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Completed

NCT Number: NCT04715035

Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder

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.

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Key information

Conditions

Frozen Shoulder Bursitis Capsulitis of Shoulder Capsulitis, Adhesive Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Durand Hospital

Buenos Aires, Buenos Aires City, 1405, Argentina

About this study

A randomized controlled clinical trial with two parallel groups will be carried out. Evaluators will be blinded to the treatment group and therapists will be unique to each group. This study will follow the CONSORT guidelines.

Randomization by blocks between groups will be carried out through the website www.randomization.com and the sequence will be stored in sealed and opaque envelopes to maintain allocation confidentiality. This process will be carried out by an independent researcher, who will not be involved in the assessment and treatment. The allocation of subjects will be revealed to the researcher responsible for the treatment by opening the envelope before the start of the intervention. The researcher responsible for the evaluation will be blinded to the treatment group. The individuals will be blinded in relation to the study hypothesis and will not have contact with the participants of the same or the other group.

Initially, all participants will undergo screening to assess the inclusion and non-inclusion criteria of the study. All individuals who meet the eligibility criteria will undergo an anamnesis to collect personal, sociodemographic, pain history, and primary and secondary outcomes measurements.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Physical therapy interventions

Other

mobilization, stretch, education, eccentric exercises

Primary outcomes

  1. Shoulder Function

    Time frame: 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.

    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.

Secondary outcomes

  1. Range of Movement

    Time frame: 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.

    An inclinometer will assess flexion, external rotation, and internal rotation range of movement. The higher the value, the better.

  2. Perceived Pain

    Time frame: 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.

    The perceived pain is going to be assessed by a Visual Analogue Scale from 0 to 10, where the score close to 0 is worst, and approximate to 10 is better.

  3. Pennation Angle

    Time frame: 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.

    It is going to be assessed by an ultrasound device

  4. Fear avoidance

    Time frame: 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 Beliefs Questionnaire This scale has a score between 0 to 96. When the score is more close to 96 worst is the fear avoidance and when is approximate to 0, it is better.

  5. Perceived Quality of life

    Time frame: 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.

    European Quality of Life Scale of five domains (EQ5D-3L). This scale has five items with a score between 1 to 3. When the score is more close to 3 worst is the quality of life and when is approximate to 1, it is better in each item. Also has a visual analogue scale of 100 points to assess the health condition, when the score is more close to 0 worst is the quality of life and when is approximate to 100 it is better.

  6. Muscle Thickness

    Time frame: 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.

    It is going to be assessed by an ultrasound device

  7. Pain Catastrophizing

    Time frame: 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.

    Pain Catastrophizing Scale (PCS)

Sponsors and collaborators

Lead sponsor

Hospital Durand, Argentina

Other

Registry information

Official study title

Efficacy of Eccentric Exercises in Individuals With Frozen Shoulder: A Randomized Controlled Clinical Trial

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2021
Registry last updated
Jul 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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