NCT06469502

Brief Summary

The aim of the study is to compare the effectiveness of stretching and strengthening exercises on pain, functional status, range of motion and psychosocial factors in patients with frozen shoulder.

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
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Geographic Reach
1 country

1 active site

Status
not yet recruiting

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

June 7, 2024

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 21, 2024

Completed
10 days until next milestone

Study Start

First participant enrolled

July 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

June 21, 2024

Status Verified

June 1, 2024

Enrollment Period

1 year

First QC Date

June 7, 2024

Last Update Submit

June 17, 2024

Conditions

Keywords

frozen shoulderexercisestretchingstrengthening

Outcome Measures

Primary Outcomes (2)

  • Quick DASH

    Quick Disabilities of the Arm, Shoulder, and Hand: The Quick DASH is a 11-item questionnaire used to assess upper limb functionality. The score ranges from 0 (no disability) to 100 (most severe disability).

    baseline, after 6 weeks and 6 weeks follow up

  • NPRS

    Numeric Pain Rating Scale: The pain was measured using a NPRS. Patients are asked to rate their pain ranging from 0 to 10 (0: no pain, 10: the worst pain imaginable)

    baseline, after 6 weeks and 6 weeks follow up

Secondary Outcomes (4)

  • ASES

    baseline, after 6 weeks and 6 weeks follow up

  • Shoulder Range of Motion (ROM)

    baseline, after 6 weeks and 6 weeks follow up

  • BPI-SF

    baseline, after 6 weeks and 6 weeks follow up

  • PCS

    baseline, after 6 weeks and 6 weeks follow up

Study Arms (2)

Group 1-Stretching Group

EXPERIMENTAL

Exercise program consisting of supervised stretching exercises

Procedure: Stretching Exercises

Group 2-Strengthening Group

EXPERIMENTAL

Exercise program consisting of supervised strengthening exercises

Procedure: Strengthening Exercises

Interventions

Group 1 will be included in the program consisting of stretching exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of stretching exercises (3 times a week) under the supervision of a physiotherapist.

Group 1-Stretching Group

Group 2 will be included in the program consisting of strengthening exercises only. Patients will receive a 6-week rehabilitation program consisting of 18 sessions of strengthening exercises (3 times a week) under the supervision of a physiotherapist.

Group 2-Strengthening Group

Eligibility Criteria

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

You may qualify if:

  • Being between the ages of 40-65
  • Clinical and radiologic diagnosis of unilateral primary frozen shoulder
  • Being in frozen shoulder stages 2 and 3
  • Having an ROM of less than 50% in one or more directions of shoulder flexion, abduction, external rotation compared to the unaffected shoulder
  • Giving informed consent and volunteering
  • To have the ability to understand evaluation scales

You may not qualify if:

  • Neurological, cardiovascular, cerebrovascular disease
  • Those with severe mental illness or impaired consciousness
  • Upper extremity fractures and tumors
  • Rheumatic disease
  • Pathologies of cervical origin
  • Untreated shoulder trauma
  • Severe osteoporosis
  • Previous treatment for the current complaint (physiotherapy and rehabilitation, intra-articular injection, surgery)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

BursitisMotor Activity

Interventions

Muscle Stretching Exercises

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Ümmü Öztürk, PhD(c)

CONTACT

Derya Çelik, Professor

CONTACT

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
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

June 7, 2024

First Posted

June 21, 2024

Study Start

July 1, 2024

Primary Completion

July 1, 2025

Study Completion

August 15, 2025

Last Updated

June 21, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will share

Locations