NCT05988255

Brief Summary

This study will be conducted to compare the effectiveness of static progressive stretching using the joint active system (JAS) shoulder device with cyclic manual stretching and controls on shoulder range of motion (ROM), time to gain ROM, and function in patients with adhesive capsulitis. The study includes three groups. Group A (15 patients) will receive static progressive stretch using the JAS device. Group B (15 patients) will receive cyclic manual stretching in flexion, abduction, and external and internal rotations. Group C (15 patients) is a control group that will receive no treatment until the end of the study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
45

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2023

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2023

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 14, 2023

Completed
18 days until next milestone

Study Start

First participant enrolled

September 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2024

Completed
Last Updated

February 6, 2025

Status Verified

February 1, 2025

Enrollment Period

6 months

First QC Date

August 4, 2023

Last Update Submit

February 4, 2025

Conditions

Adhesive CapsulitisStretchPhysical Neglect

Keywords

Adhesive capsulitisStatic progressive stretch

Outcome Measures

Primary Outcomes (2)

  • Range of motion

    Shoulder flexion, extension, abduction, external rotation and internal rotation will be measured using Baseline Digital Absolute Axis Goniometer

    Three months

  • Function

    The patient will be advised to select the number that best reflects the intensity of their discomfort and the degree of trouble they are having using the affected shoulder using SPADI.

    Three months

Secondary Outcomes (1)

  • Time to gain range motion

    Three months

Study Arms (3)

Static progressive stretch

EXPERIMENTAL
Device: Static progressive stretching

Cyclic manual stretch

ACTIVE COMPARATOR
Other: Cyclic manual stretching

No treatment

NO INTERVENTION

Interventions

Static progressive stretchingDEVICE

A stretching technique applies a mechanical progressive stretch

Also known as: Stretching exercises
Static progressive stretch
Cyclic manual stretchingOTHER

A stretching technique applies an intermittent manual stretch

Also known as: Stretching exercises
Cyclic manual stretch

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients of both genders with unilateral primary adhesive capsulitis.
  • Patients aged between 40-65.
  • Pain duration of three months or more.
  • Range of motion loss of greater than 25% in at least 2 planes and passive external rotation loss that is greater than 50% of the uninvolved shoulder or less than 30° of external rotation.

You may not qualify if:

  • Previous surgery or manipulation under anesthesia.
  • Other conditions affecting the shoulder as (rheumatoid arthritis, osteoarthritis, rotator cuff disease, or malignancies).
  • Neurological deficits affecting shoulder function.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of physical therapy, Cairo University

Giza, 11432, Egypt

Location

MeSH Terms

Conditions

Bursitis

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
Participants were blinded to which treatment they would receive.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective single-blinded randomized controlled trial (therapy, level 1B)
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant lecturer

Study Record Dates

First Submitted

August 4, 2023

First Posted

August 14, 2023

Study Start

September 1, 2023

Primary Completion

March 1, 2024

Study Completion

April 5, 2024

Last Updated

February 6, 2025

Record last verified: 2025-02

Locations

EG(1)