NCT07158255

Brief Summary

Our study aims to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.

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
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 28, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 5, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

September 5, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2025

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

September 5, 2025

Status Verified

August 1, 2025

Enrollment Period

2 months

First QC Date

August 28, 2025

Last Update Submit

August 28, 2025

Conditions

Keywords

adhezsiv capsulitispainrange of motionfunctionalityshoulder architectureexercise

Outcome Measures

Primary Outcomes (4)

  • Ultrasonographic Measurement

    Thickness and density measurements of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of biceps and deltoid fascia, which constitute the shoulder architecture of the patients and are among the structures most affected by adhesive capsulitis, will be evaluated with an Ultrasound (Measured by 7.5-10 Mhz mobile ultrasound (ALEXUS A10HRL) device.

    through of the study, average 3 weeks

  • The pain

    Mc Gill Short Form will used to determine the type and severity of the pain. A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.

    through of the study, average 3 weeks

  • Range of Motion

    A Universal Goniometer will be used to assess normal range of motion. Measurements will be made regarding shoulder flexion, extension, abduction, adduction, internal and external rotation ranges of motion in three planes of the upper extremity shoulder joint, and the results will be recorded in degrees.

    through of the study, average 3 weeks

  • Upper extremity functionality

    The Questionnaire for Arm, Shoulder, and Hand Disabilities (Q-DASH) will be used to assess individuals' upper extremity functions. This questionnaire is a self-administered measurement tool with validated validity and reliability in Turkish. The validity and reliability of the Turkish version of the DASH questionnaire (DASH-T) was conducted in Turkey by Düger et al. in 2006. The questionnaire, consisting of 30 questions, assesses the individual's ability to perform functional activities (21 items), pain (5 items), and psychosocial aspects of the disease (4 items). The total score ranges from 0 to 100, with a higher score indicating better outcomes.

    through of the study, average 3 weeks

Secondary Outcomes (2)

  • Kinesiophobia

    through of the study, average 3 weeks

  • The quality of Life

    through of the study, average 3 weeks

Study Arms (2)

Exercise training group

EXPERIMENTAL

Patients in the study group will receive 15 sessions of exercise training (daily for 3 weeks). Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality.

Other: Exercise training

Control group

ACTIVE COMPARATOR

Patients in the control group will receive 15 sessions of electrotherapy treatment (TENS, US, Hotpack)

Other: electrotherapy treatment

Interventions

Patients in the electrotherapy group will receive 15 sessions of TENS, hotpack, and ultrasound, 45 minutes each, 5 days a week, for 3 weeks. The treatment program is planned for 20 minutes of TENS, 15 minutes of hotpack, and 10 minutes of ultrasound.

Control group

In addition to electrotherapy, the patients in the study group will receive 15 sessions (45 minutes, 5 days a week, for 3 weeks) of exercise training consistent with the literature. Exercise training includes programs to increase joint range of motion and mobility at the pain threshold and to restore functionality. Following electrotherapy, upper extremity normal range of motion exercises, anterior and posterior capsule stretching exercises, pendulum exercises, wand exercises, isometric training in 3 planes, and isotonic strengthening exercises will be applied. Five exercises will be selected each day, performed under the supervision of a physiotherapist. A 2-minute rest period will be provided after each exercise, followed by a transition to the next exercise. Care will be taken to perform the exercises within the pain threshold and to ensure that the pain does not exceed a VAS score of 2.

Exercise training group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Diagnosed with adhesive capsulitis by a physician,
  • Between the ages of 35-60,
  • Not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
  • Not participating in an upper extremity-related physiotherapy program within the last 6 months,
  • Volunteering individuals to participate in the study

You may not qualify if:

  • Individuals who have undergone shoulder surgery consistent with any pathology,
  • Individuals with a neurological history,
  • Individuals diagnosed with diabetes mellitus (DM)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hasan Kalyoncu University

Gaziantep, Gaziantep, (505) 090-5846, Turkey (Türkiye)

Location

Related Publications (8)

  • Yakut Y, Yakut E, Bayar K, Uygur F. Reliability and validity of the Turkish version short-form McGill pain questionnaire in patients with rheumatoid arthritis. Clin Rheumatol. 2007 Jul;26(7):1083-7. doi: 10.1007/s10067-006-0452-6. Epub 2006 Nov 15.

    PMID: 17106618BACKGROUND
  • Do JG, Hwang JT, Yoon KJ, Lee YT. Correlation of Ultrasound Findings With Clinical Stages and Impairment in Adhesive Capsulitis of the Shoulder. Orthop J Sports Med. 2021 May 10;9(5):23259671211003675. doi: 10.1177/23259671211003675. eCollection 2021 May.

    PMID: 33997079BACKGROUND
  • Liu J, Pan H, Bao Y, Huang L, Hu Y. The clinical utility of musculoskeletal ultrasonography in hemiplegic shoulder rehabilitation poststroke. Front Rehabil Sci. 2025 May 15;6:1576890. doi: 10.3389/fresc.2025.1576890. eCollection 2025.

    PMID: 40443485BACKGROUND
  • Moleesaide A, Saengsuwan J, Sirasaporn P. Musculoskeletal ultrasound of the shoulder in patients with adhesive capsulitis. Biomed Rep. 2024 Oct 11;21(6):190. doi: 10.3892/br.2024.1878. eCollection 2024 Dec.

    PMID: 39479361BACKGROUND
  • Nakano J, Yamabayashi C, Scott A, Reid WD. The effect of heat applied with stretch to increase range of motion: a systematic review. Phys Ther Sport. 2012 Aug;13(3):180-8. doi: 10.1016/j.ptsp.2011.11.003. Epub 2011 Dec 29.

    PMID: 22814453BACKGROUND
  • Kelley MJ, Shaffer MA, Kuhn JE, Michener LA, Seitz AL, Uhl TL, Godges JJ, McClure PW. Shoulder pain and mobility deficits: adhesive capsulitis. J Orthop Sports Phys Ther. 2013 May;43(5):A1-31. doi: 10.2519/jospt.2013.0302. Epub 2013 Apr 30. No abstract available.

    PMID: 23636125BACKGROUND
  • Kelley MJ, McClure PW, Leggin BG. Frozen shoulder: evidence and a proposed model guiding rehabilitation. J Orthop Sports Phys Ther. 2009 Feb;39(2):135-48. doi: 10.2519/jospt.2009.2916.

    PMID: 19194024BACKGROUND
  • Hsu JE, Anakwenze OA, Warrender WJ, Abboud JA. Current review of adhesive capsulitis. J Shoulder Elbow Surg. 2011 Apr;20(3):502-14. doi: 10.1016/j.jse.2010.08.023. Epub 2010 Dec 16. No abstract available.

    PMID: 21167743BACKGROUND

MeSH Terms

Conditions

BursitisMotor ActivityPain

Interventions

Exercise

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Tuğba GÖNEN, Asisst. Prof. Dr.

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were divided into two groups. Two different interventions were administered to each group. One group will receive electrotherapy and exercise therapy. The other group will receive electrotherapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assist. Prof. Dr.

Study Record Dates

First Submitted

August 28, 2025

First Posted

September 5, 2025

Study Start

September 5, 2025

Primary Completion

October 30, 2025

Study Completion

November 15, 2025

Last Updated

September 5, 2025

Record last verified: 2025-08

Data Sharing

IPD Sharing
Will not share

Locations