Adhesive Capsulitis of the ShoulderPhase 4NCT07497737
OMT for Adhesive Capsulitis
A Phase 4 study testing Intra-articular Injection and Osteopathic Manipulative Therapy (OMT) in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
Trial summary
The goal of this clinical trial is to learn if Osteopathic Manipulative Treatment (OMT) is an effective addition to treatment of adhesive capsulitis. OMT is a non-invasive treatment in which a doctor gently moves and stretches muscles, joints, and tissues manually. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- What is being tested?
- Intra-articular Injection and Osteopathic Manipulative Therapy (OMT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Dec 2026to 1 May 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients diagnosed with adhesive capsulitis who have not received prior treatment for it
Who cannot join
- patients with contraindications to corticosteroid injections (uncontrolled diabetes, active infection, bleeding disorders, or corticosteroid hypersensitivity)
- patients diagnosed with adhesive capsulitis who have received (or are currently receiving) treatment for it
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States3 sites
UH Ahuja Medical Center
Beachwood, Ohio, 44122
Sophie Chuinard, BA, 231-409-4156, sophie.chuinard@uhhospitals.org
Kevin Killian, DO
UH St. John Health Center
Westlake, Ohio, 44145
Kevin Killian, DO, 216-844-2015, kevin.killian@uhhospitals.org
Kevin Killian, DO
UH Westlake Health Center
Westlake, Ohio, 44145
Kevin Killian, DO, 216-844-2015, kevin.killian@uhhospitals.org
About this study
Official title: Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
The goal of this clinical trial is to learn if Osteopathic Manipulative Treatment (OMT) is an effective addition to treatment of adhesive capsulitis. OMT is a non-invasive treatment in which a doctor gently moves and stretches muscles, joints, and tissues manually. Adhesive capsulitis is more commonly known as "frozen shoulder" and describes a shoulder that becomes stiff, painful, and limited in its motion due to some structural change in the joint. The main questions it aims to answer are:
Is recovery faster when OMT is added to regular treatment? Are patients that underwent OMT more satisfied with their treatment?
Read more
Researchers will compare patients who underwent OMT to patients who did not to see if OMT is an effective additional treatment for frozen shoulder.
Participants will:
- Be assigned to one of the four experimental groups
- Visit clinic and/or physical therapy to undergo the treatments associated with their group:
- standard course of prescribed physical therapy
- standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder
- standard course of prescribed physical therapy and (up to) 4 OMT sessions
- standard course of prescribed physical therapy, an injection of an anti-inflammatory and anesthetics in the shoulder, and (up to) 4 OMT sessions.
- Visit clinic 1 month, 3 months, 6 months, and 1 year after treatment is complete
- Complete a survey about how satisfied they are with their treatment 1 month, 3 months, 6 months, and 1 year after it is complete
- Being tested
- Intra-articular Injection, Osteopathic Manipulative Therapy (OMT)
- Keywords
- Osteopathic Manipulative Treatment (OMT), Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra-articular InjectionDrug
Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)
Osteopathic Manipulative Therapy (OMT)Other
Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues
| Study group | Role | What they receive |
|---|---|---|
| PT only | No intervention | Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy |
| PT and Injection | Active comparator | Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) in addition to the standard prescription for physical therapy Receives: Drug: Intra-articular Injection |
| PT and OMT | Experimental | Patients in this group will receive (up to) 4 sessions of OMT spaced at least 2 weeks apart in addition to the standard prescription for physical therapy Receives: Other: Osteopathic Manipulative Therapy (OMT) |
| PT, Injection, and OMT | Experimental | Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) and (up to) 4 sessions of OMT in addition to the standard prescription for physical therapy Receives: Drug: Intra-articular Injection; Other: Osteopathic Manipulative Therapy (OMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Recovery as Measured in Months
The number of months separating the initial visit and the final treatment visit. The time taken for the provider to deem further treatment unnecessary
Measured: Up to 12 months
Secondary outcomes (3)
Change in Range of Motion of the Shoulder Relative to Baseline
Measured by forward flexion/extension (0deg - 170deg), external rotation (0deg - 60deg), internal rotation (side only - vertebrae), and abduction (0deg - 90deg)
Measured: Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended
Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM)
Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction)
Measured: Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment.
Change in Pain as Measured by Patient-Reported Pain Score
Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable)
Measured: Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2026
- Study start1 Dec 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Adhesive Capsulitis of the ShoulderStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Killian, University Hospitals Cleveland Medical Center
- Investigators
- Kevin Killian, DO, Principal investigator, University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07497737
- Sponsor's protocol ID
- STUDY20260072
- Status last verified
- Oct 2026
- First submitted
- 23 Mar 2026
- Last updated
- 5 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Veera S, Chin J, Kleyn L, Spinelli S, Tafler L. Use of Osteopathic Manipulation for Treatment of Chronic Shoulder Injury Related to Vaccine Administration. Cureus. 2020 Jul 12;12(7):e9156. doi: 10.7759/cureus.9156.
PubMed 32789092Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6.
PubMed 38844748Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034.
PubMed 30451406
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT07497737
- Acronym / sponsor ID
- STUDY20260072
- Keywords
- Osteopathic Manipulative Treatment (OMT), Adhesive Capsulitis of the Shoulder, Frozen Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 May 2028 (estimated)
- First posted
- 27 Mar 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 goal of this clinical trial is to learn if Osteopathic Manipulative Treatment (OMT) is an effective addition to treatment of adhesive capsulitis. OMT is a non-invasive treatment in which a doctor gently moves and stretches muscles, joints, and tissues manually. Adhesive capsulitis is more commonly known as "frozen shoulder" and describes a shoulder that becomes stiff, painful, and limited in its motion due to some structural change in the joint. The main questions it aims to answer are:
Is recovery faster when OMT is added to regular treatment? Are patients that underwent OMT more satisfied with their treatment?
Researchers will compare patients who underwent OMT to patients who did not to see if OMT is an effective additional treatment for frozen shoulder.
Participants will:
- Be assigned to one of the four experimental groups
- Visit clinic and/or physical therapy to undergo the treatments associated with their group:
- standard course of prescribed physical therapy
- standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder
- standard course of prescribed physical therapy and (up to) 4 OMT sessions
- standard course of prescribed physical therapy, an injection of an anti-inflammatory and anesthetics in the shoulder, and (up to) 4 OMT sessions.
- Visit clinic 1 month, 3 months, 6 months, and 1 year after treatment is complete
- Complete a survey about how satisfied they are with their treatment 1 month, 3 months, 6 months, and 1 year after it is complete
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| PT only | No intervention | –Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy |
| PT and Injection | Active comparator | Drug: Intra-articular InjectionPatients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) in addition to the standard prescription for physical therapy |
| PT and OMT | Experimental | Other: Osteopathic Manipulative Therapy (OMT)Patients in this group will receive (up to) 4 sessions of OMT spaced at least 2 weeks apart in addition to the standard prescription for physical therapy |
| PT, Injection, and OMT | Experimental | Drug: Intra-articular Injection, Other: Osteopathic Manipulative Therapy (OMT)Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) and (up to) 4 sessions of OMT in addition to the standard prescription for physical therapy |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients diagnosed with adhesive capsulitis who have not received prior treatment for it
Key exclusion criteria (2 listed)
- patients with contraindications to corticosteroid injections (uncontrolled diabetes, active infection, bleeding disorders, or corticosteroid hypersensitivity)
- patients diagnosed with adhesive capsulitis who have received (or are currently receiving) treatment for it
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 |
|---|---|---|
| Intra-articular InjectionIntra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%) | Drug | PT and Injection, PT, Injection, and OMT |
| Osteopathic Manipulative Therapy (OMT)Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues | Other | PT and OMT, PT, Injection, and OMT |
Primary outcome
Time to Recovery as Measured in Months
Time frame: Up to 12 months
The number of months separating the initial visit and the final treatment visit. The time taken for the provider to deem further treatment unnecessary
3 secondary outcomes
Change in Range of Motion of the Shoulder Relative to Baseline
Time frame: Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended
Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment.
Change in Pain as Measured by Patient-Reported Pain Score
Time frame: Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2026.
- Background: PubMed 32789092Veera S, Chin J, Kleyn L, Spinelli S, Tafler L. Use of Osteopathic Manipulation for Treatment of Chronic Shoulder Injury Related to Vaccine Administration. Cureus. 2020 Jul 12;12(7):e9156. doi: 10.7759/cureus.9156.
- Background: PubMed 38844748Vita F, Pederiva D, Tedeschi R, Spinnato P, Origlio F, Faldini C, Miceli M, Stella SM, Galletti S, Cavallo M, Pilla F, Donati D. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound. 2024 Sep;27(3):579-587. doi: 10.1007/s40477-024-00891-y. Epub 2024 Jun 6.
- Background: PubMed 30451406Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034.
- Individual participant dataSharing planned: No
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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.
Kevin Killian, DO principal investigator
University Hospitals
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Intra-articular Injection and Osteopathic Manipulative Therapy (OMT) in people with Adhesive Capsulitis of the Shoulder and Frozen Shoulder, run by University Hospitals Cleveland Medical Center at 3 sites in United States.
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 1 inclusion and 2 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: opening soon, as of the sponsor's last update on 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sophie Chuinard, BA (231-409-4156, sophie.chuinard@uhhospitals.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Recovery as Measured in Months (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07497737, which also lists 3 linked publications.
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 5 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.