Diclofenac Gel in the Treatment of Cervicogenic Headache (DITCH)

Loma Linda University (LLU)

Status and phase: Withdrawn; Phase 3

Conditions: Cervicogenic Headache

Treatments: Other: Petroleum Jelly; Drug: Diclofenac 1% Topical

Study type: Interventional

Funder types: Other

Identifiers

NCT05312645

5230175

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 18-90 Years old
2. Subject must be able to consent for themselves
3. Hospitalized at Loma Linda East Campus Rehabilitation Hospital
4. English or Spanish speaking
5. 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)).

Exclusion criteria

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

   a. 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.

2. Patients on dual antiplatelet therapy

   a. Aspirin 81mg daily or Clopidogrel (or antiplatelet monotherapy) is acceptable

3. History of cervical spine procedures

   a. Spinal cord injury patients with cervical neck injuries that have required operative repair will be excluded from the study.

4. Nerve blocks within past 4 weeks or steroid injections within past 6 months.

5. Patients with fibromyalgia

6. Pregnant women

7. Chronic pain on continuous opiate regimen (use of opioids on most days >90 days)

8. Discharged in less than 14 days from acute inpatient rehabilitation

9. Any contraindication use per diclofenac gel package insert:

   1. Known hypersensitivity to diclofenac or any other components of the drug product
   2. History of asthma, uriticaria, or other allergic-type reactions after taking aspirin or other NSAIDs.
   3. In the setting of coronary artery bypass graft (CABG) surgery.

10. Development of adverse reaction resulting in discontinuation of diclofenac gel

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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0 participants in 2 patient groups, including a placebo group

Diclofenac Gel

Experimental group

Description:

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.

Treatment:

Drug: Diclofenac 1% Topical

Control

Placebo Comparator group

Description:

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.

Treatment:

Other: Petroleum Jelly