OMT for Adhesive Capsulitis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Intra-articular Injection, Osteopathic Manipulative Therapy (OMT).
- Who it may be relevant to
- Registry conditions: Adhesive Capsulitis of the Shoulder, Frozen Shoulder. Basic parameters: 18 years — 89 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
Overview
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
Interventions
- Drug Intra-articular Injection
Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%) - Other Osteopathic Manipulative Therapy (OMT)
Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues
Primary outcome measures
- Time to Recovery as Measured in Months [Time frame: Up to 12 months]
Secondary outcome measures (3)
- 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.]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 3 centers
- UH Ahuja Medical Center — Beachwood
- UH St. John Health Center — Westlake
- UH Westlake Health Center — Westlake
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. PMID 32789092
- 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. PMID 38844748
- Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034. PMID 30451406
Identifiers
NCT: NCT07497737 · STUDY20260072