Diclofenac Gel in the Treatment of Cervicogenic Headache

Cervicogenic Headache Clinical Trial

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Official title:

Diclofenac Gel in the Treatment of Cervicogenic Headache: A Randomized, Double-Blind, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05312645
• Other study ID #: 5230175
• Status: Recruiting
• Phase: Phase 3
• Start date: June 2024
• Est. completion date: June 2025

Study information

• Verified date: February 2024
• Source: Loma Linda University
• Contact: Duc Tran, MD, PhD
• Phone: 9095589273
• Email: DATran[@]llu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Drug:
• Diclofenac 1% Topical
2 grams topically four times daily for 2 weeks to posterior cervical spine

Other:
• Petroleum Jelly
2 grams topically four times daily for 2 weeks to posterior cervical spine

Locations

Country	Name	City	State
United States	Tom Vi and Zapara Rehabilitation Pavillion	Loma Linda	California

Sponsors (1)

Lead Sponsor	Collaborator
Loma Linda University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.