The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome

Pilot study looking at the Osteopathic Manipulative Treatment (OMT) for various headache types in patients with post-concussion syndrome (PCS). Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Headache Brain Concussion Craniocerebral Trauma Head Injuries, Closed Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Concussion Syndrome Signs and Symptoms Trauma, Nervous System Wounds and Injuries Wounds, Nonpenetrating

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Hackensack Meridian Health - JFK Medical Center

Edison, New Jersey, 08817, United States

About this study

Evidence shows the effectiveness of Osteopathic Manipulative Treatment (OMT) for various headache types, with limited evidence of its use for headaches related to mild traumatic brain injury (MTBI). No studies were found regarding OMT for headaches in patients with post-concussion syndrome (PCS), defined as symptom persistence >3 months after MTBI.

Objective: To evaluate OMT for headaches in patients with PCS. Methods: A controlled pilot study was conducted of patients with PCS who presented to an outpatient interdisciplinary rehabilitation clinic. Twenty-six subjects with symptoms lasting >3 months were enrolled and were randomly assigned to a treatment group (n = 13) and a control group (n = 13). Primary outcome measures were 1) immediate change in headache scores with a visual analog scale (VAS) and 2) change in the 6-item Headache Impact Test (HIT-6) between baseline and follow-up visits. 10 control participants completed HIT-6 between baseline and follow-up visits but did not receive OMT and did not complete VAS. After OMT, immediate VAS changes in treatment group and the improvements in HIT-6 scores for both groups between baseline and follow-up were analyzed for statistical significance.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

diagnosis of mild traumatic brain injury (MTBI),
age 18 years or older
injury occurring >3 months prior, and
headache as a primary symptomatic concern.

Exclusion criteria

history of moderate to severe traumatic brain injury (TBI),
documented intracranial injury,
chronic headache or migraine headache before the injury,
treatment with a headache specialist at the time of injury, or receipt of IV infusion for medication for headache at the time of treatment.

Treatment and study plan

Osteopathic Manipulative Therapy

Other

Osteopathic Manipulative Therapy (OMT) is a non-pharmacological, noninvasive form of manual medicine. Osteopathic practitioners use a wide variety of therapeutic manual techniques to improve physiological function and help restore homeostasis in the body. There is a structural assessment is to identify possible abnormalities of tissue texture. Areas of asymmetry and misalignment of bony landmarks are also evaluated, along with the quality of motion, balance, and organization. These asymmetries, also known as somatic dysfunctions, are then treated by a variety of manual treatments, administered by osteopaths.

Primary outcomes

Immediate Change in Headache Scores With a Visual Analog Scale (VAS)

Time frame: Same day with treatment on visit 1

Change in the headache scores, defined as the different pain pre and post treatment using the visual analog scale (VAS).

VAS is widely used to capture pain, the scale ranges from 0-10 with 0 (best outcome) being no pain and 10 being the worst pain possible (worst outcome).
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.

Time frame: 4 weeks post treatment (Follow-up visit 1)

HIT-6 was completed at baseline and competed to HIT-6 completed post treatment at follow up visit.

Headache Impact Test (HIT-6) is a measure of headache severity and provides information regarding the effect of headache on other domains related to functional participation. The HIT-6 has six questions and the range goes from 36 (best outcome) to a maximum score of 78 (worst outcome). Higher HIT-6 scores indicate increased headache severity and greater functional limitations.

Sponsors and collaborators

Lead sponsor

Hackensack Meridian Health

Other

Registry information

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2020
First posted: Feb 1, 2021
Registry last updated: May 25, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Recruiting