A core outcome set for clinical trials of Frozen Shoulder

Frozen shoulder (FS) is one of the most common, yet challenging clinical disorder presenting to the Department of orthopedics and physical therapy, It is a disease characterized by a significant decrease of active and passive range of motion (ROM) of the glenohumeral joint along with pain. , seriously affecting quality of life in FS patients. At present, clinical treatment methods are diverse,Treatment modalities for FS include medication, local steroid injection, physiotherapy, hydrodistension, manipulation under anesthesia, arthroscopic capsular release, and open capsular release. However, due to the inconsistent clinical evaluation criteria for FS, lack of practicality, the remission rates of different therapies vary greatly, and the best treatment plan cannot be selected. Therefore, a series of accurate and effective assessment method(s) is needed, and it is necessary to establish a core outcome set (COS) for clinical trials of FS.


Organisation:Acupuncture Department, First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine,Acupuncture and Massage Department, Qingyang Hospital of Traditional Chinese Medicine,
Principal investigator: Yang Bai

Further Study Information

Current Stage: Ongoing
Date: January 2020 - January 2022
Funding source(s): To be confirmed

Health Area

Disease Category: Orthopaedics & trauma

Disease Name: Frozen shoulder

Target Population

Age Range: 40 - 70

Sex: Either

Nature of Intervention: Drug, Non-surgical, Physiotherapy

Stakeholders Involved

- Clinical experts
- Conference participants
- Consumers (patients)
- Methodologists
- Patient/ support group representatives
- Researchers

Study Type

- COS for clinical trials or clinical research
- COS for practice


- Consensus meeting
- Delphi process
- Systematic review

First, search all date bases for all interventions for breast cancer-associated frozen shoulder and develop a plan and publish it, then take all the results, systematically evaluate them, and then meet with clinical experts and patient representatives to set up a core outcome set.

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