Back to resultsDiclofenac Gel in the Treatment of Cervicogenic Headache (DITCH)
Primary Purpose
Cervicogenic Headache
Status
Not yet recruiting
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Diclofenac 1% Topical
Petroleum Jelly
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Headache, Cervicogenic, Diclofenac
Eligibility Criteria
Inclusion Criteria:
- 18-90 Years old
- English Speaking
- Hospitalized at Loma Linda East Campus Rehabilitation Hospital
- Meet ICHD-3-III 11.2.1 criteria for cervicogenic headache (classified as "Definitive" when C4 is satisfied by trial participants, "Probable" when criteria A or B, together with D have been met and "Possible" when only 1 of the criteria listed in C together with criteria D has been met. Avijgan et al., 2019)
Exclusion Criteria:
- Headache secondary to intracranial pathology (i.e. tumors)
- History of cervical spine procedures
- Nerve blocks within past 4 weeks or steroid injections within past 6 months.
- Patients with fibromyalgia
- Chronic pain on continuous opiate regimen (use of opioids on most days >90 days)
- Known allergy to diclofenac gel
- History of coronary artery bypass graft or gastrointestinal bleed
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Diclofenac Gel
Control
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05312645
Brief Title
Diclofenac Gel in the Treatment of Cervicogenic Headache
Acronym
DITCH
Official Title
Diclofenac Gel in the Treatment of Cervicogenic Headache: A Randomized, Double-Blind, Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
January 2025 (Anticipated)
Study Completion Date
January 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Loma Linda University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Headache, Cervicogenic, Diclofenac
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Diclofenac Gel
Arm Type
Experimental
Arm Title
Control
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Diclofenac 1% Topical
Intervention Description
2 grams topically four times daily for 2 weeks to posterior cervical spine
Intervention Type
Other
Intervention Name(s)
Petroleum Jelly
Intervention Description
2 grams topically four times daily for 2 weeks to posterior cervical spine
Primary Outcome Measure Information:
Title
Pain Severity
Description
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.
Time Frame
Change between baseline and day 14 of treatment.
Title
Activities of Daily Living Function Assessment
Description
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.
Time Frame
Change between baseline and day 14 of treatment.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18-90 Years old
English Speaking
Hospitalized at Loma Linda East Campus Rehabilitation Hospital
Meet ICHD-3-III 11.2.1 criteria for cervicogenic headache (classified as "Definitive" when C4 is satisfied by trial participants, "Probable" when criteria A or B, together with D have been met and "Possible" when only 1 of the criteria listed in C together with criteria D has been met. Avijgan et al., 2019)
Exclusion Criteria:
Headache secondary to intracranial pathology (i.e. tumors)
History of cervical spine procedures
Nerve blocks within past 4 weeks or steroid injections within past 6 months.
Patients with fibromyalgia
Chronic pain on continuous opiate regimen (use of opioids on most days >90 days)
Known allergy to diclofenac gel
History of coronary artery bypass graft or gastrointestinal bleed
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Duc Tran, MD, PhD
Phone
9095589273
Email
DATran@llu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cristian Villegas, MD
Email
cvillegas@llu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Duc Tran, MD, PhD
Organizational Affiliation
Loma Linda University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Diclofenac Gel in the Treatment of Cervicogenic Headache
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