Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

This study will highlight and validate chiropractic spinal manipulative therapy (CSMT) for cervicogenic headache (CEH). If the method proves to be effective, it will provide a new non-pharmacological treatment option for CEH. This is especially important since pharmacological management has minor effect in CEH, and alternative treatment options are warranted. The applied methodology of the study will aim towards the highest possible research standards. This international study is a collaboration between Akershus University Hospital, Innlandet Hospital and University of Oslo (UiO), Norway and Macquarie University, Australia. The multidisciplinary professional backgrounds are physiotherapy, chiropractic and medicine. By increasing the methodological quality of the investigators research to a very high level, the investigators see the method to work as a guide to increase the quality of chiropractic research in the future, as previous randomized clinical trials (RCTs) of CEH used methodology showing room for improvement.

Study hypothesis:

CSMT using the Gonstead method reduces days with CEH by at least 25% as compared to placebo (sham manipulation, i.e. broad non-specific contact, non-directional, low velocity and low amplitude) and no intervention (control group).

Condition or disease	Intervention/treatment	Phase
Cervicogenic Headache	Other: Chiropractic; Other: Sham Chiropractic	Phase 3

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Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	19 participants
Allocation:	Randomized
Intervention Model:	Single Group Assignment
Masking:	Double (Participant, Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache? A Randomized Controlled Clinical Trial.
Study Start Date :	September 2012
Actual Primary Completion Date :	May 2014
Actual Study Completion Date :	May 2014

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Sham Comparator: Sham Chiropractic; Sham Chiropractic manipulative therapy.	Other: Sham Chiropractic; Sham manipulation
No Intervention: Control group; No intervention: Control group.
Active Comparator: Chiropractic Spinal Manipulative Therapy; Active intervention: Chiropractic Spinal Manipulative Therapy	Other: Chiropractic; Chiropractic Spinal Manipulative Therapy

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Number of headache days [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
   1. 25% reduction in number of headache days between active treatment and sham.
   2. 25% reduction in number of headache days between active treatment and control group.

Secondary Outcome Measures :

1. Headache duration [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
   1. 25% reduction in headache duration in hours between active treatment and sham.
   2. 25% reduction in headache duration in hours between active treatment and control group.
2. Self reported VAS [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
   1. 25% self-reported improvement on VAS between active treatment and sham.
   2. 25% self-reported improvement on VAS between active treatment and control group.
3. Headache index [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
   1. 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
   2. 25% reduction in headache index between active treatment and control group.
4. Headache medication [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
   1. 50% reduction in headache medication between active treatment and sham.
   2. 50% reduction in headache medication between active treatment and control group.

Other Outcome Measures:

1. Sub-analysis on x-ray findings [ Time Frame: Change formbaseline to post-treatment, 3, 6, 12 months follow-up ]
   Sub-analysis will be done on participants with structural deformities vs. normal x-ray findings.

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

• CEH according to at least three major criteria of the CHISG not including occipital nerve blockage
• Age 18-70 years

Exclusion Criteria:

• Contraindication to spinal manipulation
• Chiropractic treatment within the last 12 months
• Radiculopathy
• Depression
• Pregnancy
• Participants whom become pregnant during the migraine trial will also be excluded from analysis from the time of pregnancy
• Participants who change their prophylactic medical regime for headaches will be excluded in the analysis from the time of change

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Norway
Research Centre, Akershus University Hospital
Lørenskog, Norway, 1478

Sponsors and Collaborators

University Hospital, Akershus

Norwegian Foundation for Health and Rehabilitation

Norwegian Chiropractic Association

Investigators

Study Director:	Michael B Russell, Professor	Head and Neck research Group, Research Centre, Akershus University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Chaibi A, Russell MB. Manual therapies for cervicogenic headache: a systematic review. J Headache Pain. 2012 Jul;13(5):351-9. doi: 10.1007/s10194-012-0436-7. Epub 2012 Mar 30. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Chaibi A, Knackstedt H, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a single-blinded, placebo, randomized controlled trial. BMC Res Notes. 2017 Jul 24;10(1):310. doi: 10.1186/s13104-017-2651-4.

Chaibi A, Benth JŠ, Tuchin PJ, Russell MB. Chiropractic spinal manipulative therapy for cervicogenic headache: a study protocol of a single-blinded placebo-controlled randomized clinical trial. Springerplus. 2015 Dec 16;4:779. doi: 10.1186/s40064-015-1567-5. eCollection 2015.

Responsible Party:	Aleksander Chaibi, PhD student, University Hospital, Akershus
ClinicalTrials.gov Identifier:	NCT01687881 History of Changes
Other Study ID Numbers:	CEH-K34KSF-AHUS; 2829002 ( Other Identifier: Research Centre, Akershus University Hospital )
First Posted:	September 19, 2012
Last Update Posted:	December 31, 2015
Last Verified:	December 2015

Keywords provided by Aleksander Chaibi, University Hospital, Akershus:

Chiropractic; Manipulative therapy; Cervicogenic headache

Additional relevant MeSH terms:

Headache; Post-Traumatic Headache; Pain; Neurologic Manifestations; Nervous System Diseases	Signs and Symptoms; Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases