NCT07163884

Brief Summary

Our study is unique in that it utilizes a self-designed fascial mobilization protocol and ultrasonographic evaluation for adhesive capsulitis. Therefore, the aim of our study is to investigate the effects of fascial therapy on pain, normal joint range of motion, proprioception, and fascial architecture in patients diagnosed 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
36

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

September 1, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed
6 days until next milestone

Study Start

First participant enrolled

September 15, 2025

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

September 9, 2025

Status Verified

September 1, 2025

Enrollment Period

1 month

First QC Date

September 1, 2025

Last Update Submit

September 1, 2025

Conditions

Keywords

adhezsiv capsulitispainrange of motionproprioceptionfascia architecture

Outcome Measures

Primary Outcomes (4)

  • Ultrasonographic Measurement

    An ultrasound (measured by 7.5-10 MHz mobile ultrasound (ALEXUS A10HRL) device will be used to evaluate fascial architecture. The thickness and density of the coracohumeral ligament, supraspinatus tendon, infraspinatus tendon, long head of the biceps, and deltoid fascia, which constitute the patients' shoulder and fascial architecture and are among the structures most affected by adhesive capsulitis, will be evaluated.

    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

  • Proprioception

    Individuals shoulder proprioception will be measured with a laser pointer. A laser pointer is attached to the patient's arm, and the shoulder is flexed 90 degrees, and the laser reflection is marked on the wall. The patient is then asked to close their eyes and maintain the same degree of flexion. The laser reflection is marked. The distance between the two distances is recorded in centimeters. A greater deviation between the two distances indicates a greater loss of proprioception.

    through of the study, average 3 weeks

Secondary Outcomes (1)

  • Upper extremity functionality

    through of the study, average 3 weeks

Study Arms (2)

Fascial therapy group

EXPERIMENTAL

In addition to electrotherapy, the patients in the study group will receive a total of five sessions (one day per week for five weeks) of fascial therapy. The protocol will be developed by us. Fascial mobilization will be performed by a trained physiotherapist on the pectoral fascia, deltoid fascia, axillary fascia, and supscapularis fascia, once a week, for 180 seconds each repetition. These sessions will be performed at the pain threshold, and care will be taken to ensure that the pain does not exceed a VAS score of 2.

Other: Facsial therapy

Control group

ACTIVE COMPARATOR

Patients will receive 15 sessions of electrotherapy. A 15-minute hotpack will be applied, followed by a 20-minute TENS application, and then a 6-minute deep heating (1.5 Hz ultrasound) will be applied. Pre-treatment assessments will be repeated after treatment.

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 a total of five sessions (one day per week for five weeks) of fascial therapy. The protocol will be developed by us. Fascial mobilization will be performed by a trained physiotherapist on the pectoral fascia, deltoid fascia, axillary fascia, and supscapularis fascia, once a week, for 180 seconds each repetition. These sessions will be performed at the pain threshold, and care will be taken to ensure that the pain does not exceed a VAS score of 2.

Fascial therapy group

Eligibility Criteria

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

You may qualify if:

  • Patients diagnosed with adhesive capsulitis by a specialist,
  • Patients between the ages of 35 and 60,
  • Those not diagnosed with cervical disc herniation that could cause other shoulder pathologies,
  • Those who have not participated in an upper extremity-related physiotherapy program within the last 6 months,
  • Individuals who volunteer 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 (11)

  • Ager AL, Roy JS, Roos M, Belley AF, Cools A, Hebert LJ. Shoulder proprioception: How is it measured and is it reliable? A systematic review. J Hand Ther. 2017 Apr-Jun;30(2):221-231. doi: 10.1016/j.jht.2017.05.003.

    PMID: 28641738BACKGROUND
  • 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
  • Aggarwal A, Saxena K, Palekar TJ, Rathi M. Instrument assisted soft tissue mobilization in adhesive capsulitis: A randomized clinical trial. J Bodyw Mov Ther. 2021 Apr;26:435-442. doi: 10.1016/j.jbmt.2020.12.039. Epub 2020 Dec 31.

    PMID: 33992280BACKGROUND
  • 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
  • Al Khayyat SG, Falsetti P, Conticini E, Frediani B, Galletti S, Stella SM. Adhesive capsulitis and ultrasound diagnosis, an inseparable pair: a novel review. J Ultrasound. 2023 Jun;26(2):369-384. doi: 10.1007/s40477-022-00725-9. Epub 2022 Oct 25.

    PMID: 36284048BACKGROUND
  • Wong KK, Chai HM, Chen YJ, Wang CL, Shau YW, Wang SF. Mechanical deformation of posterior thoracolumbar fascia after myofascial release in healthy men: A study of dynamic ultrasound imaging. Musculoskelet Sci Pract. 2017 Feb;27:124-130. doi: 10.1016/j.math.2016.10.011. Epub 2016 Oct 25.

    PMID: 27847243BACKGROUND
  • Kirker K, O'Connell M, Bradley L, Torres-Panchame RE, Masaracchio M. Manual therapy and exercise for adhesive capsulitis: a systematic review with meta-analysis. J Man Manip Ther. 2023 Oct;31(5):311-327. doi: 10.1080/10669817.2023.2180702. Epub 2023 Mar 2.

    PMID: 36861780BACKGROUND
  • Nakandala P, Nanayakkara I, Wadugodapitiya S, Gawarammana I. The efficacy of physiotherapy interventions in the treatment of adhesive capsulitis: A systematic review. J Back Musculoskelet Rehabil. 2021;34(2):195-205. doi: 10.3233/BMR-200186.

    PMID: 33185587BACKGROUND
  • 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

BursitisPain

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

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 fascia therapy. The other group will receive electrotherapy.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asisst. Prof. Dr.

Study Record Dates

First Submitted

September 1, 2025

First Posted

September 9, 2025

Study Start

September 15, 2025

Primary Completion

October 15, 2025

Study Completion

November 15, 2025

Last Updated

September 9, 2025

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations