Cervicogenic HeadachePhase 3DITCHNCT05312645
Diclofenac Gel in the Treatment of Cervicogenic Headache
A Phase 3 study testing Diclofenac 1% Topical and Petroleum Jelly in people with Cervicogenic Headache, run by Loma Linda University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Cervicogenic Headache
- What is being tested?
- Diclofenac 1% Topical and Petroleum Jelly
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2023to 21 Aug 2024
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 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)).
Who cannot join
- Primary headache secondary to intracranial pathology (i.e. tumors)
- 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
- Aspirin 81mg daily or Clopidogrel (or antiplatelet monotherapy) is acceptable
- History of cervical spine procedures
- Spinal cord injury patients with cervical neck injuries that have required operative repair will be excluded from the study.
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- 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.
- Development of adverse reaction resulting in discontinuation of diclofenac gel
Trial locations and contacts
1 site in 1 country.
United States1 site
Tom Vi and Zapara Rehabilitation Pavillion
Loma Linda, California, 92354
About this study
Official title: 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.
- Conditions
- Cervicogenic Headache
- Being tested
- Diclofenac 1% Topical, Petroleum Jelly
- Keywords
- Headache, Cervicogenic, Diclofenac
- Medical subject headings
- Post-Traumatic Headache, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diclofenac 1% TopicalDrug
2 grams topically four times daily for 2 weeks to posterior cervical spine
Petroleum JellyOther
2 grams topically four times daily for 2 weeks to posterior cervical spine
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Petroleum Jelly |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Change between baseline and day 14 of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2022
- Study startDec 2023 (estimated)
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Why it stopped: No Subjects Enrolled
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervicogenic HeadacheStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Duc Tran, MD, PhD, Principal investigator, Loma Linda University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05312645
- Sponsor's protocol ID
- 5230175
- Acronym
- DITCH
- Status last verified
- Jan 2025
- First submitted
- 28 Mar 2022
- Last updated
- 23 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diclofenac Gel in the Treatment of Cervicogenic Headache: A Randomized, Double-Blind, Controlled Trial
- ClinicalTrials.gov ID
- NCT05312645
- Acronym / sponsor ID
- DITCH / 5230175
- Conditions
- Cervicogenic Headache
- Keywords
- Headache, Cervicogenic, Diclofenac
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No Subjects Enrolled
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Study start
- Dec 2023 (estimated)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 5 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Diclofenac Gel | Experimental | Drug: Diclofenac 1% TopicalNursing 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 | Placebo comparator | Other: Petroleum JellyNursing 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-90 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)).
Key exclusion criteria (16 listed)
- Primary headache secondary to intracranial pathology (i.e. tumors)
- Patients on dual antiplatelet therapy
- History of cervical spine procedures
- Nerve blocks within past 4 weeks or steroid injections within past 6 months.
- Patients with fibromyalgia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diclofenac 1% Topical2 grams topically four times daily for 2 weeks to posterior cervical spine | Drug | Diclofenac Gel |
| Petroleum Jelly2 grams topically four times daily for 2 weeks to posterior cervical spine | Other | Control |
Primary outcome
Pain Severity
Time frame: 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.
Activities of Daily Living Function Assessment
Time frame: 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.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Duc Tran, MD, PhD principal investigator
Loma Linda University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Diclofenac 1% Topical and Petroleum Jelly in people with Cervicogenic Headache, run by Loma Linda University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 23 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Severity (time frame: Change between baseline and day 14 of treatment.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2025.