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Not yet recruitingNCT07158255Updated Sep 5, 2025

Effects of Exercise on Adhesive Capsulitis

An interventional study of electrotherapy treatment and Exercise training in Adhesive Capsulitis, Exercise and Ultrasonography, sponsored by Hasan Kalyoncu University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2025-09-05.

Sponsored by Hasan Kalyoncu University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Oct 2025, 11 months ago, but the record still lists the study as not yet recruiting.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

Read the detailed description

Adhesive capsulitis (AC) is a common shoulder condition characterized by a gradual increase in spontaneous pain and a limitation in glenohumeral joint range of motion. Its pathophysiology, a pathological process of capsular fibrosis following synovial inflammation, is relatively well understood, but its cause remains unknown. The literature on the treatment of frozen shoulder, whose etiology remains unknown, provides evidence of the effectiveness of conservative treatment approaches such as physiotherapy, analgesics, and steroid injections. Early treatment success is achieved through pain reduction and increased function rather than achieving full range of motion. Pain with movement is minimal in primary frozen shoulder in Stage 1, while night pain accompanied by activity pain is also observed in Stages 2 and 3. Secondary frozen shoulder presents with similar pain, primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without pain suppression is quite difficult in patients with frozen shoulder. Although heat or electrotherapy methods are accepted to have theoretically positive effects on pain in treatment, it is difficult to determine the effect of a single method on the natural course of the disease. For this reason, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. Thermal tools and stretching exercises are frequently used in physiotherapy to maintain and regain flexibility. Ultrasonography, which is among the clinical diagnostic methods performed in patients with adhesive capsulitis, has shown increased thickness, especially in the coracohumeral ligament, followed by fibrous changes in the supraspinatus tendon and long head of the biceps. The effectiveness of exercise training combined with electrotherapy on many factors has been frequently investigated in the literature. However, a review of the literature did not find any studies on the effects of exercise training given in adhesive capsulitis on shoulder architecture. The fact that ultrasonographic examination, an indispensable part of the diagnosis and treatment process, provides objective data on the effects of exercise will increase the quality of the study. In this context, our study; The aim of this study is to investigate the effects of exercise training on pain, range of motion, functionality and shoulder architecture in patients with adhesive capsulitis.

02

Conditions studied

  • Adhesive Capsulitis
  • Exercise
  • Ultrasonography

Keywords

  • adhezsiv capsulitis
  • pain
  • range of motion
  • functionality
  • shoulder architecture
  • exercise
03

In context

Bursitis

411 studies on the registry are indexed under Bursitis; 112 are open to participants now.

This study's planned enrollment of 32 is below the median of 45 across 371 interventional studies indexed under Bursitis.

Browse Bursitis studies →

Lead sponsor

Hasan Kalyoncu University is the lead sponsor of 161 studies on the registry; 32 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Individuals who have undergone shoulder surgery consistent with any pathology,
  • Individuals with a neurological history,
  • Individuals diagnosed with diabetes mellitus (DM)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Exercise training group

    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

  • Active comparator
    Control group

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

    Other: electrotherapy treatment

Interventions

  • Otherelectrotherapy treatment

    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.

  • OtherExercise training

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: through of the study, average 3 weeks

  2. 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.

    Time frame: through of the study, average 3 weeks

  3. 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.

    Time frame: through of the study, average 3 weeks

  4. 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.

    Time frame: through of the study, average 3 weeks

Secondary outcomes

  1. Kinesiophobia

    The Tampa Kinesiophobia Scale will be used to assess the fear of movement and movement avoidance in individuals diagnosed with adhesive capsulitis. The survey, whose validity and reliability study was conducted by Yılmaz et al. in 2011, consists of 17 descriptive questions. Each question uses a 4-point Likert-type scoring system (1=Strongly disagree, 2=Agree, 3=Disagree, 4=Strongly agree). Based on the responses, the individual receives a total score between 17 and 68. A high score on the scale indicates a high degree of kinesiophobia.

    Time frame: through of the study, average 3 weeks

  2. The quality of Life

    The European General Quality of Life Scale (EQ-5D) will be used to assess patients' quality of life. The EQ-5D general quality of life scale was developed in 1987 by the EuroQol group, the Western European Society for the Study of Quality of Life, and consists of two sections. The first section describes the current health profile in five subdimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Responses for each section have five options: "no problem," "mild problem," "moderate problem," "severe problem," and "extreme problem." The second section consists of a visual analog scale (VAS). In this section, individuals rate their current health status on a scale resembling a thermometer. Quality of life scores ranging from 0 to 100 are obtained from the visual analog scale. As the scale score increases, the perception of health increases in a positive direction.

    Time frame: through of the study, average 3 weeks

07

Study locations

1 site
  • Hasan Kalyoncu University
    Gaziantep, Gaziantep (505) 090-5846, Turkey (Türkiye)
08

References and documents

Publications

  • 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. PubMed 17106618 ↗
  • 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. PubMed 33997079 ↗
  • 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. PubMed 40443485 ↗
  • 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. PubMed 39479361 ↗
  • 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. PubMed 22814453 ↗
  • 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. PubMed 23636125 ↗
  • 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. PubMed 19194024 ↗
  • 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. PubMed 21167743 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07158255
Lead sponsor
Hasan Kalyoncu University
Responsible party
Tuğba GÖNEN (Assist. Prof. Dr., Hasan Kalyoncu University) — Principal investigator
First posted
Sep 5, 2025
Start date
Sep 5, 2025 (estimated)
Primary completion
Oct 30, 2025 (estimated)
Completion
Nov 15, 2025 (estimated)
Last update
Sep 5, 2025

Study contacts

Tuğba GÖNEN, Asisst. Prof. Dr.
Contact
tugba.badat@hku.edu.tr
505 090 58 46

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.

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