Clinical trial NCT05312645: Diclofenac Gel in the Treatment of Cervicogenic Headache
Official title: Diclofenac Gel in the Treatment of Cervicogenic Headache: A Randomized, Double-Blind, Controlled Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Cervicogenic Headache
Keywords: Headache
Cervicogenic
Diclofenac
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2022-04-05
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion criteria:

1. 18-90 Years old
2. Subject must be able to consent for themselves
3. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
4. English or Spanish speaking
5. Complain of a headache, caused by a disorder of the cervical spine and/or it's component (i.e. bony, disc and/or soft tissue elements) usually but not invariably accompanied by neck pain (Avijgan et al, 2019)).

Exclusion criteria:

1. 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.
2. Patients on dual antiplatelet therapy

   a. Aspirin 81mg daily or Clopidogrel (or antiplatelet monotherapy) is acceptable
3. 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.
4. Nerve blocks within past 4 weeks or steroid injections within past 6 months.
5. Patients with fibromyalgia
6. Pregnant women
7. Chronic pain on continuous opiate regimen (use of opioids on most days \>90 days)
8. Discharged in less than 14 days from acute inpatient rehabilitation
9. Any contraindication use per diclofenac gel package insert:

   1. Known hypersensitivity to diclofenac or any other components of the drug product
   2. History of asthma, uriticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
   3. In the setting of coronary artery bypass graft (CABG) surgery.
10. Development of adverse reaction resulting in discontinuation of diclofenac gel

Primary outcomes:
measure: Pain Severity
timeFrame: Change between baseline and day 14 of treatment.
measure: Activities of Daily Living Function Assessment
timeFrame: Change between baseline and day 14 of treatment.
Secondary outcomes:
Other outcomes:
Locations:
city: Loma Linda
country: United States
facility: Tom Vi and Zapara Rehabilitation Pavillion
state: California
Study officials:
affiliation: Loma Linda University
name: Duc Tran, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: