MedDataX Logo

Spinal Manipulation for Treatment of Chronic Headaches

NCT ID: NCT00246350

Last Updated: 2010-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-07-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Headache Disorders

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Headaches Spinal manipulation Massage chiropractic

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

8 light massage treatments

Group Type ACTIVE_COMPARATOR

massage

Intervention Type PROCEDURE

8 light massage treatments and hot pack

2

16 light massage treatments

Group Type ACTIVE_COMPARATOR

massage

Intervention Type PROCEDURE

16 light massage treatments and hot packs

3

8 spinal manipulation treatments

Group Type EXPERIMENTAL

spinal manipulation

Intervention Type PROCEDURE

8 high velocity, low amplitude spinal manipulation treatments and hot pack

4

16 spinal manipulation treatments

Group Type EXPERIMENTAL

Spinal manipulation

Intervention Type PROCEDURE

16 high velocity, low amplitude spinal manipulation treatments and hot pack

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

massage

8 light massage treatments and hot pack

Intervention Type PROCEDURE

massage

16 light massage treatments and hot packs

Intervention Type PROCEDURE

spinal manipulation

8 high velocity, low amplitude spinal manipulation treatments and hot pack

Intervention Type PROCEDURE

Spinal manipulation

16 high velocity, low amplitude spinal manipulation treatments and hot pack

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* History of cervicogenic headaches

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role collaborator

University of Western States

OTHER

Sponsor Role lead

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Mitchell Haas, DC

Role: PRINCIPAL_INVESTIGATOR

University of Western States

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Western States Chiropractic College

Portland, Oregon, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type BACKGROUND
PMID: 15614241 (View on PubMed)

Haas 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.

Reference Type RESULT
PMID: 19837005 (View on PubMed)

Haas 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.

Reference Type RESULT
PMID: 20114095 (View on PubMed)

Haas 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.

Reference Type RESULT
PMID: 20497573 (View on PubMed)

Vavrek 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.

Reference Type RESULT
PMID: 20605552 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

R21AT002324

Identifier Type: NIH

Identifier Source: secondary_id

View Link

R21AT002324

Identifier Type: NIH

Identifier Source: org_study_id

View Link