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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

Must not have

Primary headache secondary to intracranial pathology (i.e. tumors)

History of cervical spine procedures

Timeline

Screening 3 weeks

Treatment Varies

Follow Up change between baseline and day 14 of treatment.

Awards & highlights

Approved for 10 Other Conditions

All Individual Drugs Already Approved

Pivotal 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.

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.

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.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 90 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My headaches are caused by a brain tumor.

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I have had surgery on my neck spine.

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I was discharged from acute rehab in less than 14 days.

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I haven't had nerve blocks in the last 4 weeks or steroid injections in the last 6 months.

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I am not allergic to diclofenac, aspirin, or NSAIDs, and have not had a bad reaction to diclofenac gel.

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I have been using opioids for pain management almost daily for more than 90 days.

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I have been diagnosed with fibromyalgia.

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I am taking Aspirin 81mg or Clopidogrel daily.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Activities of Daily Living Function Assessment

Pain

Awards & Highlights

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 9Eligibility criteria met