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NCT Number: NCT04401501

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

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.

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Key information

Conditions

Cervicogenic Headache Behavior Brain Diseases Central Nervous System Diseases Headache Headache Disorders Headache Disorders, Secondary Motor Activity Nervous System Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Post-Traumatic Headache Signs and Symptoms

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Zaragoza

Zaragoza, 50009, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Manual Therapy and Exercises

Other

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

Exercise

Other

Exercises for cervicogenic headache

Primary outcomes

  1. 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.

  2. 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

  1. Upper cervical flexion range of motion

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

    Active flexion of the upper cervical spine will be measured in standing position using a CROM device

  2. Headache Intensity

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

    Headache intensity will be assessed on a visual analogue scale from 0 to 10 cm.

  3. Craniocervical flexion test

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

    This test will be used to measure the strength of the deep flexor muscles. The activation and resistance of the deep flexor muscles will be evaluated in five progressive pressure increases of 2 mmHg up to a maximum of 30 mmHg. The patient will pass to the next level after reaching one certain level three times.

  4. Pain Pressure Thresholds

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

    Pain pressure thresholds will be measured using a digital algometer (Somedic AB Farsta, Somedic SenseLab AB, Sweden) with a round surface area of 1 cm2. Pressure will be applied at a rate of 1 kg/cm2/s, perpendicular to the skin. Pressure pain thresholds will be assessed over six points bilaterally with the subject in supine position: suboccipital region, C2-3, C5-6, elevator of scapula, trapezius and first metacarpal joint.

  5. Global Raiting of Scale (GROC-Scale)

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

    GROC-Scale will be used to measure the personal evolution that the patient had experienced. This scale is considered to be an efficient way to score patients' perceived clinical change and test-reliability has shown to be excellent (ICC=0.90).

  6. Adherence to self-treatment scale

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

    This scale will be used in order to measure the adherence to self-treatment at home. Patients will be asked to choose between the following answers: "I have done the exercises every day"; "I have performed the exercises 4-6 days a week"; "I have performed the exercises 1-3 days a week"; "I have performed the exercises less than 1 day a week"; or "I have not performed them".

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Official study 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.

Important dates

Study start
2020
Primary completion
2020
Study completion
2021
First posted
May 26, 2020
Registry last updated
Apr 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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