Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
| Registry | NCT07497737 |
|---|---|
| Status | Not yet recruiting |
| Phase | Phase 4 |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 300 (Estimated) |
| Sponsor | University Hospitals Cleveland Medical Center (Other) |
| Conditions | Adhesive Capsulitis of the Shoulder, Frozen Shoulder |
| Interventions | Intra-articular Injection, Osteopathic Manipulative Therapy (OMT) (Drug, other) |
| Dates | start 2026-12-01 (estimated), primary completion 2027-04-01 (estimated), completion 2028-05-01 (estimated), first posted 2026-03-27, last updated 2026-10-05 |
| Locations | 3 sites in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Adhesive Capsulitis of the Shoulder All trials for Frozen Shoulder All trials of Intra-articular Injection All trials of Osteopathic Manipulative Therapy (OMT)
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:
1. standard course of prescribed physical therapy
2. standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder
3. standard course of prescribed physical therapy and (up to) 4 OMT sessions
4. 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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| 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 Injection | 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 |
| 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 |
Sex: All, ages: 18 Years to 89 Years
Inclusion Criteria: * patients diagnosed with adhesive capsulitis who have not received prior treatment for it Exclusion Criteria: * 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
| Facility | City | Country | Status |
|---|---|---|---|
| UH Ahuja Medical Center | Beachwood, Ohio | United States | |
| UH St. John Health Center | Westlake, Ohio | United States | |
| UH Westlake Health Center | Westlake, Ohio | United States |