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Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
This study has been completed.
Sponsor:
University Hospital, Akershus
Collaborators:
Norwegian Foundation for Health and Rehabilitation
Norwegian Chiropractic Association
Information provided by (Responsible Party):
Aleksander Chaibi, University Hospital, Akershus
ClinicalTrials.gov Identifier:
NCT01687881
First received: September 11, 2012
Last updated: December 30, 2015
Last verified: December 2015
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Purpose
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 | Intervention | Phase |
|---|---|---|
| Cervicogenic Headache | Other: Chiropractic Other: Sham Chiropractic | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Single Group Assignment Masking: Double Blind (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. |
Resource links provided by NLM:
Further study details as provided by Aleksander Chaibi, University Hospital, Akershus:
Primary Outcome Measures:
- Number of headache days [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
- 25% reduction in number of headache days between active treatment and sham.
- 25% reduction in number of headache days between active treatment and control group.
Secondary Outcome Measures:
- Headache duration [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
- 25% reduction in headache duration in hours between active treatment and sham.
- 25% reduction in headache duration in hours between active treatment and control group.
- Self reported VAS [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
- 25% self-reported improvement on VAS between active treatment and sham.
- 25% self-reported improvement on VAS between active treatment and control group.
- Headache index [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
- 25% reduction in headache index (frequency x duration x intensity) between active treatment and sham.
- 25% reduction in headache index between active treatment and control group.
- Headache medication [ Time Frame: Change from baseline to post-treatment, 3, 6, 12 months follow-up ]
- 50% reduction in headache medication between active treatment and sham.
- 50% reduction in headache medication between active treatment and control group.
Other Outcome Measures:
- 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.
| Enrollment: | 19 |
| Study Start Date: | September 2012 |
| Study Completion Date: | May 2014 |
| Primary Completion Date: | May 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Show Detailed Description
Eligibility| 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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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687881
Please refer to this study by its ClinicalTrials.gov identifier: NCT01687881
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
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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 ) |
| Study First Received: | September 11, 2012 |
| Last Updated: | December 30, 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 |
ClinicalTrials.gov processed this record on July 21, 2017