Diclofenac Gel in the Treatment of Cervicogenic Headache (DITCH)

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Drug: Diclofenac 1% Topical; Other: Petroleum Jelly

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • Loma Linda, California, United States, 92354
      • Tom Vi and Zapara Rehabilitation Pavillion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diclofenac Gel; 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.	Drug: Diclofenac 1% Topical; 2 grams topically four times daily for 2 weeks to posterior cervical spine
Placebo Comparator: Control; 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.	Other: Petroleum Jelly; 2 grams topically four times daily for 2 weeks to posterior cervical spine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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.

Collaborators and Investigators

• Sponsor: Loma Linda University
• Investigators: Principal Investigator: Duc Tran, MD, PhD, Loma Linda University

Study record dates

Study Major Dates

• Study Start (Estimated): December 1, 2023
• Primary Completion (Actual): August 21, 2024
• Study Completion (Actual): August 21, 2024

Study Registration Dates

• First Submitted: March 28, 2022
• First Submitted That Met QC Criteria: March 28, 2022
• First Posted (Actual): April 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: January 21, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: Headache; Diclofenac; Cervicogenic
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Dermatologic Agents; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; Cyclooxygenase Inhibitors; Emollients; Diclofenac; Petrolatum
• Other Study ID Numbers: 5230175

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes