Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder

NCT04715035 | Completed

• 1 other identifier: Policastro.ECA.HombroCongelado
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Frozen shoulder is a musculoskeletal condition with a strong negative impact on activities of daily living, producing pain, disability, anxiety, and sleep disorders. It has a worldwide prevalence of 5.3%, increasing from 10 to 38% in patients with diabetes and thyroid conditions. This clinical entity manifests itself mainly in women between 40 and 65 years of age. Its resolution time is long and can reach 42 months with symptoms that persist throughout life. In the clinical evaluation, patients with Frozen Shoulder are manifested mainly by presenting mobility deficits. Previous studies described different structural alterations that may justify this clinical condition and its consequences, such as, for example, fibrosis of the coracohumeral ligament, alterations of the rotator interval, and of the axillary recess. Although passive structures are believed to be primarily involved in this condition, A series of five cases in which patients with frozen shoulder presented a significant increase in mobility after a general anesthetic block. The data obtained from this study and the different complications presented by patients with CH suggest that it is necessary to further understand the role of the rotator cuff in this clinical condition. Eccentric exercises consist of contracting the muscle to control or decelerate a load while the muscle or tendon is lengthening or remaining stretched. This intervention has been proposed for the treatment of tendinopathies in different body regions.

Conditions

Frozen Shoulder; Capsulitis, Adhesive; Capsulitis of Shoulder

Keywords

frozen shoulder; eccentric exercise; rehabilitation; physical therapy

Outcome Measures

Primary Outcomes (1)

• Shoulder Function

  American Shoulder and Elbow Surgeons scale (ASES). This scale has a score between 0 to 100. When the score is more close to 0 Worst is the function of the shoulder and when is approximate 100, it is better.

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

Secondary Outcomes (7)

• Range of Movement

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

• Perceived Pain

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

• Pennation Angle

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

• Fear avoidance

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

• Perceived Quality of life

  From enrollment to the end of treatment at 12 weeks. In the follow-up at 3 months and 9 months from the end of treatment.

Study Arms (2)

Conventional treatment

ACTIVE COMPARATOR

Physical therapy: education, mobilizations, stretch, active exercises, home excercises.

Other: Physical therapy interventions

Conventional treatment + eccentric exercises

EXPERIMENTAL

Physical therapy: education, mobilizations, stretch, active exercises, home exercises, eccentric exercises.

Other: Physical therapy interventions

Interventions

Physical therapy interventions OTHER

mobilization, stretch, education, eccentric exercises

Conventional treatment; Conventional treatment + eccentric exercises

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• History of diffuse-onset shoulder pain of at least one month
• Gradual loss of passive external rotation of at least 50% compared to the contralateral side

You may not qualify if:

• \- History of shoulder fracture/ surgery
• Shoulder pain reproduced by passive movement of the cervical spine
• History of rheumatoid arthritis
• Shoulder immobilization for more than 5 days
• Bilateral frozen shoulder

Sponsors & Collaborators

• Hospital Durand, Argentina: lead

Study Sites (1)

Durand Hospital

Buenos Aires, Buenos Aires City, 1405, Argentina

Location

Related Publications (1)

• 1. Ryan V, Brown H, Minns Lowe CJ, Lewis JS. The pathophysiology associated with primary (idiopathic) frozen shoulder: A systematic review. BMC Musculoskelet Disord. 2016 Aug 15;17(1):340. 2. 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. 3. Lewis J. Frozen shoulder contracture syndrome - Aetiology, diagnosis and management. Man Ther. 2015 Feb;20(1):2-9. 4. Chan HBY, Pua PY, How CH. Physical therapy in the management of frozen shoulder. Singapore Med J. 2017 Dec;58(12):685-689. 5. 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. 6. Hollmann L, Halaki M, Kamper SJ, Haber M, Ginn KA. Does muscle guarding play a role in range of motion loss in patients with frozen shoulder? Musculoskelet Sci Pract. 2018 Oct;37:64-68.

  BACKGROUND

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Study Officials

• Paula Camargo, PhD

  University of São Carlos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapy

Study Record Dates

• First Submitted: January 13, 2021
• First Posted: January 20, 2021
• Study Start: August 3, 2022
• Primary Completion: June 27, 2025
• Study Completion: June 27, 2025
• Last Updated: July 1, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

AR (1)