Diclofenac Gel in the Treatment of Cervicogenic Headache

Last updated: January 21, 2025
Sponsor: Loma Linda University
Overall Status: Trial Not Available

Phase

3

Condition

Chronic Pain

Pain (Pediatric)

Neck Pain

Treatment

Diclofenac 1% Topical

Petroleum Jelly

Clinical Study ID

NCT05312645
5230175
  • Ages 18-90
  • All Genders

Study 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

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'scomponent (i.e. bony, disc and/or soft tissue elements) usually but not invariablyaccompanied by neck pain (Avijgan et al, 2019)).

Exclusion

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 theirintracranial pathologies, it is not always the case that their headache is primarilysecondary to their pathology but due to other etiologies such as cervicogenicheadache or myofascial pain syndrome. History and physical examination by themedical 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 requiredoperative 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:

  10. Known hypersensitivity to diclofenac or any other components of the drugproduct

  11. History of asthma, uriticaria, or other allergic-type reactions after takingaspirin or other NSAIDs.

  12. In the setting of coronary artery bypass graft (CABG) surgery.

  13. Development of adverse reaction resulting in discontinuation of diclofenac gel

Study Design

Treatment Group(s): 2
Primary Treatment: Diclofenac 1% Topical
Phase: 3
Study Start date:
December 01, 2023
Estimated Completion Date:
August 21, 2024

Connect with a study center

  • Tom Vi and Zapara Rehabilitation Pavillion

    Loma Linda, California 92354
    United States

    Site Not Available

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