A Phase 4 interventional study of Intra-articular Injection and Osteopathic Manipulative Therapy (OMT) in Adhesive Capsulitis of the Shoulder and Frozen Shoulder, sponsored by University Hospitals Cleveland Medical Center. Not yet recruiting at 3 sites in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by University Hospitals Cleveland Medical Center · Phase 4, Interventional, and Treatment
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:
Visit clinic and/or physical therapy to undergo the treatments associated with their group:
383 studies on the registry are indexed under Bursitis; 111 are open to participants now.
This study's planned enrollment of 300 is above the median of 44 across 346 interventional studies indexed under Bursitis.
Browse Bursitis studies →University Hospitals Cleveland Medical Center is the lead sponsor of 295 studies on the registry; 45 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 30 (83%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy
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
Drug: Intra-articular Injection
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
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
Drug: Intra-articular Injection · Other: Osteopathic Manipulative Therapy (OMT)
Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)
Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues
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
Time frame: Up to 12 months
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)
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)
Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction)
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
Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable)
Time frame: Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.
Plan to share: No
Start is estimated for Dec 2026; primary completion for Apr 2027, 4 months later.
Start moved once since we started tracking on Sep 25, 2026: Aug 2026 → Dec 2026, on Oct 5, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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