NCT05488158

Brief Summary

Osteopathic Manipulative Therapy/Treatments (OMT) are a non-pharmacologic option for treating patients' pain. As the opioid crisis has developed, the requests for OMT have grown in consequence. This has been associated with a recent focus of opioid addiction and overdose death concerns among physicians and patients. However, the physical toll that OMT takes on the physicians providing the treatments has yet to be robustly investigated. Due to the longitudinal nature of chronic pain, OMT delivery becomes a substantial commitment for the physician offering OMT as an option, especially if the intent is to reduce opioid utilization. Many of the patients treated in our clinic have obesity as a co-morbidity to their chronic pain. The size differential between the patient and provider commonly results in multiple techniques being required to treat the patient's somatic dysfunction, which equates to increased exertion by the provider for each new pain patient. Anecdotal reports from the providers have described a decreased motivation to offer OMT to pain patients due to their own soreness from treating the patients they already have on their panel. Furthermore, the physicians are rarely able to take the time away from their practice during business hours to get their own physical health needs addressed in a timely manner. This study looked at the participants' pain levels from offering OMT to their patients and their motivation to offer OMT as a non-pharmacological intervention for treating pain. The participants will have protected time built into their schedule where a board certified doctor of osteopathy will treat them every two weeks. Over the study's course, the participants' pain levels and motivation to offer OMT to their patients was assessed. Objective outcome measures came from the participant's patient panel reports. Changes in the number of OMT office visits they provide, the number of systems they treated and the morphine equivalents they prescribed was tracked. The project's hypothesis followed that purposefully attending to the participant's physical health will improve their motivation to offer OMT, reduce their pain and reduce their opioid prescribing.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable pain

Timeline
Completed

Started Oct 2020

Typical duration for not_applicable pain

Geographic Reach
1 country

1 active site

Status
completed

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 Start

First participant enrolled

October 22, 2020

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2022

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

February 23, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2022

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 4, 2022

Completed
Last Updated

August 4, 2022

Status Verified

February 1, 2022

Enrollment Period

1.3 years

First QC Date

February 23, 2022

Last Update Submit

August 2, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • Reduction in pain scores

    Osteopathic manipulative therapy was employed to treat physician's physical pain as a wellness initiative

    18 months

Study Arms (2)

MD

ACTIVE COMPARATOR

Allopathic physicians in one arm of the study were treated with OMT to alleviate pain and somatic disfunction. The amount of pain they were experiencing before treatment was recorded using a Likert pain scale.

Other: Osteopathic manipulation

DO

ACTIVE COMPARATOR

Osteopathic physicians in one arm of the study were treated with OMT to alleviate pain and somatic disfunction. The amount of pain they were experiencing before treatment was recorded using a Likert pain scale.

Other: Osteopathic manipulation

Interventions

Pain and somatic disfunction were treated with osteopathic manipulations as deemed appropriate by a trained DO.

DOMD

Eligibility Criteria

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

You may qualify if:

  • Family Medicine physician residents

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fort Wayne Medical Education Program

Fort Wayne, Indiana, 46802, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 23, 2022

First Posted

August 4, 2022

Study Start

October 22, 2020

Primary Completion

February 1, 2022

Study Completion

June 1, 2022

Last Updated

August 4, 2022

Record last verified: 2022-02

Data Sharing

IPD Sharing
Will not share

Dissemination of the aggregate data internally

Locations