NCT05903768

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
38

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2022

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

November 1, 2022

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

June 6, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 15, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
5 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2023

Completed
Last Updated

March 5, 2024

Status Verified

March 1, 2024

Enrollment Period

8 months

First QC Date

June 6, 2023

Last Update Submit

March 4, 2024

Conditions

Keywords

Range of motionShoulderPain

Outcome Measures

Primary Outcomes (6)

  • 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.

    4th week

  • Range of motion (shoulder flexion)

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

    4th week

  • Range of motion (shoulder extension)

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

    4th week

  • Range of motion (shoulder abduction)

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

    4th week

  • Range of motion (shoulder external rotation)

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

    4th week

  • Range of motion (internal rotation)

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

    4th week

Study Arms (2)

Cyriax capsular stretching

EXPERIMENTAL

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.

Other: Cyriax capsular stretching

Mobilization

ACTIVE COMPARATOR

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:

Other: Mobilization

Interventions

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)

Mobilization

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.

Cyriax capsular stretching

Eligibility Criteria

Age30 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Both genders
  • Age : 30-50 years
  • Pain and Restricted movements of shoulder.
  • Patient With Adhesive Capsulitis of Stage 2

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lady reading hospital

Peshawar, Khyber Pakhtunkhwa, 25000, Pakistan

Location

Related Publications (5)

  • 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.

    PMID: 34425597BACKGROUND
  • 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.

    PMID: 18061115BACKGROUND
  • 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.

    PMID: 15358849BACKGROUND
  • 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.

    PMID: 35035234BACKGROUND
  • 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.

    PMID: 24664198BACKGROUND

MeSH Terms

Conditions

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ramsha Tariq, MS-OMPT

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2023

First Posted

June 15, 2023

Study Start

November 1, 2022

Primary Completion

June 15, 2023

Study Completion

June 20, 2023

Last Updated

March 5, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations