Shoulder Adhesive CapsulitisNCT07704411
The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis
A study testing physical therapy program in people with Shoulder Adhesive Capsulitis and Osteopathic Manipulative Treatment (OMT), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Adhesive Capsulitis, Osteopathic Manipulative Treatment (OMT)
- What is being tested?
- physical therapy program
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Jan 2023to 20 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Goztepe Suleyman Yalcin Sehir Hastanesi Fiziksel Tıp ve Rehabilitasyon Klinigi
Istanbul
About this study
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.
- Being tested
- physical therapy program, Sham (No Treatment)
- Keywords
- Adhesive capsulitis, osteopathic visceral manipulation, physical therapy, visceral dysfunction
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical therapy programOther
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.
Sham (No Treatment)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (OVM group, n=28) received a standard physical therapy program | Experimental | Not described Receives: Other: physical therapy program |
| Group 2 (Sham group, n=28) received the same standard physical therapy program | Sham comparator | Not described Receives: Other: Sham (No Treatment) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain (VAS)
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (2)
Active shoulder ROM for abduction, flexion, internal rotation, and external rotation
Measured: From enrollment to the end of treatment at 4 weeks
Shoulder Pain and Disability Index (SPADI)
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2026
- Study start10 Jan 2023
- Primary completion15 May 2024
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Adhesive CapsulitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-center, single-blind, randomized-controlled study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medeniyet University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bilinç Doğruöz Karatekin, Istanbul Medeniyet University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07704411
- Sponsor's protocol ID
- 2022/0670
- Status last verified
- Jul 2026
- First submitted
- 6 Jul 2026
- Last updated
- 15 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Osteopathic Visceral Manipulation on Pain, Mobility and Functional Disability in Patients With Right Shoulder Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07704411
- Acronym / sponsor ID
- 2022/0670
- Keywords
- Adhesive capsulitis, osteopathic visceral manipulation, physical therapy, visceral dysfunction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Istanbul Medeniyet UniversityUniversity, hospital or other
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 15 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-center, single-blind, randomized-controlled study
| Arm | Type | Receives |
|---|---|---|
| Group 1 (OVM group, n=28) received a standard physical therapy program | Experimental | Other: physical therapy program |
| Group 2 (Sham group, n=28) received the same standard physical therapy program | Sham comparator | Other: Sham (No Treatment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| physical therapy programIn 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. | Other | Group 1 (OVM group, n=28) received a standard physical therapy program |
| Sham (No Treatment)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. | Other | Group 2 (Sham group, n=28) received the same standard physical therapy program |
Primary outcome
Pain (VAS)
Time frame: From enrollment to the end of treatment at 4 weeks
2 secondary outcomes
Active shoulder ROM for abduction, flexion, internal rotation, and external rotation
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical therapy program in people with Shoulder Adhesive Capsulitis and Osteopathic Manipulative Treatment (OMT), run by Istanbul Medeniyet University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (VAS) (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.