The Impact of Shoulder Mobilization-with-Movement Based on the Mulligan Concept on Inferior Shoulder Capsule Thickness and Motor Cortex Excitability in the Frozen Stage of Idiopathic Frozen Shoulder: A Randomized Clinical Trial

Evaluation of the impact of Shoulder MWM based on the Mulligan concept on inferior shoulder capsule thickness, motor cortex excitability, and functional performance in individuals with idiopathic frozen shoulder in the frozen stage.

Three arm parallel group randomized clinical trial with outcome assessor blinding

This study will be conducted at the Neuromuscular Rehabilitation Research Center of Semnan University of Medical Sciences.

Inclusion criteria: age 40–60, gradual progressive shoulder pain 3–6 months, pain at end-range motion, NPR Scale 4–6, confirmed idiopathic frozen shoulder (frozen stage), passive external rotation <30°. Exclusion criteria: systemic diseases, other shoulder musculoskeletal disorders, contraindications to TMS, physiotherapy or corticosteroid injection in past 6 months, medications affecting cortical excitability, caffeine within 24 hours.

The healthy control group includes individuals without frozen shoulder or shoulder pain and will not receive any intervention, serving only for baseline neurophysiological comparison. The other two groups comprise patients with idiopathic frozen shoulder (frozen stage), all receiving routine physiotherapy (ultrasound and TENS) for four weeks, three sessions per week. The intervention group additionally undergoes Mulligan shoulder mobilization-with-movement techniques—posterior–lateral–inferior, anterior–lateral–inferior, and internal–external rotation—in a seated position, three sets of 10 pain-free repetitions per technique, 30 seconds rest between sets, each repetition lasting ~6 seconds.

Inferior Glenohumeral Capsule Thickness

In this study, to ensure allocation concealment, permuted block randomization will be used in conjunction with sequentially numbered, opaque, sealed envelopes.

In this clinical trial, the outcome assessor will be blinded to both the participants’ health status and the type of treatment they receive, and all assessments will be conducted in a blinded manner.

All individual participant data will be de-identified (anonymized) prior to sharing. If ethical restrictions apply, at minimum, data on primary and secondary outcomes—including capsule thickness, range of motion, SPADI scores, and motor cortex excitability measures—will be made available.

Access period begins 6 months after publication of the results.

Data and study-related documents will be made available upon reasonable request to qualified researchers. Eligible applicants include researchers affiliated with academic and scientific institutions, and, provided that a clear research purpose and compliance with ethical and data confidentiality requirements are demonstrated, researchers from industry settings may also apply. All requests will be reviewed and approved by the study research team.

Access to de-identified individual participant data and other study-related documents will be granted upon submission of a formal written request outlining the research objectives, proposed analyses, and intended duration of data use. The data may be used solely for scientific and research purposes, including secondary analyses or meta-analyses, and any direct commercial use, attempts at participant re-identification, or sharing with third parties without written permission are prohibited. Applicants must adhere to all ethical, legal, and data confidentiality requirements, and provide appropriate citation of the original study in any resulting publications. All requests will be reviewed and approved by the study research team.

Eligible applicants seeking access to de-identified data or other study-related documents should submit a formal request primarily via email to the principal investigator, with postal correspondence available if needed. Contact details—including the principal investigator’s name, institutional affiliation, email address, telephone number, and postal address—are provided in the study information. Requests should specify the intended use of the data, proposed analyses, and the applicant’s contact information, and will be reviewed and responded to following approval by the study research team.

After receiving a formal request, it will first be reviewed by the principal investigator to assess completeness, research purpose, and compliance with ethical requirements. If necessary, additional information may be requested from the applicant. Following this initial review, the request will be discussed within the research team and a final decision regarding data access will be made. Upon approval, the requested data and documents will be provided in a de-identified format through a secure electronic platform. This process typically takes 2 to 4 weeks from receipt of a complete request, and applicants will be informed of the status of their request throughout the review period.