Intra-articular Injection
DrugIntra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)
NCT Number: NCT07497737
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
Trial opening soon.
Get Notified18 year–89 year
All sexes
Interventional
Phase 4
UH Ahuja Medical Center, Beachwood, Ohio, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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 frame: 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
Time frame: 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)
Time frame: 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)
Time frame: 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)
Contact information is provided by the study sponsor or research team.
Kevin Killian, DO
CONTACT
Sophie Chuinard, BA
CONTACT
University Hospitals Cleveland Medical Center
Other
Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis
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