- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07704411
The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis
July 14, 2026 updated by: Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
The aim of this study was to evaluate the effects of adding osteopathic visceral manipulation (OVM) to a standard physical therapy program on pain, functional disability, and range of motion (ROM) in patients diagnosed with right shoulder adhesive capsulitis (AC).
A total of 49 patients aged between 40 and 65 years who were diagnosed with right shoulder AC were included in the study.
Randomized patients received a standard physical therapy program for three weeks, consisting of 15 sessions (5 days per week) in both treatment groups.
The standard program included hot pack application to the shoulder region for 20 min, conventional transcutaneous electrical nerve stimulation (TENS) for 20 min, and ultrasound therapy at 1.5 W/cm² for 10 min.
In addition to the standard physical therapy program, Group 1 (n=25) received OVM once weekly, while Group 2 (n=24) received sham OVM once weekly.
Pain was evaluated using the Visual Analog Scale (VAS), while functional disability was evaluated using the Shoulder Pain and Disability Index (SPDI).
The ROM values were also recorded.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
56
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Istanbul, Turkey (Türkiye)
- Goztepe Suleyman Yalcin Sehir Hastanesi Fiziksel Tıp ve Rehabilitasyon Klinigi
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Age between 18 and 65 years
- Presence of pain originating from the right shoulder region persisting for at least 6 weeks
- Availability of two-view shoulder radiographs obtained prior to the study to exclude causes of shoulder pain other than AC
- No local corticosteroid injection for shoulder pain within the previous 6 months
- No physical therapy administered for shoulder pain within the previous 6 months
- No use of non-steroidal anti-inflammatory drugs (NSAIDs) during the study period
Availability of laboratory assessments including:
- Complete blood count (CBC)
- Erythrocyte sedimentation rate (ESR)
- Liver function tests (AST, ALT)
- C-reactive protein (CRP)
- Pain intensity score of at least 4 cm on the Visual Analog Scale (VAS, 0-10 cm)
Exclusion Criteria:
- History of shoulder fracture on the affected side
- Prior shoulder surgery
- History of traumatic shoulder instability (subluxation or dislocation)
- History of shoulder or visceral organ surgery within the past 6 months
- History of systemic or inflammatory disease or malignancy
- Presence of metabolic or endocrine bone disease
- Pregnancy
- Neurological disorders affecting upper extremity function
- Psychiatric disorders that could interfere with treatment compliance or symptom evaluation
- Use of antiplatelet medication
- Previous osteopathic treatment
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group 1 (OVM group, n=28) received a standard physical therapy program
|
In the OVM group, mobilization of the liver and diaphragm was performed.
Liver mobilization was applied in three planes (coronal, transverse, and sagittal) for 5 min each, totaling 15 min, while the diaphragm technique was applied for 2 min.
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Sham Comparator: Group 2 (Sham group, n=28) received the same standard physical therapy program
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In the sham OVM group, light pressure and touch were applied with the palm over the same points selected for OVM, without the intention of providing therapeutic effect.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Pain (VAS)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
From enrollment to the end of treatment at 4 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Active shoulder ROM for abduction, flexion, internal rotation, and external rotation
Time Frame: From enrollment to the end of treatment at 4 weeks
|
From enrollment to the end of treatment at 4 weeks
|
|
Shoulder Pain and Disability Index (SPADI)
Time Frame: From enrollment to the end of treatment at 4 weeks
|
From enrollment to the end of treatment at 4 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 10, 2023
Primary Completion (Actual)
May 15, 2024
Study Completion (Actual)
March 20, 2025
Study Registration Dates
First Submitted
July 6, 2026
First Submitted That Met QC Criteria
July 14, 2026
First Posted (Actual)
July 15, 2026
Study Record Updates
Last Update Posted (Actual)
July 15, 2026
Last Update Submitted That Met QC Criteria
July 14, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022/0670
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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