Clinical trial NCT04401501: Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.
Official title: Short- and Mid-Term Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache. A Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervicogenic Headache
Headache
Keywords: Cervicogenic headache
exercise
manual therapy
upper cervical spine
Lead sponsor: Universidad de Zaragoza
Sponsor class: OTHER
First posted: 2020-05-26
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Cervicogenic headache is defined as unilateral headache associated with neck pain. Effect of manual translatoric therapy of the upper cervical spine associated with cervical exercises in these patients is currently unknown. Our aim was to determine if adding manual therapy to an exercise and home-exercise program improved effects on symptoms and function in short- and mid-term in patients with cervicogenic headache.

A randomized controlled study will be conducted with 40 subjects with cervicogenic headache. Each group will receive four 20-minute sessions weekly and a home-exercise program. Upper cervical flexion, flexion-rotation test, Impact Headache Test-6 (HIT-6), headache intensity, craniocervical flexion test, pain pressure thresholds and Global Rating of Change (GROC)-Scale will be assessed at end of the intervention, at 3- and at 6-month follow-ups.


Eligibility criteria: Inclusion Criteria:

* Diagnosis of cervicogenic headache according to Sjaastad et al. Subjects will have to fulfill both parts I and III of the major criteria for diagnosis (pain aggravated by neck movement, sustained position or external pressure, restricted cervical range of motion, and unilateral pain starting in the neck and radiating to the frontotemporal region)
* Hypomobility in one or more segments of C0-1, C1-2, C2-3 through manual evaluation.
* A positive result in the flexion-rotation test.
* A failure to pass stage 2 (24 mmHg) of the craniocervical flexion test.
* Be at least 18 years old.
* Have signed the informed consent.

Exclusion Criteria:

* Contraindications for manual therapy or exercise.
* Participation in exercise or manual therapy programs in the last three months.
* Inability to maintain supine position.
* The use of pacemakers (the magnets in the CROM device could alter their signal).
* Inability to perform the flexion-rotation test.
* Language difficulties.
* Pending litigation or lawsuits.

Primary outcomes:
measure: Headache Intensity (HIT-6)
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Flexion-rotation test
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Secondary outcomes:
measure: Upper cervical flexion range of motion
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Headache Intensity
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Craniocervical flexion test
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Pain Pressure Thresholds
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Global Raiting of Scale (GROC-Scale)
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
measure: Adherence to self-treatment scale
timeFrame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Universidad de Zaragoza
Study officials:
References: