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IRCT20251221068399N1 IRCT 2025-12-26 Semnan University of Medical Sciences The Impact of Shoulder Joint Mobilization in Patients with Idiopathic Frozen Shoulder: A Randomized Clinical Trial 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 2026-01-20 anticipated 45 Recruiting https://irct.ir/trial/88236 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, to ensure allocation concealment, permuted block randomization will be used in conjunction with sequentially numbered, opaque, sealed envelopes, Blinding description: 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. N/A Frozen Shoulder. Intervention 1: Control group: healthy control group. Intervention 2: Intervention group: Intervention Group 1 (Patient Control). Intervention 3: Intervention group: Intervention Group 2. Yes - There is a plan to make this available What will be shared: 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. When: Access period begins 6 months after publication of the results. To whom: 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. Conditions: 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. Where to obtain: 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. How to obtain: 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. Comments:
public Ali Khandaloo
Basij Blvd
Semnan Iran (Islamic Republic of) 3518815359 +98 23 3330 0397 alikhandaloo1997@gmail.com Semnan University of Medical Sciences scientific Ali Khandaloo
Hakim Elahi Blvd
Semnan Iran (Islamic Republic of) 3518815359 +98 23 3330 0397 alikhandaloo1997@gmail.com Semnan University of Medical Sciences Iran (Islamic Republic of) Being 40–60 years of age; experiencing gradual and progressive shoulder pain over the past 3–6 months; reporting pain at the end ranges of shoulder motion; having a Numeric Pain Rating Scale score between 4 and 6; presenting with a confirmed diagnosis of idiopathic frozen shoulder in the frozen stage; and demonstrating passive external rotation restricted to less than 30 degrees. 40 years 60 years Both The presence of systemic diseases; coexisting musculoskeletal disorders of the shoulder; any contraindications to transcranial magnetic stimulation; a history of physiotherapy or corticosteroid injections within the preceding six months; use of medications known to influence cortical excitability; and consumption of caffeine within 24 hours prior to the assessments. M75.0 Adhesive capsulitis of shoulder Other Rehabilitation Rehabilitation Control group: healthy control group Intervention group: Intervention Group 1 (Patient Control) Intervention group: Intervention Group 2 Inferior Glenohumeral Capsule Thickness. Timepoint: Before treatment, immediately after treatment, and two months after treatment. Method of measurement: Ultrasound Imaging. Motor Cortex Excitability. Timepoint: Before treatment, immediately after treatment, and two months after treatment. Method of measurement: Transcranial Magnetic Stimulation. Shoulder Cardinal Range of Motion. Timepoint: Before treatment, immediately after treatment, and two months after treatment. Method of measurement: Goniometer. Shoulder Functional Performance. Timepoint: Before treatment, immediately after treatment, and two months after treatment. Method of measurement: Shoulder Pain and Disability Index (SPADI questionnaire). Semnan University of Medical Sciences Approved 2025-12-21 Ethics Committee of Semnan University of Medical Sciences and Health Services Basij Blvd Semnan Semnan Iran (Islamic Republic of)