NCT07497737

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:
  • standard course of prescribed physical therapy
  • standard course of prescribed physical therapy and an injection of an anti-inflammatory and anesthetics in the shoulder
  • standard course of prescribed physical therapy and (up to) 4 OMT sessions
  • 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 Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for phase_4

Timeline
24mo left

Started Apr 2026

Typical duration for phase_4

Geographic Reach
1 country

3 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress5%
Apr 2026May 2028

First Submitted

Initial submission to the registry

March 23, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 27, 2026

Completed
5 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2027

Expected
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2028

Last Updated

March 27, 2026

Status Verified

March 1, 2026

Enrollment Period

1 year

First QC Date

March 23, 2026

Last Update Submit

March 23, 2026

Conditions

Adhesive Capsulitis of the ShoulderFrozen Shoulder

Keywords

Osteopathic Manipulative Treatment (OMT)Adhesive Capsulitis of the ShoulderFrozen Shoulder

Outcome Measures

Primary Outcomes (1)

  • 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

    Up to 12 months

Secondary Outcomes (3)

  • 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

  • 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.

  • 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.

Study Arms (4)

PT only

NO INTERVENTION

Patients in this group will receive the standard treatment for adhesive capsulitis: prescription for physical therapy

PT and Injection

ACTIVE COMPARATOR

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

PT and OMT

EXPERIMENTAL

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)

PT, Injection, and OMT

EXPERIMENTAL

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 InjectionOther: Osteopathic Manipulative Therapy (OMT)

Interventions

Intra-articular InjectionDRUG

Intra-articular injection consisting of 80 mg of methylprednisolone acetate, 2 mL of lidocaine (1%), and 4 mL of ropivacaine (0.5%)

PT and InjectionPT, Injection, and OMT
Osteopathic Manipulative Therapy (OMT)OTHER

Non-invasive, manual manipulation of the shoulder joint and its surrounding muscles and tissues

PT and OMTPT, Injection, and OMT

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • patients diagnosed with adhesive capsulitis who have not received prior treatment for it

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

UH Ahuja Medical Center

Beachwood, Ohio, 44122, United States

Location

UH St. John Health Center

Westlake, Ohio, 44145, United States

Location

UH Westlake Health Center

Westlake, Ohio, 44145, United States

Location

Related Publications (3)

  • Veera S, Chin J, Kleyn L, Spinelli S, Tafler L. Use of Osteopathic Manipulation for Treatment of Chronic Shoulder Injury Related to Vaccine Administration. Cureus. 2020 Jul 12;12(7):e9156. doi: 10.7759/cureus.9156.

    PMID: 32789092BACKGROUND

  • Vita, F., Pederiva, D., Tedeschi, R. et al. Adhesive capsulitis: the importance of early diagnosis and treatment. J Ultrasound 27, 579-587 (2024). https://doi.org/10.1007/s40477-024-00891-y

    BACKGROUND

  • Allen GM. The diagnosis and management of shoulder pain. J Ultrason. 2018;18(74):234-239. doi: 10.15557/JoU.2018.0034.

    PMID: 30451406BACKGROUND

MeSH Terms

Conditions

Bursitis

Interventions

Injections, Intra-ArticularManipulation, Osteopathic

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

InjectionsDrug Administration RoutesDrug TherapyTherapeuticsMusculoskeletal ManipulationsComplementary TherapiesPhysical Therapy ModalitiesRehabilitation

Study Officials

  • Kevin Killian, DO

    University Hospitals

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sophie Chuinard, BA

CONTACT

231-409-4156sophie.chuinard@uhhospitals.org

Kevin Killian, DO

CONTACT

216-844-7200Kevin.Killian@uhhospitals.org

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DO

Study Record Dates

First Submitted

March 23, 2026

First Posted

March 27, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

April 1, 2027

Study Completion (Estimated)

May 1, 2028

Last Updated

March 27, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(3)