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

NCT04401501 | Completed DMC

• 1 other identifier: N14/2020
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

Cervicogenic headache; exercise; manual therapy; upper cervical spine

Outcome Measures

Primary Outcomes (2)

• Headache Intensity (HIT-6)

  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.

  Change between baseline and post intervention (1 month), after 3 months and after 6 months

• Flexion-rotation test

  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

  Change between baseline and post intervention (1 month), after 3 months and after 6 months

Secondary Outcomes (6)

• 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

• Craniocervical flexion test

  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

• Global Raiting of Scale (GROC-Scale)

  Change between baseline and post intervention (1 month), after 3 months and after 6 months

Study Arms (2)

Manual Therapy + Exercise Group

EXPERIMENTAL

Combination of manual therapy and exercises for cervicogenic headache

Other: Manual Therapy and Exercises

Exercise Group

ACTIVE COMPARATOR

Only exercises for cervicogenic headache

Other: Exercise

Interventions

Manual Therapy and Exercises OTHER

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

Manual Therapy + Exercise Group

Exercise OTHER

Exercises for cervicogenic headache

Exercise Group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Zaragoza: lead

Study Sites (1)

Universidad de Zaragoza

Zaragoza, 50009, Spain

Location

MeSH Terms

Conditions

Post-Traumatic Headache; Headache; Motor Activity

Interventions

Musculoskeletal Manipulations; Exercise

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 20, 2020
• First Posted: May 26, 2020
• Study Start: June 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: April 27, 2021

Record last verified: 2020-05

Locations

ES (1)