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NCT Number: NCT07497737

OMT 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

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Key information

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UH Ahuja Medical Center, Beachwood, Ohio, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Intra-articular Injection

Drug

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

Osteopathic Manipulative Therapy (OMT)

Other

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

Primary outcomes

  1. 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

Secondary outcomes

  1. 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)

  2. 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)

  3. 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Kevin Killian, DO

CONTACT

[email protected]

216-844-7200

Sophie Chuinard, BA

CONTACT

[email protected]

231-409-4156

Sponsors and collaborators

Lead sponsor

University Hospitals Cleveland Medical Center

Other

Registry information

Official study title

Osteopathic Manipulative Treatment as an Adjunct Therapy for Adhesive Capsulitis

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 27, 2026
Registry last updated
Jun 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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