Headache, Post-Concussion Syndrome
Conditions
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.
Interventions
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.
Sponsors
Hackensack Meridian Health
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | 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. | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Study Arm - Osteopathic Manipulative Therapy 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.
Osteopathic Manipulative Therapy: 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. | 10 |
| Control - Standard of Care Standard of care including physical therapy, occupational therapy and over the counter medication. | 10 |
| Total | 20 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 3 | 3 |
Baseline characteristics
| Characteristic | Control - Standard of Care | Total | Study Arm - Osteopathic Manipulative Therapy |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 10 Participants | 19 Participants | 9 Participants |
| Age, Continuous | 42 years STANDARD_DEVIATION 17 | 43.5 years STANDARD_DEVIATION 16 | 45 years STANDARD_DEVIATION 15 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 10 participants | 10 participants | 10 participants |
| Sex: Female, Male Female | 6 Participants | 13 Participants | 7 Participants |
| Sex: Female, Male Male | 4 Participants | 7 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 10 | 0 / 10 |
| other Total, other adverse events | 0 / 10 | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 |
Outcome results
Primary
Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit.
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.
Time frame: 4 weeks post treatment (Follow-up visit 1)
Population: Pre and post intervention HIT-6 scores and change between the two.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Study Arm - Osteopathic Manipulative Therapy | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Initial HIT-6 score | 63.0 units on a scale |
| Study Arm - Osteopathic Manipulative Therapy | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Post-intervention HIT-6 score | 60.0 units on a scale |
| Study Arm - Osteopathic Manipulative Therapy | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Change in HIT-6 score | 3.5 units on a scale |
| Control - Standard of Care | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Initial HIT-6 score | 62.0 units on a scale |
| Control - Standard of Care | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Post-intervention HIT-6 score | 60.5 units on a scale |
| Control - Standard of Care | Change in the 6-item Headache Impact Test (HIT-6) Between Baseline and Follow-up Visit. | Change in HIT-6 score | 2.0 units on a scale |
Primary
Immediate Change in Headache Scores With a Visual Analog Scale (VAS)
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).
Time frame: Same day with treatment on visit 1
Population: We captured the pre and post VAS score and the change between the two.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Study Arm - Osteopathic Manipulative Therapy | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Initial VAS score | 5.6 units on a scale | Standard Deviation 1.7 |
| Study Arm - Osteopathic Manipulative Therapy | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Post intervention VAS score | 3.5 units on a scale | Standard Deviation 2.1 |
| Study Arm - Osteopathic Manipulative Therapy | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Change in VAS score | 2 units on a scale | Standard Deviation 1.8 |
| Control - Standard of Care | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Initial VAS score | NA units on a scale | — |
| Control - Standard of Care | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Post intervention VAS score | NA units on a scale | — |
| Control - Standard of Care | Immediate Change in Headache Scores With a Visual Analog Scale (VAS) | Change in VAS score | NA units on a scale | — |