OMT for Adhesive Capsulitis

March 31, 2026 updated by: Kevin Killian, University Hospitals Cleveland Medical Center

Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Ohio
      • Beachwood, Ohio, United States, 44122
        • UH Ahuja Medical Center
        • Contact:
        • Principal Investigator:
          • Kevin Killian, DO
        • Sub-Investigator:
          • Madison Sandrella, DO
      • Westlake, Ohio, United States, 44145
        • UH St. John Health Center
        • Principal Investigator:
          • Kevin Killian, DO
        • Sub-Investigator:
          • Madison Sandrella, DO
        • Contact:
      • Westlake, Ohio, United States, 44145

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: PT only
Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy
Active Comparator: PT and Injection
Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) in addition to the standard prescription for physical therapy
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%)
Experimental: PT and OMT
Patients in this group will receive (up to) 4 sessions of OMT spaced at least 2 weeks apart in addition to the standard prescription for physical therapy
Other: Osteopathic Manipulative Therapy (OMT)
Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues
Experimental: PT, Injection, and OMT
Patients in this group will receive an intra-articular injection consisting of a corticosteroid (methylprednisolone acetate) and anesthetics (Lidocaine and Ropivacaine) and (up to) 4 sessions of OMT in addition to the standard prescription for physical therapy
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Recovery as Measured in Months
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
Up to 12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Measured by forward flexion/extension (0deg - 170deg), external rotation (0deg - 60deg), internal rotation (side only - vertebrae), and abduction (0deg - 90deg)
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.
Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction)
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.
Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable)
Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospitals Cleveland Medical Center

Investigators

  • Principal Investigator: Kevin Killian, DO, University Hospitals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2028

Study Registration Dates

First Submitted

March 23, 2026

First Submitted That Met QC Criteria

March 23, 2026

First Posted (Actual)

March 27, 2026

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY20260072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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