Diclofenac Gel in the Treatment of Cervicogenic Headache

NCT05312645 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: 5230175
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervicogenic Headache

Keywords

Headache; Cervicogenic; Diclofenac

Outcome Measures

Primary Outcomes (2)

• 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.

Study Arms (2)

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.

Drug: Diclofenac 1% Topical

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.

Other: Petroleum Jelly

Interventions

Diclofenac 1% Topical DRUG

2 grams topically four times daily for 2 weeks to posterior cervical spine

Diclofenac Gel

Petroleum Jelly OTHER

2 grams topically four times daily for 2 weeks to posterior cervical spine

Control

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Years old
• Subject must be able to consent for themselves
• Hospitalized at Loma Linda East Campus Rehabilitation Hospital
• English or Spanish speaking
• 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)).

You may not qualify if:

• 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:
• Known hypersensitivity to diclofenac or any other components of the drug product
• History of asthma, uriticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
• In the setting of coronary artery bypass graft (CABG) surgery.

Sponsors & Collaborators

• Loma Linda University: lead

Study Sites (1)

Tom Vi and Zapara Rehabilitation Pavillion

Loma Linda, California, 92354, United States

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Headache

Interventions

Diclofenac; Petrolatum

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Hydrocarbons

Study Officials

• Duc Tran, MD, PhD

  Loma Linda University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: April 5, 2022
• Study Start: December 1, 2023
• Primary Completion: August 21, 2024
• Study Completion: August 21, 2024
• Last Updated: January 23, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)