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Osteopathic Manipulative Therapy · 1 trial · 2 indications
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).
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.
| Arm | Type | Description |
|---|---|---|
| Study arm - Osteopathic Manipulative Therapy | EXPERIMENTAL | 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. |
| Control - Standard of care | NO_INTERVENTION | Standard of care including physical therapy, occupational therapy and over the counter medication. |
| Name | Type | Description |
|---|---|---|
| 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. |
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, ...
Osteopathic Manipulative Therapy is used for the management of headaches, specifically headaches associated with post-concussion syndrome. It is being studied as a treatment approach for this condition in a clinical trial setting.
Osteopathic Manipulative Therapy is being developed by Meridian Bioscience Inc, a company traded on the stock exchange under the ticker symbol VIVO.
Osteopathic Manipulative Therapy is in Phase 1 clinical development. It is an investigational therapy and has not yet been approved by regulatory authorities. The therapy is still undergoing clinical evaluation for its safety and effectiveness.
Osteopathic Manipulative Therapy has one completed clinical trial registered under the identifier NCT0473238. This trial, titled "The Effectiveness of Osteopathic Manipulative Medicine in the Management of Headaches Associated With Post Concussion Syndrome," was an early Phase 1 study conducted in the United States with 26 participants.
Osteopathic Manipulative Therapy is also known as Osteopathic Manipulative Medicine. The clinical trial NCT0473238 uses the term "Osteopathic Manipulative Medicine" to refer to the same therapeutic approach being studied for headaches associated with post-concussion syndrome.