Manual Therapy and Exercise in Patients With Cervicogenic Headache

Cervicogenic Headache Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01580280
• Other study ID #: 12/01-006
• Status: Completed
• Phase: N/A
• First received: April 16, 2012
• Last updated: November 12, 2014
• Start date: April 2012
• Est. completion date: August 2014

Study information

• Verified date: November 2014
• Source: Alabama Physical Therapy & Acupuncture
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 112
• Est. completion date: August 2014
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cervicogenic Headache
• Headache
• Post-Traumatic Headache

Intervention

Other:
• Thrust Manipulation
Upper cervical and upper thoracic thrust manipulation for 6-8 sessions over 2-4 weeks.
• Non-thrust Mobilization and Exercise
Upper cervical and upper thoracic non-thrust mobilization and exercise for 6-8 sessions over 2-4 weeks.

Locations

Country	Name	City	State
United States	Alabama Physical Therapy & Acupuncture	Montgomery	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
Alabama Physical Therapy & Acupuncture	Long Island University

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Headache Frequency	The number of headache days in the past week (as registered in headache diary)	Baseline	No
Primary	Headache Frequency	The number of headache days in the past week (as registered in headache diary)	1-week	No
Primary	Headache Frequency	The number of headache days in the past week (as registered in headache diary)	4-weeks	No
Primary	Headache Frequency	The number of headache days in the past week (as registered in headache diary)	3-months	No
Primary	Headache Intensity	Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.	Baseline	No
Primary	Headache Intensity	Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.	1-week	No
Primary	Headache Intensity	Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.	4-weeks	No
Primary	Headache Intensity	Average pain intensity as measured by the Numeric Pain Rating Scale (NPRS) per headache episode in the past week.	3-months	No
Primary	Headache Duration	Average number of headache hours in the last week (as registered in the headache diary)	Baseline	No
Primary	Headache Duration	Average number of headache hours in the last week (as registered in the headache diary)	1-week	No
Primary	Headache Duration	Average number of headache hours in the last week (as registered in the headache diary)	4-weeks	No
Primary	Headache Duration	Average number of headache hours in the last week (as registered in the headache diary)	3-months	No
Primary	Neck Disability Index (NDI)	Neck pain and disability	Baseline	No
Primary	Neck Disability Index (NDI)	Neck pain and disability	1-week	No
Primary	Neck Disability Index (NDI)	Neck pain and disability	4-weeks	No
Primary	Neck Disability Index (NDI)	Neck pain and disability	3-months	No
Secondary	Global Rating of Change (GROC)	Perceived improvement.	1-week	No
Secondary	Global Rating of Change (GROC)	Perceived improvement.	4-weeks	No
Secondary	Global Rating of Change (GROC)	Perceived improvement.	3-months	No
Secondary	Analgesic Use	Analgesic (medication intake) use per day (as registered in the headache diary).	Baseline	No
Secondary	Analgesic Use	Analgesic (medication intake) use per day (as registered in the headache diary).	3-months	No