The Effect of Fascial Treatment in Patients With Adhesive Capsulitis

NCT ID: NCT07163884

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-15
• Study Completion Date: 2025-11-15

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.

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.

Conditions

Adhesive Capsulitis; Ultrasonography; Fascia; Treatment (ProudMe)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Fascial therapy 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.

Group Type: EXPERIMENTAL

Facsial therapy

Intervention Type: OTHER

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.

Control group

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.

Group Type: ACTIVE_COMPARATOR

electrotherapy treatment

Intervention Type: OTHER

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.

Interventions

electrotherapy 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.

Intervention Type: OTHER

Facsial therapy

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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,

Exclusion Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hasan Kalyoncu University

OTHER

Sponsor Role: lead

Responsible Party

Tuğba GÖNEN

Asisst. Prof. Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hasan Kalyoncu University

Gaziantep, Gaziantep, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Central Contacts

Tuğba GÖNEN, Asisst. Prof. Dr.

Role: CONTACT

tugba.badat@hku.edu.tr

505 090 58 46

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Other Identifiers

2025/111

Identifier Type: -

Identifier Source: org_study_id