joint.
  • A patient who fall in grade 1 and grade 2 of the shoulder mobility test of functional movement screening.

You may not qualify if:

  • Patient with shoulder ligamentous instability Functional movement Screening score 0 or 3. Cancerous growth around the shoulder girdle Rheumatoid arthritis patients The patient has a recent fracture of less than the 6th-week duration or shoulder dislocation.
  • Long term use of steroids Cervical joint dysfunction, radicular pain. Systemic diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

HHIRST

Mansehra, Khyber Pakhtunkhwa, 213000, Pakistan

RECRUITING

Related Publications (7)

  • Michener LA, McClure PW, Karduna AR. Anatomical and biomechanical mechanisms of subacromial impingement syndrome. Clin Biomech (Bristol). 2003 Jun;18(5):369-79. doi: 10.1016/s0268-0033(03)00047-0.

    PMID: 12763431BACKGROUND
  • Umer M, Qadir I, Azam M. Subacromial impingement syndrome. Orthop Rev (Pavia). 2012 May 9;4(2):e18. doi: 10.4081/or.2012.e18. Epub 2012 May 31.

    PMID: 22802986BACKGROUND
  • Cools AM, Johansson FR, Borms D, Maenhout A. Prevention of shoulder injuries in overhead athletes: a science-based approach. Braz J Phys Ther. 2015 Sep-Oct;19(5):331-9. doi: 10.1590/bjpt-rbf.2014.0109. Epub 2015 Sep 1.

    PMID: 26537804BACKGROUND
  • Lyons RP, Green A. Subscapularis tendon tears. J Am Acad Orthop Surg. 2005 Sep;13(5):353-63. doi: 10.5435/00124635-200509000-00009.

    PMID: 16148361BACKGROUND
  • Johnson JE, Fullmer JA, Nielsen CM, Johnson JK, Moorman CT 3rd. Glenohumeral Internal Rotation Deficit and Injuries: A Systematic Review and Meta-analysis. Orthop J Sports Med. 2018 May 22;6(5):2325967118773322. doi: 10.1177/2325967118773322. eCollection 2018 May.

    PMID: 29845083BACKGROUND
  • 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
  • Laudner KG, Sipes RC, Wilson JT. The acute effects of sleeper stretches on shoulder range of motion. J Athl Train. 2008 Jul-Aug;43(4):359-63. doi: 10.4085/1062-6050-43.4.359.

    PMID: 18668168BACKGROUND

MeSH Terms

Conditions

Shoulder Impingement SyndromeShoulder Injuries

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesWounds and Injuries

Study Officials

  • keramat ullah karamat, Ph.D.*

    HHIRST

    PRINCIPAL INVESTIGATOR

Central Study Contacts

keramat ullah karamat, Ph.D.*

CONTACT

Abdul Haseeb Bhutta, M.Phil

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized control trial(double-blind)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal HHIRS

Study Record Dates

First Submitted

September 29, 2021

First Posted

October 1, 2021

Study Start

May 24, 2021

Primary Completion

December 24, 2021

Study Completion

March 24, 2022

Last Updated

October 1, 2021

Record last verified: 2021-09

Data Sharing

IPD Sharing
Will not share

As per the decision of the research ethics committee.

Locations