NCT05213351

Brief Summary

The aim of this study is to compare the effects of two different exercise programs in patients with frozen shoulders.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2022

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

First Submitted

Initial submission to the registry

January 16, 2022

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 28, 2022

Completed
3 months until next milestone

Study Start

First participant enrolled

April 25, 2022

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 20, 2023

Completed
Last Updated

July 24, 2023

Status Verified

July 1, 2023

Enrollment Period

1.1 years

First QC Date

January 16, 2022

Last Update Submit

July 21, 2023

Conditions

Adhesive Capsulitis

Keywords

frozen shoulderexercisegraded motor imagery

Outcome Measures

Primary Outcomes (1)

  • Change from baseline The Shoulder Pain and Disability Index at 6th and 8th week

    The Shoulder Pain and Disability Index (SPADI) was developed to measure current shoulder pain and disability in an outpatient setting. The SPADI contains 13 items that assess two domains; a 5-item subscale that measures pain and an 8-item subscale that measures disability.

    Baseline,6th week and 8th week

Secondary Outcomes (6)

  • Change from baseline NPRS at 6th and 8th week

    Baseline,6th week and 8th week

  • Change from baseline range of motion at 6th and 8th week

    Baseline,6th week and 8th week

  • Change from baseline QuickDASH at 6th and 8th week

    Baseline,6th week and 8th week

  • Change from baseline two-point discrimination at 6th and 8th week

    Baseline,6th week and 8th week

  • Change from Pain Catastrophizing Scale at 6th and 8th week

    Baseline,6th week and 8th week

  • +1 more secondary outcomes

Study Arms (2)

Graded Motor İmagery

EXPERIMENTAL

Graded Motor İmagery (GMI) group will receive a treatment protocol consisting of Graded Motor Imagery, cold therapy, traditional exercises and home exercises.

Other: Graded Motor Imagery

Exercise

ACTIVE COMPARATOR

Exercise group will receive training involves mobilizations, stretching, specific exercises for the frozen shoulder.

Other: Exercise

Interventions

Graded Motor ImageryOTHER

Graded Motor Imagery program will be performed two times a week for six consecutive weeks and will include the following three steps: laterality training, imagined movements, and mirror therapy. 1. Right-left discrimination training (lateralization training) 2. Imagination of hand movements (motor imagery): 3. Mirror therapy Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.

Graded Motor İmagery
ExerciseOTHER

Treatments including traditional physiotherapy approaches; joint mobilizations, stretching, scapula focused exercises etc.

Exercise

Eligibility Criteria

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

You may qualify if:

  • Patients aged \>60 years
  • Patients with shoulder pain of at least six months' duration secondary to tendinopathy and/or partial rotator cuff tear;
  • Patients with ability to follow simple orders; iii)
  • Patients with ability to sign to provide informed consent

You may not qualify if:

  • Normal passive ROM
  • External ROM \< 30
  • To have received treatment (physiotherapy, intra-articular injection, surgery) related to the existing complaint
  • Pain \< 3 according to the numbered pain assessment scale

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

İstanbul University-Cerrahpasa

Istanbul, Turkey (Türkiye)

Location

Related Publications (1)

  • Yasaci Z, Celik D. Does Integration of Graded Motor Imagery Training Augment the Efficacy of a Multimodal Physiotherapy Program for Patients With Frozen Shoulder? A Randomized Controlled Trial. Clin Orthop Relat Res. 2025 Apr 1;483(4):707-716. doi: 10.1097/CORR.0000000000003252. Epub 2024 Sep 17.

    PMID: 39436270DERIVED

MeSH Terms

Conditions

BursitisMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Derya Çelik

    Istanbul University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

January 16, 2022

First Posted

January 28, 2022

Study Start

April 25, 2022

Primary Completion

June 1, 2023

Study Completion

July 20, 2023

Last Updated

July 24, 2023

Record last verified: 2023-07

Locations

TU(1)