Clinical trial NCT04732338: The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Official title: The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Headache
Post-Concussion Syndrome
Lead sponsor: Hackensack Meridian Health
Sponsor class: OTHER
First posted: 2021-02-01
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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).

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
timeFrame: Same day with treatment on visit 1
measure: Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
timeFrame: 4 weeks post treatment (Follow-up visit 1)
Secondary outcomes:
Other outcomes:
Locations:
city: Edison
country: United States
facility: Hackensack Meridian Health - JFK Medical Center
state: New Jersey
Study officials:
affiliation: HMH-JFK
name: Alphonsa Thomas, DO
role: PRINCIPAL_INVESTIGATOR
References:
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