Effects of Manual Therapy on the Upper Cervical Spine Combined With Exercise vs Isolated Exercise in Patients With Cervicogenic Headache.

NCT ID: NCT04401501

Last Updated: 2021-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-06-01
• Study Completion Date: 2021-01-01

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.

Conditions

Cervicogenic Headache; Headache

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Manual Therapy + Exercise Group

Combination of manual therapy and exercises for cervicogenic headache

Group Type: EXPERIMENTAL

Manual Therapy and Exercises

Intervention Type: OTHER

Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache

Exercise Group

Only exercises for cervicogenic headache

Group Type: ACTIVE_COMPARATOR

Exercise

Intervention Type: OTHER

Exercises for cervicogenic headache

Interventions

Manual Therapy and Exercises

Combination of physiotherapy (manual therapy) techniques and exercises for cervicogenic headache

Intervention Type: OTHER

Exercise

Exercises for cervicogenic headache

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad de Zaragoza

OTHER

Sponsor Role: lead

Responsible Party

Jacobo Rodríguez-Sanz

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Universidad de Zaragoza

Zaragoza, , Spain

Countries

Spain

Other Identifiers

N14/2020

Identifier Type: -

Identifier Source: org_study_id