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Adhesive CapsulitisNCT07163884

The Effect of Fascial Treatment in Patients With Adhesive Capsulitis

A study testing electrotherapy treatment and Facsial therapy in people with Adhesive Capsulitis and Ultrasonography, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 35 to 65 years
Conditions the study is for
Adhesive Capsulitis, Ultrasonography, Fascia
What is being tested?
electrotherapy treatment and Facsial therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
1 siteTurkey (Türkiye)
Study dates
15 Sep 2025to 15 Nov 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 35 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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,

Who cannot join

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Tuğba GÖNEN, Asisst. Prof. Dr. contact

505 090 58 46

tugba.badat@hku.edu.tr

Turkey (Türkiye)1 site
  • Hasan Kalyoncu University

    Gaziantep, Gaziantep, (505) 090-5846

Other trials in Turkey (Türkiye)

About this study

Official title: Adheziv kapsülit tanılı Hastalarda Fasyal Tedavinin ağrı, Normal Eklem Hareket açıklığı, Propriosepsiyon ve Fasya Mimarisine Etkisinin araştırılması

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.

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 (1). Pain with movement is minimal in Stage 1 of primary frozen shoulder, while night pain accompanied by activity pain is observed in Stages 2 and 3. Similar pain is observed in secondary frozen shoulder, and the pain is primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without suppressing pain in patients with frozen shoulder is quite challenging. While heat or electrotherapy are theoretically considered to have positive effects on pain in their treatment, it is difficult to determine the impact of a single method on the natural course of the disease. Therefore, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises. (2) Pain with movement is minimal in Stage 1 of primary frozen shoulder, while night pain accompanying activity pain is observed in Stages 2 and 3. Similar pain is observed in secondary frozen shoulder, and the pain is primarily caused by inflammation in the shoulder joint capsule. Increasing range of motion without suppressing pain is quite difficult in patients with frozen shoulder. While heat or electrotherapy are considered 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. Therefore, therapeutic methods are generally applied in addition to manual therapy and therapeutic exercises (3). Studies have suggested the effectiveness of these treatment methods, but sufficient data on the effectiveness of these methods are not yet available (4). Manual therapy methods have begun to be used in adhesive capsulitis, but a meta-analysis has not yet determined the optimal treatment dose (5). Fascia therapy has recently become increasingly used, particularly for lumbar spine pathologies. However, no studies were found on shoulder fascia (6). Ultrasonography is a diagnostic method used in patients with adhesive capsulitis. Ultrasonographic evaluation studies have observed increased coracohumeral ligament thickness, increased supraspinatus tendon thickness, and effusion. However, no ultrasonographic study demonstrating changes in shoulder architecture following physiotherapy interventions was found (7,8). No studies were found on fascial treatment; only one study used instrument-assisted soft tissue mobilization (9). Our study is unique in that it utilized a self-designed fascial mobilization protocol and was evaluated with ultrasonography in adhesive capsulitis. Therefore, the aim of our study was to investigate the effects of fascial treatment on pain, normal joint range of motion, proprioception, and fascial architecture in patients with adhesive capsulitis.

Being tested
electrotherapy treatment, Facsial therapy
Keywords
adhezsiv capsulitis, pain, range of motion, proprioception, fascia architecture
Medical subject headings
Bursitis, Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • electrotherapy treatmentOther

    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.

  • Facsial therapyOther

    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.

Study groups in NCT07163884
Study groupRoleWhat they receive
Fascial therapy groupExperimentalIn 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.
Receives: Other: Facsial therapy
Control groupActive comparatorPatients 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.
Receives: Other: electrotherapy treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 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.

    Measured: 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.

    Measured: through of the study, average 3 weeks

  4. 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.

    Measured: through of the study, average 3 weeks

Secondary outcomes (1)
  1. 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.

    Measured: through of the study, average 3 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2025
  2. Study start15 Sep 2025 (estimated)
  3. Primary completion15 Oct 2025 (estimated)
  4. Study completion15 Nov 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07163884
Sponsor's protocol ID
2025/111
Status last verified
Sep 2025
First submitted
1 Sep 2025
Last updated
9 Sep 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 28641738
  • 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
  • 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.

    PubMed 33992280
  • 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
  • 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.

    PubMed 36284048
  • 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.

    PubMed 27847243
  • 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.

    PubMed 36861780
  • 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.

    PubMed 33185587
  • 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

Questions about this trial

What is this clinical trial studying?

A study testing electrotherapy treatment and Facsial therapy in people with Adhesive Capsulitis and Ultrasonography, run by Hasan Kalyoncu University at 1 site in Turkey (Türkiye).

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Tuğba GÖNEN, Asisst. Prof. Dr. (505 090 58 46, tugba.badat@hku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Ultrasonographic Measurement (time frame: through of the study, average 3 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07163884, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.

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