OMT for Adhesive Capsulitis

Conditions

• Adhesive Capsulitis of the Shoulder
• Frozen Shoulder

Eligibility Criteria

Sex

ALL

Age

18 Years - 89 Years

Healthy Volunteers

Not accepted

Interventions

• 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

Study Details

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

Key Dates

Start date

Aug 1, 2026

Status verified

Jun 2026

Primary completion

Apr 1, 2027

Completion

May 1, 2028

Study Design

Enrollment

300 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• 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
• 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
• 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

Primary Outcome Measure

Time to Recovery as Measured in Months [ Time Frame: Up to 12 months ]

Central Contacts

• Sophie Chuinard, BA
  231-409-4156
  [email protected]
• Kevin Killian, DO
  216-844-7200
  [email protected]

Locations (3)

Find similar trials in Beachwood, OH

Related Studies

• Adhesive Capsulitis: Prospective Analysis of Efficacy and Financial Impact for Use of Physical Therapy in Treatment
  PHASE4 · Recruiting · Massachusetts General Hospital · Boston, Massachusetts
• Frozen Shoulder and Hormone Replacement Therapy
  PHASE4 · Recruiting · University of California, San Francisco · San Francisco, California