The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Pa… (NCT07704411) | Clinical Trial Compass
CompletedNot Applicable
The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis
Turkey (Türkiye)56 participantsStarted 2023-01-10
Plain-language summary
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.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Pain (VAS)
Timeframe: From enrollment to the end of treatment at 4 weeks