Osteopathic Manipulative Therapy for Frozen Shoulder

Not yet recruiting at 2 trial locations
SC
KK
Overseen ByKevin Killian, DO
Age: 18+
Sex: Any
Trial Phase: Phase 4
Sponsor: University Hospitals Cleveland Medical Center
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding Osteopathic Manipulative Treatment (OMT) can accelerate recovery and increase satisfaction for individuals with frozen shoulder, a condition characterized by stiffness and pain in the shoulder. Participants will be divided into four groups to receive various combinations of physical therapy, injections, and OMT. The goal is to identify the most effective combination. Ideal candidates are those diagnosed with frozen shoulder who have not yet begun treatment. Participants will attend follow-up visits and complete surveys to monitor their progress and satisfaction over a year. As a Phase 4 trial, this research focuses on understanding how an already FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, if you are currently receiving treatment for frozen shoulder, you would not be eligible to participate.

What is the safety track record for these treatments?

Research has shown that Osteopathic Manipulative Treatment (OMT) is generally safe and well-tolerated. One study on hands-on therapy for shoulder pain found that these treatments, including OMT, improved shoulder movement and reduced pain without major side effects. Another source noted that OMT effectively manages long-term shoulder injuries, again without significant safety concerns.

For the injection part of the study, corticosteroids and pain relievers like methylprednisolone acetate, Lidocaine, and Ropivacaine are commonly used to ease pain and reduce swelling. These are usually well-tolerated, though some people might experience temporary side effects like soreness or mild swelling at the injection site.

Overall, existing research and current medical practice consider the treatments under study safe.12345

Why are researchers enthusiastic about this study treatment?

Researchers are excited about Osteopathic Manipulative Therapy (OMT) for frozen shoulder because it offers a hands-on approach that may relieve stiffness and pain differently than traditional methods. While typical treatments like physical therapy and corticosteroid injections focus on reducing inflammation and improving range of motion, OMT involves manual techniques to improve joint function and mobility. This approach could provide an alternative for patients seeking a non-invasive option that potentially accelerates recovery and enhances overall shoulder function. Additionally, combining OMT with existing therapies such as physical therapy and injections might optimize treatment outcomes by addressing multiple aspects of the condition simultaneously.

What evidence suggests that this trial's treatments could be effective for frozen shoulder?

Research has shown that Osteopathic Manipulative Treatment (OMT) can help with shoulder issues, such as frozen shoulder. Studies have found that hands-on therapy like OMT significantly reduces shoulder pain and improves movement. One study found that patients experienced immediate relief and increased mobility after OMT sessions. In this trial, some participants will receive OMT alongside physical therapy, while others will receive different treatment combinations. Reports indicate that combining OMT with physical therapy better manages pain and increases patient satisfaction. This suggests that OMT could effectively complement regular treatment for frozen shoulder.12367

Who Is on the Research Team?

KK

Kevin Killian, DO

Principal Investigator

University Hospitals

Are You a Good Fit for This Trial?

This trial is for people newly diagnosed with frozen shoulder (adhesive capsulitis) who have not yet received any treatment. People can't join if they've already been treated, or if they have conditions that make steroid injections unsafe, like uncontrolled diabetes, active infections, bleeding problems, or allergies to steroids.

Inclusion Criteria

I have frozen shoulder and have not had any treatment for it.

Exclusion Criteria

I have adhesive capsulitis and have received or am receiving treatment for it.
I do not have uncontrolled diabetes, active infections, bleeding problems, or steroid allergies.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a standard course of prescribed physical therapy, with some groups also receiving injections and/or up to 4 OMT sessions

Up to 12 months
Regular visits for physical therapy and OMT sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment, with visits at 1 month, 3 months, 6 months, and 1 year

12 months
4 visits (in-person) at 1 month, 3 months, 6 months, and 1 year

What Are the Treatments Tested in This Trial?

Interventions

  • Osteopathic Manipulative Therapy (OMT)

Trial Overview

The study compares standard physical therapy alone or combined with either anti-inflammatory shoulder injections and/or up to four sessions of Osteopathic Manipulative Therapy (OMT), a hands-on technique where doctors move and stretch the shoulder. Participants are randomly assigned to one of four groups.

How Is the Trial Designed?

4

Treatment groups

Experimental Treatment

Active Control

Group I: PT, Injection, and OMTExperimental Treatment2 Interventions
Group II: PT and OMTExperimental Treatment1 Intervention
Group III: PT onlyActive Control1 Intervention
Group IV: PT and InjectionActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

University Hospitals Cleveland Medical Center

Lead Sponsor

Trials
348
Recruited
394,000+

Citations

The Function of Osteopathic Medicine in the Treatment ... - PMC

Following her first session of osteopathic manipulative medicine, the patient reported immediate relief of hand weakness, significant ...

Osteopathic treatment of patients with shoulder pain. A ...

Regarding manual and manipulative therapy to the shoulder and shoulder girdle, a review found that there is fair evidence for the treatment of a variety of ...

Manipulative Therapy for Shoulder Pain and Disorders

The purpose of this study was to conduct a systematic review on manual and manipulative therapy (MMT) for common shoulder pain and disorders.

(PDF) The Function of Osteopathic Medicine in ...

Osteopathic manipulative treatment (OMT) utilizes palpatory ... Use of Osteopathic Manipulation for Treatment of Chronic Shoulder Injury Related ...

The effectiveness of Spencer muscle energy technique ... - PMC

The latest osteopathic manual therapy method widely used is the Spencer Muscle Energy Technique (SMET), adopted in Western clinical ...

Osteopathic manipulation and its applicability in the ...

Osteopathic manipulative treatment (OMT), also known as osteo- pathic manipulative medicine (OMM), is a set of manual techniques, developed by Dr. Andrew Taylor ...

Use of Osteopathic Manipulation for Treatment of Chronic ...

The aim of this report is to describe a case of SIRVA and review treatment options, specifically the role of osteopathic manipulative medicine ( ...