The Role of Osteopathic Manipulative Medicine in Recovery From Concussions

NCT04932278 | Terminated DMC

• 1 other identifier: STUDY4542
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to study whether adding osteopathic manipulative treatment (OMT) to usual care of concussed patients will enhance their recovery.

Conditions

Concussion, Brain

Keywords

concussion; Sport-related; Osteopathic manipulative treatment

Outcome Measures

Primary Outcomes (1)

• SCAT5 symptom evaluation score

  Symptom evaluation score is a self-reported measure of the participants' post-concussion symptoms. Participants are scored on Total Number of Symptoms (ranges 0 to 22) and Symptom Severity Score (ranges 0 to 132). Higher scores represent worse outcome.

  through study completion, up to 4 weeks

Secondary Outcomes (3)

• Head position tracking accuracy

  2 weeks from injury

• Head force tracking accuracy

  2 weeks from injury

• Return to play duration

  through study completion, up to 4 weeks

Study Arms (2)

Usual Care Group

ACTIVE COMPARATOR

Participants in this group will receive routine care for the management and treatment of concussions

Procedure: Usual care

OMT Group

EXPERIMENTAL

Participants who are randomized into the OMT group will receive OMT in addition to their usual care.

Procedure: Osteopathic manipulative treatment; Procedure: Usual care

Interventions

Osteopathic manipulative treatment PROCEDURE

Osteopathic manipulative treatment (OMT) is hands-on care provided by an osteopathic physician (D.O.). During osteopathic manipulative treatment, an osteopathic physician may move participants' muscles and joints using osteopathic techniques including stretching, gentle pressure and resistance, as well as thrust techniques that apply a quick, therapeutic force of brief duration that travels a short distance.

OMT Group

Usual care PROCEDURE

Routine concussion management with healthcare professionals.

OMT Group; Usual Care Group

Eligibility Criteria

• Age: 13 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age between 13-55 years
• Concussion sustained within the last 12 days

You may not qualify if:

• Contraindications to OMT, such as skull fracture, cervical fracture, signs of intracranial bleeding, or stroke
• Neck surgery within the last 6 months
• Any conditions recognized by a physician as contraindicating or impeding protocol implementation
• Will not be under the care of a healthcare professional
• Any active (or pending) worker's compensation, disability, or personal injury claims related to their concussion injury

Sponsors & Collaborators

• Michigan State University: lead
• American Osteopathic Association: collaborator

Study Sites (1)

MSU Center for Orthopedic Research

East Lansing, Michigan, 48824, United States

Location

MeSH Terms

Conditions

Brain Concussion

Interventions

Manipulation, Osteopathic

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: For this study, participants will be randomly assigned to 1. Usual care, or 2. Usual care and OMT.

Study Record Dates

• First Submitted: June 11, 2021
• First Posted: June 21, 2021
• Study Start: September 22, 2021
• Primary Completion: July 9, 2025
• Study Completion: July 10, 2025
• Last Updated: April 16, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)