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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Zaragoza
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Headache Intensity (HIT-6)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Manual Therapy + Exercise Group
Combination of manual therapy and exercises for cervicogenic headache
Intervention: Manual Therapy and Exercises (Other)
Exercise Group
Only exercises for cervicogenic headache
Intervention: Exercise (Other)
Outcomes
Primary Outcomes
Headache Intensity (HIT-6)
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
Test-6 questionnaire (HIT-6) will be used to describe the degree of pain and disability caused by the headache, with a reliability higher than 0.70. The results are classified into four categories that score daily life impact of headache (little or none, some, substantial and severe.
Flexion-rotation test
Time Frame: Change between baseline and post intervention (1 month), after 3 months and after 6 months
This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 32º
Secondary Outcomes
- Craniocervical flexion test(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Global Raiting of Scale (GROC-Scale)(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Upper cervical flexion range of motion(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Headache Intensity(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Adherence to self-treatment scale(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
- Pain Pressure Thresholds(Change between baseline and post intervention (1 month), after 3 months and after 6 months)
Investigators
Jacobo Rodríguez-Sanz
Principal Investigator
Universidad de Zaragoza