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OMT for Adhesive Capsulitis

NCT07497737 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-06-09

No results posted yet for this study

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

Conditions

  • Adhesive Capsulitis of the Shoulder
  • Frozen Shoulder

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

Sponsors & Collaborators

  • University Hospitals Cleveland Medical Center

    lead OTHER

Principal Investigators

  • Kevin Killian, DO · University Hospitals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-04-01
Completion
2028-05-01
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07497737 on ClinicalTrials.gov