Physical therapy for the treatment of frozen shoulder: A protocol for systematic review of randomized controlled trial.

BACKGROUND: Previous clinical trials have reported that physical therapy (PT) can be used for the treatment of frozen shoulder (FS). However, its effectiveness is still inconclusive. In this systematic review study, we will aim to evaluate the effectiveness and safety of PT alone for the treatment of FS.
METHODS: The following electronic databases will be searched from the inception to the present to identify any eligible studies focusing on PT for the treatment of FS. These databases comprise of Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, and 4 Chinese databases of Chinese Biomedical Literature Database, China National Knowledge Infrastructure (which includes the database China Academic Journals), VIP Information, and Wanfang Data. All randomized controlled trials (RCTs) of PT for FS will be considered for inclusion without language restrictions. Cochrane risk of bias tool will be used to assess the methodological quality for all included RCTs.
RESULTS: The effectiveness and safety of this study will be assessed by shoulder pain intensity, shoulder function, quality of life, and any adverse events.
CONCLUSION: The findings of this study may provide most recent evidence on the effectiveness and safety of PT for patients with FS.

Introduction

Frozen shoulder (FS), also known as adhesive capsulitis, is a very common painful shoulder disorder.[ It has been reported that about 2% to 5% general population experience this condition, and it is also one of the most serious painful disorders in the musculoskeletal system.[ Patient who experience this condition often suffer from poor quality of life because of the restriction of the both active and passive range of their shoulder mobility.[ Although its etiology is still poorly understood, it is often regarded as the primary or secondary to the several diseases, such as diabetes mellitus, stroke, local shoulder issues, and any others.[

Physical therapy (PT) consists of 3 phrases of freezing, frozen, and thawing.[ It has been reported to treat FS effectively.[ A variety of clinical trials have assessed its effectiveness and safety for FS.[ Most of those studies utilized the combination of PT with other treatments for treating FS, and achieved satisfied effectiveness.[ However, no study has conducted a systematic review and meta-analysis to assess the effectiveness and safety of PT alone for the treatment of FS. Thus, in this systematic review, we will firstly investigate the effectiveness and safety of PT alone for the treatment of patient with FS.

Methods

Objective

This systematic review will aim to assess the effectiveness and safety of PT for the treatment of patients with FS.

Inclusion criteria for study selection

Type of studies

This study will only include randomized controlled trials (RCTs) of PT for patients with FS without any language restrictions. Any other studies, such as review, animal studies, case reports, case series, letters, comments, non-clinical trials, non-RCTs, and quasi-RCTs studies will all be excluded.

Type of participants

Patients with FS alone, regarding sex, and ages will be included.

Type of interventions

Intervention of any type of PT (includes 3 stages as freezing, frozen, and thawing) alone will be included. However, the combination of physical therapy with any other interventions will be excluded.

Control intervention can be any kinds of therapies, except PT.

Type of outcome measurements

Primary outcome is shoulder pain intensity, which is measured by any pain scales. The secondary outcomes include shoulder function, as assessed by Shoulder Pain and Disability Index; and quality of life, as measured by 36-Item Short Form Survey or any other related scales. In addition, any adverse events are also evaluated.

Search strategy

We will retrieve the following 9 electronic databases from the inception up to the present to identify any potential RCTs on PT for the treatment of FS. These databases include Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE, the Cumulative Index to Nursing and Allied Health Literature, the Allied and Complementary Medicine Database, and 4 Chinese databases of Chinese Biomedical Literature Database, China National Knowledge Infrastructure (which includes the database China Academic Journals), VIP Information, and Wanfang Data. The search terms include “adhesive capsulitis,” “adhesive,” “capsulitis,” “frozen shoulder,” “bursitis,”“bursitis,” “frozen,” “shoulder,” “physical therapy modalities,” “physical,” “therapy,” “modalities,” “physical therapy,”, “randomized controlled trial,”“controlled clinical trial,” “randomly,” “randomized,” and “trial.” The search strategy details for MEDLINE are presented in Table 1. The similar strategies will be applied to the other electronic databases. It will be translated into Chinese, and will be used to 4 Chinese databases. In addition, the website of clinical registry and bibliographic references in relevant publications will also be searched in order to avoiding missing any other eligible RCTs.

Table 1

Search strategy applied in MEDLINE database.

Study selection and data exaction

Study selection

Two review researchers will independently select all literatures by screening titles and abstracts based on the predefined eligibility criteria. All potential eligible studies will be further assessed by reading the full texts. All selection procedures will follow the PRISMA flow chart. If disagreements will occur between 2 researchers, then a third researcher will be invited to solve them via discussion.

Data extraction and management

If eligible studies are included, 2 review researchers will independently extract data by using a predefined standard data extraction form. It mainly includes general information, such as author, published year, country, study design, sample size; intervention; and outcomes; as well as the adverse events. All disagreements regarding the data extraction will be handled by discussion with a third researcher involved.

Quality assessment

Cochrane tool with risk of bias will be utilized to assess the quality of included studies by 2 independent review researchers. This tool consists of 7 domains. Each domain is presented as high, unclear, and low risk of biases, respectively. Any disagreements will be solved by a third review researcher joining in through discussion.

Statistical analysis

Continuous data are presented as the mean difference or standardized mean difference with 95% confidence intervals (CIs), while the dichotomous data are presented with the risk ratio with 95% CIs.

The test of I2 will be utilized to identify the heterogeneity. A value of I2 ≤ 50% is set as having homogeneous, and the data will be pooled by a fixed-effect model if eligible studies are included. In addition, meta-analysis will be conducted if >2 eligible RCTs are included. Otherwise, a value of I2 > 50% is regarded as having substantial heterogeneity. Under such situation, a random-effect model will be used, and subgroup analysis will be conducted to check any possible reasons that may cause substantial heterogeneity based on the different treatments, controls, and outcome measurements. After subgroup analysis, if the heterogeneity is still significant, a narrative summary will be presented instead of data pooled and meta-analysis.

Additionally, sensitivity analysis will also be performed to check the robustness of the pooled results depends on the different methodological qualities, and statistical models. Furthermore, funnel plot and Begger test will also be carried out to identify any reporting bias if sufficient eligible studies are included in this study.

Discussion

This systematic review will conduct a comprehensive literature search to assess the effectiveness and safety of PT for patient with FS. We will search either electronic literature databases or grey literature sources to avoid missing any potential eligible studies. The results of this study will summarize the latest evidence on assessing the effectiveness and safety of PT for patients with FS. It may benefit both clinicians and patients.

Author contributions

Conceptualization: Hua-yu Tang, Wei Wei, Yu Zhao.

Data curation: Hua-yu Tang, Wei Wei, Tao Yu, Yu Zhao.

Formal analysis: Hua-yu Tang, Tao Yu.

Funding acquisition: Tao Yu, Yu Zhao.

Investigation: Wei Wei, Yu Zhao.

Methodology: Hua-yu Tang, Wei Wei, Tao Yu.

Project administration: Yu Zhao.

Resources: Hua-yu Tang, Wei Wei, Tao Yu, Yu Zhao.

Software: Hua-yu Tang, Wei Wei, Tao Yu.

Supervision: Yu Zhao.

Validation: Hua-yu Tang, Wei Wei, Yu Zhao.

Visualization: Hua-yu Tang, Wei Wei, Tao Yu, Yu Zhao.

Writing – original draft: Hua-yu Tang, Tao Yu, Yu Zhao.

Writing – review & editing: Hua-yu Tang, Wei Wei, Tao Yu, Yu Zhao.