OMT for Adhesive Capsulitis

Phase 4Not Yet RecruitingNCT07497737

University Hospitals Cleveland Medical Center300 enrolled

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

300

Conditions

Adhesive Capsulitis of the Shoulder

Eligibility

Sex: ALLMin age: 18 YearsMax age: 89 Years

Medical Language ↔ Plain English

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

Locations (3)

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

Outcomes

Primary Outcomes

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

Time frame: Up to 12 months

Secondary Outcomes

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)

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)

Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction)

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

Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable)

Time frame: Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.