Headache DisordersPhase 2NCT00246350
Spinal Manipulation for Treatment of Chronic Headaches
A Phase 2 study testing massage and spinal manipulation in people with Headache Disorders, run by University of Western States at 1 site in United States.
Trial summary
This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Headache Disorders
- What is being tested?
- massage and spinal manipulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2004to Jul 2007
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of cervicogenic headaches
Who cannot join
- Contraindications to spinal manipulation or massage
- Use of chiropractic or therapeutic massage care prior to study entry
- Use of any prophylactic prescription medication
- Involved in any type of lawsuit prior to study entry
- Headaches with several different causes
Trial locations and contacts
1 site in 1 country.
United States1 site
Western States Chiropractic College
Portland, Oregon, 97230
About this study
Official title: Dose-Response of Manipulation for Chronic Headache
This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.
Read the detailed description
Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits.
Participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study.
- Conditions
- Headache Disorders
- Being tested
- massage, spinal manipulation
- Keywords
- Headaches, Spinal manipulation, Massage, chiropractic
- Medical subject headings
- Headache Disorders, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
massageProcedure or surgery
8 light massage treatments and hot pack
massageProcedure or surgery
16 light massage treatments and hot packs
spinal manipulationProcedure or surgery
8 high velocity, low amplitude spinal manipulation treatments and hot pack
Spinal manipulationProcedure or surgery
16 high velocity, low amplitude spinal manipulation treatments and hot pack
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | 8 light massage treatments Receives: Procedure: massage |
| 2 | Active comparator | 16 light massage treatments Receives: Procedure: massage |
| 3 | Experimental | 8 spinal manipulation treatments Receives: Procedure: spinal manipulation |
| 4 | Experimental | 16 spinal manipulation treatments Receives: Procedure: Spinal manipulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modified Von Korff pain scale for headaches
Secondary outcomes (5)
Modified Von Korff disability scale for headaches
Number of cervicogenic headaches
general physical and mental health status
patient satisfaction
neck pain
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startSep 2004
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Headache DisordersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Western States
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Investigators
- Mitchell Haas, DC, Principal investigator, University of Western States
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246350
- Sponsor's protocol ID
- R21AT002324
- Other IDs
- R21AT002324
- Status last verified
- Nov 2010
- First submitted
- 13 Sep 2005
- Last updated
- 22 Nov 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Haas M, Groupp E, Aickin M, Fairweather A, Ganger B, Attwood M, Cummins C, Baffes L. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):547-53. doi: 10.1016/j.jmpt.2004.10.007.
PubMed 15614241Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002.
PubMed 19837005Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13. doi: 10.1016/j.jmpt.2009.11.007.
PubMed 20114095Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9. doi: 10.1186/1746-1340-18-9.
PubMed 20497573Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48. doi: 10.1016/j.jmpt.2010.05.004.
PubMed 20605552
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-Response of Manipulation for Chronic Headache
- ClinicalTrials.gov ID
- NCT00246350
- Acronym / sponsor ID
- R21AT002324
- Conditions
- Headache Disorders
- Keywords
- Headaches, Spinal manipulation, Massage, chiropractic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of Western StatesUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Sep 2004
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will determine the effectiveness of spinal manipulation in reducing pain in people with chronic headaches accompanied by neck pain. This study will also determine the number of spinal manipulation treatments necessary for optimal pain relief.
Detailed description
Spinal manipulation is the signature therapy of chiropractic care involving manual adjustment of joints in the neck and back. Data indicate that spinal manipulation is an effective treatment for back pain and chronic headaches, particularly cervicogenic headaches, which are caused by problems in the cervical spine. However, studies that have determined the optimal frequency and duration of spinal manipulation treatment are limited. This study will determine the feasibility of conducting a large spinal manipulation clinical trial. This study will also determine the effectiveness of spinal manipulation in treating cervicogenic headaches and neck pain and the optimal number of treatments necessary to sustain spinal manipulation benefits.
Participants will be randomly assigned to receive weekly sessions of either spinal manipulation or light massage treatments for 8 to 16 weeks. Self-report scales will be used to assess participants' headache frequency, pain, satisfaction with treatment, and overall physical and mental health. Assessments will occur at study entry, at the end of each week, and at the end of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Procedure: massage8 light massage treatments |
| 2 | Active comparator | Procedure: massage16 light massage treatments |
| 3 | Experimental | Procedure: spinal manipulation8 spinal manipulation treatments |
| 4 | Experimental | Procedure: Spinal manipulation16 spinal manipulation treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- History of cervicogenic headaches
Key exclusion criteria (5 listed)
- Contraindications to spinal manipulation or massage
- Use of chiropractic or therapeutic massage care prior to study entry
- Use of any prophylactic prescription medication
- Involved in any type of lawsuit prior to study entry
- Headaches with several different causes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| massage8 light massage treatments and hot pack | Procedure or surgery | 1 |
| massage16 light massage treatments and hot packs | Procedure or surgery | 2 |
| spinal manipulation8 high velocity, low amplitude spinal manipulation treatments and hot pack | Procedure or surgery | 3 |
| Spinal manipulation16 high velocity, low amplitude spinal manipulation treatments and hot pack | Procedure or surgery | 4 |
Primary outcome
Modified Von Korff pain scale for headaches
5 secondary outcomes
Modified Von Korff disability scale for headaches
Number of cervicogenic headaches
general physical and mental health status
patient satisfaction
neck pain
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2010.
- Background: PubMed 15614241Haas M, Groupp E, Aickin M, Fairweather A, Ganger B, Attwood M, Cummins C, Baffes L. Dose response for chiropractic care of chronic cervicogenic headache and associated neck pain: a randomized pilot study. J Manipulative Physiol Ther. 2004 Nov-Dec;27(9):547-53. doi: 10.1016/j.jmpt.2004.10.007.
- Results publication: PubMed 19837005Haas M, Spegman A, Peterson D, Aickin M, Vavrek D. Dose response and efficacy of spinal manipulation for chronic cervicogenic headache: a pilot randomized controlled trial. Spine J. 2010 Feb;10(2):117-28. doi: 10.1016/j.spinee.2009.09.002.
- Results publication: PubMed 20114095Haas M, Aickin M, Vavrek D. A preliminary path analysis of expectancy and patient-provider encounter in an open-label randomized controlled trial of spinal manipulation for cervicogenic headache. J Manipulative Physiol Ther. 2010 Jan;33(1):5-13. doi: 10.1016/j.jmpt.2009.11.007.
- Results publication: PubMed 20497573Haas M, Schneider M, Vavrek D. Illustrating risk difference and number needed to treat from a randomized controlled trial of spinal manipulation for cervicogenic headache. Chiropr Osteopat. 2010 May 24;18:9. doi: 10.1186/1746-1340-18-9.
- Results publication: PubMed 20605552Vavrek D, Haas M, Peterson D. Physical examination and self-reported pain outcomes from a randomized trial on chronic cervicogenic headache. J Manipulative Physiol Ther. 2010 Jun;33(5):338-48. doi: 10.1016/j.jmpt.2010.05.004.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mitchell Haas, DC principal investigator
University of Western States
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing massage and spinal manipulation in people with Headache Disorders, run by University of Western States at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Nov 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Von Korff pain scale for headaches. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246350, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Nov 2010; AzTrials last refreshed its copy on 7 Nov 2026.