Not provided
Not provided
Not provided
Not provided
No Subjects Enrolled
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The intervention will consist of the nursing staff applying 2 grams of diclofenac 1% gel topically to the posterior cervical region four times daily. The control group will receive petroleum jelly topically to the posterior cervical region four times daily. Patients will receive a pre-intervention and post-intervention survey incorporating the Numeric Assessment Scale and Headache Impact Test-6.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diclofenac Gel | Experimental | Nursing staff will apply 2 grams of diclofenac 1% gel topically to the posterior cervical region of the subject four times daily for 14 days. A questionnaire consisting of a Numeric Assessment Scale (NAS) and Headache Impact Test (HIT-6) will be administered at baseline (day 1), day 7, and at the study conclusion (day 14). A complete metabolic panel will obtained on day 0 and on day 14. |
|
| Control | Placebo Comparator | Nursing staff will apply a petroleum gel based compound topically to the posterior cervical region of the subject four times daily for 14 days. A questionnaire consisting of a Numeric Assessment Scale (NAS) and Headache Impact Test (HIT-6) will be administered at baseline (day 1), day 7, and at the study conclusion (day 14). A complete metabolic panel will obtained on day 0 and on day 14. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diclofenac 1% Topical | Drug | 2 grams topically four times daily for 2 weeks to posterior cervical spine |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Severity | Measured with the Numeric Assessment Scale (0 least severe, 10 most severe). This is a composite measurement between pre-intervention baseline and 14 days post-treatment. | Change between baseline and day 14 of treatment. |
| Activities of Daily Living Function Assessment | Measured with Headache Impact Test-6 (score less than 49 indicates little to no impact on daily life, 50-55 indicates some impact, 56-59 indicates substantial impact, greater than 60 indicates severe impact). This is a composite measurement of activities of daily living function between pre-intervention baseline and 14 days post-treatment. Activities of daily living include, but are not limited to, household work, grooming, and social activities. | Change between baseline and day 14 of treatment. |
Not provided
Not provided
Inclusion criteria:
Exclusion criteria:
Primary headache secondary to intracranial pathology (i.e. tumors)
a. While TBI and Stroke patients can suffer headaches as a sequalae of their intracranial pathologies, it is not always the case that their headache is primarily secondary to their pathology but due to other etiologies such as cervicogenic headache or myofascial pain syndrome. History and physical examination by the medical team will help aid in determining the headache's etiology.
Patients on dual antiplatelet therapy
a. Aspirin 81mg daily or Clopidogrel (or antiplatelet monotherapy) is acceptable
History of cervical spine procedures
a. Spinal cord injury patients with cervical neck injuries that have required operative repair will be excluded from the study.
Nerve blocks within past 4 weeks or steroid injections within past 6 months.
Patients with fibromyalgia
Pregnant women
Chronic pain on continuous opiate regimen (use of opioids on most days >90 days)
Discharged in less than 14 days from acute inpatient rehabilitation
Any contraindication use per diclofenac gel package insert:
Development of adverse reaction resulting in discontinuation of diclofenac gel
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Duc Tran, MD, PhD | Loma Linda University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tom Vi and Zapara Rehabilitation Pavillion | Loma Linda | California | 92354 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D051298 | Post-Traumatic Headache |
| D006261 | Headache |
| ID | Term |
|---|---|
| D051271 | Headache Disorders, Secondary |
| D020773 | Headache Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D004008 | Diclofenac |
| D010577 | Petrolatum |
| ID | Term |
|---|---|
| D010648 | Phenylacetates |
| D000146 | Acids, Carbocyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Petroleum Jelly | Other | 2 grams topically four times daily for 2 weeks to posterior cervical spine |
|
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D006838 |
| Hydrocarbons |