Clinical trial NCT04305223: Dry Needling for Cervicogenic Headache
Official title: Comparison of Dry Needling Versus Upper Extremity Strengthening and Dry Needling for Individuals With Cervicogenic Headache
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Headache
Cervicogenic Headache
Keywords: Headache
Dry Needling
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2020-03-12
Enrollment: 7
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: single-blinded randomized clinical trial
Primary purpose: TREATMENT

Brief summary: This is a single-blinded randomized clinical trial. The primary aim of this study is to compare the effectiveness of dry needling of myofascial trigger points in the muscles of the head and cervical spine in addition to an upper extremity strengthening/stretching exercise program compared to a dry needling group alone on pain scores, cervical range of motion, pain sensitivity and changes in severity and frequency of pain symptoms in individuals with cervicogenic headache.

Detailed description: This is a single-blinded randomized clinical trial. Eligible participants who agree to enroll in the study will be asked to attend four testing sessions. Participants in both groups will receive dry needling to the involved head and cervical muscles and the other group, in addition to receiving a dry needling intervention, will be instructed in a standard home exercise program consisting of strengthening and stretching exercises for the upper quarter. All dry needling (using standard clean technique) will be performed by licensed physical therapists board certified in orthopaedic physical therapy and having a minimum of 5 years of experience treating patient populations with dry needling.

The aim of this research study is to compare he effectiveness of dry needling alone with dry needling and a home exercise program on pain, pain sensitivity, cervical range of motion, and changes in the severity and frequency among individuals with headache symptoms.

Eligibility criteria: Inclusion Criteria:

* Unilateral headache (HA) without side shift
* H/o pain triggered by neck movement
* Limitation in cervical range of motion
* Ispilateral neck, shoulder or arm pain
* Intermittent pain with episodes varying in duration
* Head and neck pain is non-throbbing in nature

Exclusion Criteria:

* Use of anti-coagulation medicine (except low dose aspirin)
* Pregnancy
* Acute or uncontrolled medical illness
* Opioid use within six months
* Fibromyalgia or diffuse painful syndromes in the UE or LE
* Substance abuse
* Presence of fever, vomiting or visual changes

Primary outcomes:
measure: Change in visual analog score for pain level
timeFrame: Baseline, Weeks 1 to 4 post intervention
measure: Change in pain pressure threshold (PPT)
timeFrame: Baseline, Weeks 1 to 4 post intervention
measure: Change in cervical range of motion
timeFrame: Baseline, Weeks 1 to 4 post intervention
measure: Functional outcome measure: Change in neck disability index
timeFrame: Baseline, Weeks 1 to 4 post intervention
measure: Functional outcome measure: Change in headache disability index
timeFrame: Baseline, Weeks 1 to 4 post intervention
measure: Change in Pain Frequency-Severity-Duration (PFDS) Scale
timeFrame: Baseline, Weeks 1 to 4 post intervention
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Kathleen Geist, PT, DPT
role: PRINCIPAL_INVESTIGATOR
References: