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Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis

Primary Purpose

Adhesive Capsulitis

Status

Recruiting

Phase

Not Applicable

Locations

Pakistan

Study Type

Interventional

Intervention

Mobilization

Cyriax capsular stretching

About this trial

This is an interventional treatment trial for Adhesive Capsulitis focused on measuring Range of motion, Shoulder, Pain

Eligibility Criteria

30 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Both genders Age : 30-50 years Pain and Restricted movements of shoulder. Patient With Adhesive Capsulitis of Stage 2 Exclusion Criteria: Patient with any Intrinsic Etiology such as Haemarthrosis, rheumatoid arthritis ,infection or gout Patient with any severe trauma, Shoulder dislocation, subluxation or ligament injury of the shoulder Fractures of the shoulder Peripheral neurological involvement in the upper extremity.

Sites / Locations

Lady reading hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cyriax capsular stretching

Mobilization

Arm Description

Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises.Anterior, Posterior and inferior capsular stretching.

Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises and Maitland's Mobilization:

Outcomes

Primary Outcome Measures

Numeric Pain rating scale

The Numeric Pain rating scale is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain.

Range of motion (shoulder flexion)

changes in shoulder flexion Range of motion from baseline to final session was measured

Range of motion (shoulder extension)

changes in shoulder extension Range of motion from baseline to final session was measured

Range of motion (shoulder abduction)

changes in shoulder abduction Range of motion from baseline to final session was measured

Range of motion (shoulder external rotation)

changes in shoulder external rotation Range of motion from baseline to final session was measured

Range of motion (internal rotation)

changes in shoulder internal rotation Range of motion from baseline to final session was measured

Secondary Outcome Measures

Full Information

NCT ID

NCT05903768

First Posted

June 6, 2023

Last Updated

June 13, 2023

Sponsor

Riphah International University

1. Study Identification

Unique Protocol Identification Number

NCT05903768

Brief Title

Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis

Official Title

Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2022 (Actual)

Primary Completion Date

June 15, 2023 (Anticipated)

Study Completion Date

June 20, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Riphah International University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

The aim of this research is to determine the effects of capsular stretching versus passive joint mobilization on Pain, range of motion and Quality of life in patients with Idiopathic Adhesive capsulitis.

Detailed Description

In reference study, patients with Adhesive capsulitis were given the option to examine the immediate effects of posterior capsule stretching and scapular mobilization. They came to the conclusion that extending the posterior capsule improved shoulder range of motion. Current study will assess all shoulder movements and also showing effect on Quality of life of patients with adhesive capsulitis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Adhesive Capsulitis

Keywords

Range of motion, Shoulder, Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

38 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Cyriax capsular stretching

Arm Type

Experimental

Arm Description

Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises.Anterior, Posterior and inferior capsular stretching.

Arm Title

Mobilization

Arm Type

Active Comparator

Arm Description

Patient will be subjected to Hot Pack prior to treatment. Detailed intervention will include Active range of motion exercises,Home plan exercises and Maitland's Mobilization:

Intervention Type

Other

Intervention Name(s)

Mobilization

Intervention Description

Hot Pack for 5mins,Active range of motion exercises (10 reps x 3 sets),Home plan include: wand exercises, wall-walking exercises, pendulum exercises,towel stretch exercises, Cross Body Adduction (10reps x 2 sets, each)Cold pack for 5 mins. Maitland's Mobilization: Inferior glide (10x3), posterior glide, (10 reps x 3 sets), anterior glide (10 reps x 3 sets)

Intervention Type

Other

Intervention Name(s)

Cyriax capsular stretching

Intervention Description

Hot Pack for 5mins,Active range of motion exercises (10 reps x 3 sets),Home plan include: wand exercises, wall-walking exercises, pendulum exercises,towel stretch exercises, Cross Body Adduction (10reps x 2 sets, each)Cold pack for 5 mins. Anterior, Posterior and inferior capsular stretching would be performed. Each stretch should be held15-30 seconds and repeated 2 to 4 times.

Primary Outcome Measure Information:

Title

Numeric Pain rating scale

Description

Time Frame

4th week

Title

Range of motion (shoulder flexion)

Description

changes in shoulder flexion Range of motion from baseline to final session was measured

Time Frame

4th week

Title

Range of motion (shoulder extension)

Description

changes in shoulder extension Range of motion from baseline to final session was measured

Time Frame

4th week

Title

Range of motion (shoulder abduction)

Description

changes in shoulder abduction Range of motion from baseline to final session was measured

Time Frame

4th week

Title

Range of motion (shoulder external rotation)

Description

changes in shoulder external rotation Range of motion from baseline to final session was measured

Time Frame

4th week

Title

Range of motion (internal rotation)

Description

changes in shoulder internal rotation Range of motion from baseline to final session was measured

Time Frame

4th week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Imran Amjad, Phd

Phone

03324390125

imran.amjad@riphah.edu.pk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ramsha Tariq, MS-OMPT

Organizational Affiliation

Riphah International University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Lady reading hospital

City

Peshawar

State/Province

Khyber Pakhtunkhwa

ZIP/Postal Code

25000

Country

Pakistan

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Ramsha Tariq, MSOMPT

Phone

03315251422

ramsha.tariq@riphah.edu.pk

First Name & Middle Initial & Last Name & Degree

Maria Safdar, MS-OMPT

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34425597

Citation

Eckert AJ, Plaumann M, Pehlke S, Beck C, Muhldorfer S, Weickert U, Laimer M, Pfeifer M, Stechemesser L, Holl R. Idiopathic Frozen Shoulder in Individuals with Diabetes: Association with Metabolic Control, Obesity, Antidiabetic Treatment and Demographic Characteristics in Adults with Type 1 or 2 Diabetes from the DPV Registry. Exp Clin Endocrinol Diabetes. 2022 Jul;130(7):468-474. doi: 10.1055/a-1543-8559. Epub 2021 Aug 23.

Results Reference

background

PubMed Identifier

18061115

Citation

Thomas SJ, McDougall C, Brown ID, Jaberoo MC, Stearns A, Ashraf R, Fisher M, Kelly IG. Prevalence of symptoms and signs of shoulder problems in people with diabetes mellitus. J Shoulder Elbow Surg. 2007 Nov-Dec;16(6):748-51. doi: 10.1016/j.jse.2007.02.133.

Results Reference

background

PubMed Identifier

15358849

Citation

Mengiardi B, Pfirrmann CW, Gerber C, Hodler J, Zanetti M. Frozen shoulder: MR arthrographic findings. Radiology. 2004 Nov;233(2):486-92. doi: 10.1148/radiol.2332031219. Epub 2004 Sep 9.

Results Reference

background

PubMed Identifier

35035234

Citation

Janela D, Costa F, Molinos M, Moulder RG, Lains J, Francisco GE, Bento V, Cohen SP, Correia FD. Asynchronous and Tailored Digital Rehabilitation of Chronic Shoulder Pain: A Prospective Longitudinal Cohort Study. J Pain Res. 2022 Jan 8;15:53-66. doi: 10.2147/JPR.S343308. eCollection 2022.

Results Reference

background

PubMed Identifier

24664198

Citation

Paul A, Rajkumar JS, Peter S, Lambert L. Effectiveness of sustained stretching of the inferior capsule in the management of a frozen shoulder. Clin Orthop Relat Res. 2014 Jul;472(7):2262-8. doi: 10.1007/s11999-014-3581-2. Epub 2014 Mar 25.

Results Reference

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Comparison of Capsular Stretching and Passive Joint Mobilization in Idiopathic Adhesive Capsulitis

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