The Effect of Fascial Treatment in Patients With Adhesive Capsulitis

Official title

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

Overview

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.

Interventions

• Other 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.
• 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 no

Primary outcome measures

• Ultrasonographic Measurement [Time frame: through of the study, average 3 weeks]
• The pain [Time frame: through of the study, average 3 weeks]
• Range of Motion [Time frame: through of the study, average 3 weeks]
• Proprioception [Time frame: through of the study, average 3 weeks]

Secondary outcome measures (1)

• Upper extremity functionality [Time frame: through of the study, average 3 weeks]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Turkey (Türkiye) · 1 center

• Hasan Kalyoncu University — Gaziantep

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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 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. PMID 33185587

Identifiers

NCT: NCT07163884 · 2025/111

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗