Manual Therapy and Exercise in Patients With Cervicogenic Headache

Not Applicable

Completed

• Conditions: Cervicogenic Headache
• Interventions: Other: Thrust Manipulation; Other: Non-thrust Mobilization and Exercise

• Registration Number: NCT01580280
• Lead Sponsor: Alabama Physical Therapy & Acupuncture

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.

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 Timeline

• Study Start: 2012-04
• Study First Submitted: 2012-04-16
• Study First Submitted QC: 2012-04-17
• Study First Posted: 2012-04-19
• Primary Completion: 2014-08
• Study Completion: 2014-08
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-12
• Last Update Posted: 2014-11-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 112

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thrust manipulation	Thrust Manipulation	-
Non-thrust mobilization and exercise	Non-thrust Mobilization and Exercise	-

Primary Outcome Measures

Name	Time	Method
Neck Disability Index (NDI)	3-months	Neck pain and disability
Headache Frequency	3-months	The number of headache days in the past week (as registered in headache diary)
Headache Duration	3-months	Average number of headache hours in the last week (as registered in the headache diary)
Headache Intensity	3-months	Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.

Secondary Outcome Measures

Name	Time	Method
Analgesic Use	3-months	Analgesic (medication intake) use per day (as registered in the headache diary).
Global Rating of Change (GROC)	3-months	Perceived improvement.

Trial Locations

Locations (1)

Alabama Physical Therapy & Acupuncture; 🇺🇸 Montgomery, Alabama, United States