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

NCT01687881 | Completed DMC

• 2 other identifiers: CEH-K34KSF-AHUS2829002
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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).

Conditions

Cervicogenic Headache

Keywords

Chiropractic; Manipulative therapy; Cervicogenic headache

Outcome Measures

Primary Outcomes (1)

• Number of headache days

  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.

  Change from baseline to post-treatment, 3, 6, 12 months follow-up

Secondary Outcomes (4)

• Headache duration

  Change from baseline to post-treatment, 3, 6, 12 months follow-up

• Self reported VAS

  Change from baseline to post-treatment, 3, 6, 12 months follow-up

• Headache index

  Change from baseline to post-treatment, 3, 6, 12 months follow-up

• Headache medication

  Change from baseline to post-treatment, 3, 6, 12 months follow-up

Other Outcomes (1)

• Sub-analysis on x-ray findings

  Change formbaseline to post-treatment, 3, 6, 12 months follow-up

Study Arms (3)

Sham Chiropractic

SHAM COMPARATOR

Sham Chiropractic manipulative therapy.

Other: Sham Chiropractic

Control group

NO INTERVENTION

No intervention: Control group.

Chiropractic Spinal Manipulative Therapy

ACTIVE COMPARATOR

Active intervention: Chiropractic Spinal Manipulative Therapy

Other: Chiropractic

Interventions

Chiropractic OTHER

Chiropractic Spinal Manipulative Therapy

Chiropractic Spinal Manipulative Therapy

Sham Chiropractic OTHER

Sham manipulation

Sham Chiropractic

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Akershus: lead
• Norwegian Foundation for Health and Rehabilitation: collaborator
• Norwegian Chiropractic Association: collaborator

Study Sites (1)

Research Centre, Akershus University Hospital

Lørenskog, 1478, Norway

Location

Related Publications (3)

• 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.

  PMID: 22460941 BACKGROUND

• 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.

  PMID: 26697289 BACKGROUND

• 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.

  PMID: 28738895 RESULT

MeSH Terms

Conditions

Post-Traumatic Headache

Interventions

Manipulation, Chiropractic

Condition Hierarchy (Ancestors)

Headache Disorders, Secondary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Complementary Therapies; Therapeutics

Study Officials

• Michael B Russell, Professor

  Head and Neck research Group, Research Centre, Akershus University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student

Study Record Dates

• First Submitted: September 11, 2012
• First Posted: September 19, 2012
• Study Start: September 1, 2012
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: January 10, 2019

Record last verified: 2019-01

Locations

NO (1)