CompletedEarly Phase 1

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

United States26 participantsStarted 2017-08-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

Timeframe: Same day with treatment on visit 1

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)

Trial details

NCT IDNCT04732338

SponsorHackensack Meridian Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2019-03-31

Results submitted2021-02-16

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