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

Hackensack Meridian Health

Status and phase: Completed; Early Phase 1

Conditions: Post-Concussion Syndrome; Headache

Treatments: Other: Osteopathic Manipulative Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04732338

IRB00001814

Details and patient eligibility

About

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).

Full 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.

Enrollment: 26 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

26 participants in 2 patient groups

Study arm - Osteopathic Manipulative Therapy

Experimental group

Description:

Standard of care including physical therapy, occupational therapy and over the counter medication AND OMT as described below: 1. Musculoskeletal examination of the cervical spine. Testing will be comprised of : 1. Range of motion testing involving cervical rotation, lateral side bending, flexion and extension. 2. Muscular palpation of the cervical paraspinals for hypertonicity of the muscles and/or tenderness. 2. Patient placed supine on the examination table. 3. Treatment sessions lasting 5-10 minutes each. OMT techniques: cervical muscle energy, myofascial release of the cervical paraspinals and a suboccipital release. Assessment with Headache Impact Test (HIT-6) at baseline and follow-up visit and change in pain scores between baseline and post treatment.

Treatment:

Other: Osteopathic Manipulative Therapy

Control - Standard of care

No Intervention group

Description:

Standard of care including physical therapy, occupational therapy and over the counter medication.