Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
Primary Purpose
Cervicogenic Headache
Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Chiropractic
Sham Chiropractic
Sponsored by
About this trial
This is an interventional treatment trial for Cervicogenic Headache focused on measuring Chiropractic, Manipulative therapy, Cervicogenic headache
Eligibility 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
Sites / Locations
- Research Centre, Akershus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Sham Comparator
No Intervention
Active Comparator
Arm Label
Sham Chiropractic
Control group
Chiropractic Spinal Manipulative Therapy
Arm Description
Sham Chiropractic manipulative therapy.
No intervention: Control group.
Active intervention: Chiropractic Spinal Manipulative Therapy
Outcomes
Primary Outcome Measures
Number of headache days
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
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
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
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
50% reduction in headache medication between active treatment and sham.
50% reduction in headache medication between active treatment and control group.
Full Information
NCT ID
NCT01687881
First Posted
September 11, 2012
Last Updated
January 9, 2019
Sponsor
University Hospital, Akershus
Collaborators
Norwegian Foundation for Health and Rehabilitation, Norwegian Chiropractic Association
1. Study Identification
Unique Protocol Identification Number
NCT01687881
Brief Title
Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
Official Title
Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache? A Randomized Controlled Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
May 2014 (Actual)
Study Completion Date
May 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Hospital, Akershus
Collaborators
Norwegian Foundation for Health and Rehabilitation, Norwegian Chiropractic Association
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
Cervicogenic headache (CEH) is a symptomatic headache characterized by chronic unilateral headache and symptoms and signs of neck involvement. CEH is often worsened by neck movement, sustained awkward head position, external pressure over the upper cervical or occipital region on the symptomatic side. Abolition of the headache following diagnostic anesthetic blocks of cervical structures or local factors in neck give evidence that the pain is attributed to a neck disorder or lesion. The prevalence of CEH is 0.2% in the general population of Akershus County, i.e. 9,000 Norwegians have CEH. However, the prevalence varies between 0.4-4.1% in studies applying less rigorous diagnostic criteria. The efficacy of pharmacological management in CEH is poor. Patients suffering from CEH are commonly treated with CSMT, but the methodology has one or more shortcomings in all studies. In addition, the RCTs mostly included participant with infrequent CEH and did not follow the recommended clinical guidelines by the International Headache Society (IHS) of intervention of at least three months. An analysis of the literature as well as a recent pilot study suggests that CSMT has an effect on headache intensity and duration, and medication intake. However, a randomized controlled clinical trial with high methodological quality on CEH still remains to be conducted.
The RCT is single blinded, placebo-controlled trial of CSMT using the Gonstead method vs. sham manipulation and control group. If the treatment shows to be effective, the participants whom receive sham manipulation or control will be offered true intervention after the follow-up period and free of charge. This study will follow the recommendations set by the clinical trial guidelines from the IHS, while the methodological quality control will in general follow previous suggested criteria and the CONSORT statements.
Patients will be recruited through Akershus University Hospital and Innlandet Hospital, Norway as well as through media advertising in Akershus and Oslo County. The diagnose is set by a chiropractor and a neurologist with experience in headache.
The clinical trials consist of three stages: Run-in, intervention (treatment) and follow-up.
One month of base line data collection where participants will fill-in a diagnostic headache diary. Baseline demographics and clinical characteristics will be presented in tables with mean and standard deviation (SD) for each group.
The participants will be randomized by drawing prepared sealed lots. Each lot includes three different interventions, i.e active treatment, sham manipulation and control group. The first three participants will draw from the same lot until all three interventions are used. The next lot with three interventions is then followed by the next three participants.
The RCTs will be conducted by an experienced chiropractor. Active treatment consists of CSMT using the Gonstead method. A specific contact, high velocity, low amplitude, short lever, with no recoil post adjustment directed to spinal biomechanical dysfunction diagnosed by standard chiropractic tests.
Follow-up at 3, 6 and 12 months post-treatment. During this period participants continue to fill in a diagnostic headache diary. The control group will also be included in this phase of the study.
The data will be analyzed with SPSS using standard statistical techniques.
The investigators based our calculation of sample size on migraine days from recent group comparison studies of topiramate (38). The investigators calculated that a sample size of 16 patients was required to detect a difference in mean reduction in monthly headache days of 2.5 with 80% power, with p=0.05 as level of significance, and assuming a common SD of 2.5 for active treatment and broad-based treatment groups.
Insurance is through "The Norwegian System of Compensation to Patients" (NPE) which is an independent national body, set up to process compensation claims from patients who have suffered an injury as a result of treatment under the Norwegian health service.
The Regional Committee for Medical Research Ethics (REK) in Norway and Norwegian Social Science Data Services approved the full PhD research protocol. The declaration of Helsinski is followed.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervicogenic Headache
Keywords
Chiropractic, Manipulative therapy, Cervicogenic headache
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sham Chiropractic
Arm Type
Sham Comparator
Arm Description
Sham Chiropractic manipulative therapy.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
No intervention: Control group.
Arm Title
Chiropractic Spinal Manipulative Therapy
Arm Type
Active Comparator
Arm Description
Active intervention: Chiropractic Spinal Manipulative Therapy
Intervention Type
Other
Intervention Name(s)
Chiropractic
Intervention Description
Chiropractic Spinal Manipulative Therapy
Intervention Type
Other
Intervention Name(s)
Sham Chiropractic
Intervention Description
Sham manipulation
Primary Outcome Measure Information:
Title
Number of headache days
Description
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.
Time Frame
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Secondary Outcome Measure Information:
Title
Headache duration
Description
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.
Time Frame
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Title
Self reported VAS
Description
25% self-reported improvement on VAS between active treatment and sham.
25% self-reported improvement on VAS between active treatment and control group.
Time Frame
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Title
Headache index
Description
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.
Time Frame
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Title
Headache medication
Description
50% reduction in headache medication between active treatment and sham.
50% reduction in headache medication between active treatment and control group.
Time Frame
Change from baseline to post-treatment, 3, 6, 12 months follow-up
Other Pre-specified Outcome Measures:
Title
Sub-analysis on x-ray findings
Description
Sub-analysis will be done on participants with structural deformities vs. normal x-ray findings.
Time Frame
Change formbaseline to post-treatment, 3, 6, 12 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael B Russell, Professor
Organizational Affiliation
Head and Neck research Group, Research Centre, Akershus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Research Centre, Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
12. IPD Sharing Statement
Citations:
PubMed Identifier
22460941
Citation
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.
Results Reference
background
PubMed Identifier
26697289
Citation
Chaibi A, Benth JS, 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.
Results Reference
background
PubMed Identifier
28738895
Citation
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.
Results Reference
result
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Is Chiropractic Spinal Manipulative Therapy an Efficient Treatment Option in Cervicogenic Headache
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