Diclofenac Gel in the Treatment of Cervicogenic Headache

Phase 3

Recruiting

• Conditions: Cervicogenic Headache
• Interventions: Drug: Diclofenac 1% Topical; Other: Petroleum Jelly

• Registration Number: NCT05312645
• Lead Sponsor: Loma Linda University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-28
• Study First Submitted QC: 2022-03-28
• Study First Posted: 2022-04-05
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-02
• Study Start: 2024-12
• Primary Completion: 2025-12
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diclofenac Gel	Diclofenac 1% Topical	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.
Control	Petroleum Jelly	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.

Primary Outcome Measures

Name	Time	Method
Activities of Daily Living Function Assessment	Change between baseline and day 14 of treatment.	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.
Pain Severity	Change between baseline and day 14 of treatment.	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.

Trial Locations

Locations (1)

Tom Vi and Zapara Rehabilitation Pavillion; 🇺🇸 Loma Linda, California, United States