Manual Therapy and Exercise in Patients With Cervicogenic Headache

NCT01580280 | Completed DMC

• 1 other identifier: 12/01-006
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

Hypothesis: The group of cervicogenic headache patients receiving upper cervical and upper thoracic thrust manipulation will demonstrate significant and clinically important changes in outcomes when compared to the mobilization and exercise group.

Conditions

Cervicogenic Headache

Keywords

Cervicogenic; Headache; Neck Pain; Manipulation; Mobilization; Exercise

Outcome Measures

Primary Outcomes (16)

• Headache Frequency

  The number of headache days in the past week (as registered in headache diary)

  Baseline

• Headache Frequency

  The number of headache days in the past week (as registered in headache diary)

  1-week

• Headache Frequency

  The number of headache days in the past week (as registered in headache diary)

  4-weeks

• Headache Frequency

  The number of headache days in the past week (as registered in headache diary)

  3-months

• Headache Intensity

  Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  Baseline

• Headache Intensity

  Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  1-week

• Headache Intensity

  Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  4-weeks

• Headache Intensity

  Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

  3-months

• Headache Duration

  Average number of headache hours in the last week (as registered in the headache diary)

  Baseline

• Headache Duration

  Average number of headache hours in the last week (as registered in the headache diary)

  1-week

• Headache Duration

  Average number of headache hours in the last week (as registered in the headache diary)

  4-weeks

• Headache Duration

  Average number of headache hours in the last week (as registered in the headache diary)

  3-months

• Neck Disability Index (NDI)

  Neck pain and disability

  Baseline

• Neck Disability Index (NDI)

  Neck pain and disability

  1-week

• Neck Disability Index (NDI)

  Neck pain and disability

  4-weeks

• Neck Disability Index (NDI)

  Neck pain and disability

  3-months

Secondary Outcomes (5)

• Global Rating of Change (GROC)

  1-week

• Global Rating of Change (GROC)

  4-weeks

• Global Rating of Change (GROC)

  3-months

• Analgesic Use

  Baseline

• Analgesic Use

  3-months

Study Arms (2)

Thrust manipulation

EXPERIMENTAL

Other: Thrust Manipulation

Non-thrust mobilization and exercise

ACTIVE COMPARATOR

Other: Non-thrust Mobilization and Exercise

Interventions

Thrust Manipulation OTHER

Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.

Also known as: High-velocity low-amplitude thrust manipulation of the spine

Thrust manipulation

Non-thrust Mobilization and Exercise OTHER

Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.

Also known as: Non-thrust mobilization to cervical and thoracic spines, Cervical range of motion, strength, and postural exercises

Non-thrust mobilization and exercise

Eligibility Criteria

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

You may qualify if:

• Diagnosis of cervicogenic headache as defined by Cervicogenic Headache International Study Group criteria
• Headache frequency of at least one per week for a minimum of 3 months
• Minimum pain score (NPRS) of 2/10 and minimum disability score (NDI) of 10/50

You may not qualify if:

• Bilateral headaches
• Presence of any of the following atherosclerotic risk factors: hypertension, diabetes, heart disease, stroke, transient ischemic attack, peripheral vascular disease, smoking, hypercholesterolemia or hyperlipidemia
• Red flags noted in the patient's Neck Medical Screening Questionnaire (i.e. tumor, fracture, metabolic diseases, RA, osteoporosis, prolonged history of steroid use, etc.)
• History of whiplash injury within the last 6 weeks
• Diagnosis of cervical spinal stenosis
• Bilateral upper extremity symptoms
• Evidence of central nervous system involvement, to include hyperreflexia, sensory disturbances in the hand, intrinsic muscle wasting of the hands, unsteadiness during walking, nystagmus, loss of visual acuity, impaired sensation of the face, altered taste, the presence of pathological reflexes (i.e. positive Hoffman's and/or Babinski reflexes)
• Two or more positive neurologic signs consistent with nerve root compression, including any two of the following:
• Muscle weakness involving a major muscle group of the upper extremity.
• Diminished upper extremity deep tendon reflex of the biceps, brachioradialis, triceps or superficial flexors
• Diminished or absent sensation to pinprick in any upper extremity dermatome
• Prior surgery to the neck or thoracic spine.
• Involvement in litigation or worker's compensation regarding their neck pain and/or headaches.
• Physical therapy or chiropractic treatment for neck pain or headache in the 3 months before baseline examination.
• Any condition that might contraindicate spinal manipulative therapy

Sponsors & Collaborators

• Alabama Physical Therapy & Acupuncture: lead
• Long Island University: collaborator

Study Sites (1)

Alabama Physical Therapy & Acupuncture

Montgomery, Alabama, 36117, United States

Location

Related Publications (2)

• Dunning JR, Cleland JA, Waldrop MA, Arnot CF, Young IA, Turner M, Sigurdsson G. Upper cervical and upper thoracic thrust manipulation versus nonthrust mobilization in patients with mechanical neck pain: a multicenter randomized clinical trial. J Orthop Sports Phys Ther. 2012 Jan;42(1):5-18. doi: 10.2519/jospt.2012.3894. Epub 2011 Sep 30.

  PMID: 21979312 BACKGROUND

• Dunning JR, Butts R, Mourad F, Young I, Fernandez-de-Las Penas C, Hagins M, Stanislawski T, Donley J, Buck D, Hooks TR, Cleland JA. Upper cervical and upper thoracic manipulation versus mobilization and exercise in patients with cervicogenic headache: a multi-center randomized clinical trial. BMC Musculoskelet Disord. 2016 Feb 6;17:64. doi: 10.1186/s12891-016-0912-3.

  PMID: 26852024 DERIVED

MeSH Terms

Conditions

Post-Traumatic Headache; Headache; Neck Pain; Motor Activity

Interventions

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)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Marshall Hagins, PT, PhD

  Long Island University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2012
• First Posted: April 19, 2012
• Study Start: April 1, 2012
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: November 14, 2014

Record last verified: 2014-11

Locations

US (1)