Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Conditions
Keywords
Osteopathic Manipulative Treatment (OMT), Adhesive Capsulitis of the Shoulder, Frozen Shoulder
Brief 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. 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
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
Sponsors
University Hospitals Cleveland Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Recovery as Measured in Months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Range of Motion of the Shoulder Relative to Baseline | Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended | Measured by forward flexion/extension (0deg - 170deg), external rotation (0deg - 60deg), internal rotation (side only - vertebrae), and abduction (0deg - 90deg) |
| Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM) | Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment. | Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction) |
| Change in Pain as Measured by Patient-Reported Pain Score | Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended. | Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable) |
Countries
United States
Contacts
CONTACTSophie Chuinard, BA
CONTACTKevin Killian, DO
PRINCIPAL_INVESTIGATORKevin Killian, DO
University Hospitals
Outcome results
None listed