Manual Therapy and Exercise in Patients With Cervicogenic Headache

Effect of Upper Cervical and Upper Thoracic Thrust Manipulation Versus Mobilization and Exercise in Patients With Cervicogenic Headache

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.

Study Overview

• Status: Completed
• Conditions: Cervicogenic Headache
• Intervention / Treatment: Other: Thrust Manipulation; Other: Non-thrust Mobilization and Exercise

Detailed Description

Patients with cervicogenic headache will be randomized to receive 6-8 sessions over 2-4 weeks of either: (1) upper cervical and upper thoracic thrust manipulation, or (2) upper cervical and upper thoracic non-thrust mobilization and range of motion, strength and postural exercises.

• Study Type: Interventional
• Enrollment (Anticipated): 112
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Montgomery, Alabama, United States, 36117
      • Alabama Physical Therapy & Acupuncture

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thrust manipulation	Other: Thrust Manipulation; Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.; Other Names: High-velocity low-amplitude thrust manipulation of the spine
Active Comparator: Non-thrust mobilization and exercise	Other: Non-thrust Mobilization and Exercise; Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.; Other Names: Non-thrust mobilization to cervical and thoracic spines; Cervical range of motion, strength, and postural exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global Rating of Change (GROC)	Perceived improvement.	1-week
Global Rating of Change (GROC)	Perceived improvement.	4-weeks
Global Rating of Change (GROC)	Perceived improvement.	3-months
Analgesic Use	Analgesic (medication intake) use per day (as registered in the headache diary).	Baseline
Analgesic Use	Analgesic (medication intake) use per day (as registered in the headache diary).	3-months

Collaborators and Investigators

• Sponsor: Alabama Physical Therapy & Acupuncture
• Collaborators: Long Island University
• Investigators: Study Chair: Marshall Hagins, PT, PhD, Long Island University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): August 1, 2014

Study Registration Dates

• First Submitted: April 16, 2012
• First Submitted That Met QC Criteria: April 17, 2012
• First Posted (Estimate): April 19, 2012

Study Record Updates

• Last Update Posted (Estimate): November 14, 2014
• Last Update Submitted That Met QC Criteria: November 12, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: Exercise; Headache; Neck Pain; Mobilization; Manipulation; Cervicogenic
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Headache Disorders; Headache Disorders, Secondary; Headache; Post-Traumatic Headache
• Other Study ID Numbers: 12/01-006