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Nonsteroidal Anti-inflammatory Drug

Topical Diclofenac for Headaches (DITCH Trial)

Phase 3

Recruiting

Led By Duc Tran, MD, PhD

Research Sponsored by Loma Linda University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

18-90 Years old

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and day 14 of treatment.

Awards & highlights

DITCH Trial Summary

This trial will compare the effects of a topical pain relief gel to petroleum jelly on headache intensity and disability.

Who is the study for?

This trial is for adults aged 18-90 who are hospitalized with cervicogenic headaches, can consent for themselves, and speak English or Spanish. Excluded are those on chronic opioid regimens, pregnant women, patients with fibromyalgia or cervical spine procedures history, primary headache from intracranial pathology, known diclofenac sensitivity, recent nerve blocks or steroid injections.Check my eligibility

What is being tested?

The study tests the effectiveness of diclofenac gel versus petroleum jelly in treating cervicogenic headaches. Participants will apply either diclofenac gel or petroleum jelly to their neck four times daily. Their headache severity before and after treatment will be measured using surveys.See study design

What are the potential side effects?

Diclofenac may cause allergic reactions in some people; these could include skin rashes, breathing difficulties if they have asthma or other allergies. It's not suitable post-coronary artery surgery and might interact with certain antiplatelet medications.

DITCH Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 90 years old.

DITCH Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ change between baseline and day 14 of treatment.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~change between baseline and day 14 of treatment.

This trial's timeline: 3 weeks for screening, Varies for treatment, and change between baseline and day 14 of treatment. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Activities of Daily Living Function Assessment

Pain

DITCH Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Diclofenac GelExperimental Treatment1 Intervention

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.

Group II: ControlPlacebo Group1 Intervention

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.

0 / 1Eligibility criteria met

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Who is running the clinical trial?

Loma Linda UniversityLead Sponsor

306 Previous Clinical Trials

260,934 Total Patients Enrolled

Duc Tran, MD, PhDPrincipal InvestigatorLoma Linda University

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What potential risks are associated with the use of Diclofenac Gel?

"Diclofenac Gel is believed to be safely administered, given its Phase 3 status. Thanks to multiple rounds of data collection, it was assigned a score of 3."

Answered by AI

Is this research offering open to participants aged below 25 years?

"To qualify for this medical trial, participants must be between 18 and 90 years of age. For those younger than 18 or aged over 65, there are 19 and 98 respective studies available."

Answered by AI

How many participants are presently enrolled in this clinical trial?

"Indeed, the clinicaltrials.gov website shows that this medical study is currently looking for participants. It was first posted on January 1st 2024 and has since been updated most recently on October 25th 2023 with a requirement of 50 volunteers across one site."

Answered by AI

Is it feasible for me to become a participant in this research endeavor?

"In order to be a suitable candidate for this medical trial, individuals must have cervicogenic headache and meet the age requirements of 18-90. This research project is looking for approximately 50 participants."

Answered by AI

Is this research program still recruiting participants?

"Affirmative. According to the information on clinicaltrials.gov, recruitment for this research project is ongoing. This trial was first released on January 1st 2024 and amended most recently on October 25th 2023; it requires 50 individuals from one medical facility."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Diclofenac Gel in the Treatment of Cervicogenic Headache

Duc Tran, MD, PhD 2024. "Diclofenac Gel in the Treatment of Cervicogenic Headache". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05312645.

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