Health TrialsbyHealthPanel

OMT for Adhesive Capsulitis

ConditionsAdhesive Capsulitis of the ShoulderFrozen Shoulder
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-89
SponsorUniversity Hospitals Cleveland Medical Center

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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 intervention

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

Treatment groups

300 Participants
are divided into 4 treatment groups
Group A: PT onlyNo intervention 0 interventions
Group B: PT and InjectionActive comparator 1 intervention
Group C: PT and OMTExperimental treatment 1 intervention
Group D: PT, Injection, and OMTExperimental treatment 2 interventions

Trial outcomes

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

Time frame
Up to 12 months

Secondary outcomes

1

Change in Range of Motion of the Shoulder Relative to Baseline

Measured by forward flexion/extension (0deg - 170deg), external rotation (0deg - 60deg), internal rotation (side only - vertebrae), and abduction (0deg - 90deg)

Time frame
Baseline (before treatment) and then 1 month, 3 months, 6 months, and 12 months after treatment has ended
2

Change in Patient Satisfaction as Measured by Treatment Satisfaction Questionnaire for Medication (TSQM)

Scaled on a score from 0 (lowest possible satisfaction) to 100 (highest possible satisfaction)

Time frame
Measured 1 month, 3 months, 6 months, and 12 months after the end of treatment.
3

Change in Pain as Measured by Patient-Reported Pain Score

Measured using the Visual Analogue Scale (VAS), which yields a score from 0 (no pain) to 10 (worst pain imaginable)

Time frame
Measured at baseline (before treatment) then at 3 months, 6 months, and 12 months after treatment has ended.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University Hospitals Cleveland Medical Center

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: