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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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intra-articular Injection | Drug | Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%) |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Sophie Chuinard, BA | Contact | 231-409-4156 | sophie.chuinard@uhhospitals.org | |
| Kevin Killian, DO | Contact | 216-844-7200 | Kevin.Killian@uhhospitals.org |
| Name | Affiliation | Role |
|---|---|---|
| Kevin Killian, DO | University Hospitals | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UH Ahuja Medical Center | Beachwood | Ohio | 44122 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32789092 | Background | 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. | |
| 38844748 | Background | Vita 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. |
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| ID | Term |
|---|---|
| D002062 | Bursitis |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D007270 | Injections, Intra-Articular |
| D026301 | Manipulation, Osteopathic |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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| Osteopathic Manipulative Therapy (OMT) | Other | Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues |
|
| 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 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 at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended. |
| UH St. John Health Center | Westlake | Ohio | 44145 | United States |
|
| UH Westlake Health Center | Westlake | Ohio | 44145 | United States |
|
| 30451406 | Background | Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034. |
| D026201 |
| Musculoskeletal Manipulations |
| D000529 | Complementary Therapies |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |