Spinal Manipulation for Treatment of Chronic Headaches

Phase 2

Completed

• Conditions: Headache Disorders
• Interventions: Procedure: massage; Procedure: Spinal manipulation

• Registration Number: NCT00246350
• Lead Sponsor: University of Western States

Brief 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.

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 Timeline

• Study Start: 2004-09
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2010-11
• Last Update Submitted: 2010-11-19
• Last Update Posted: 2010-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2	massage	16 light massage treatments
3	Spinal manipulation	8 spinal manipulation treatments
1	massage	8 light massage treatments
4	Spinal manipulation	16 spinal manipulation treatments

Primary Outcome Measures

Name	Time	Method
Modified Von Korff pain scale for headaches

Secondary Outcome Measures

Name	Time	Method
Modified Von Korff disability scale for headaches
Number of cervicogenic headaches
general physical and mental health status
patient satisfaction
neck pain

Trial Locations

Locations (1)

Western States Chiropractic College; 🇺🇸 Portland, Oregon, United States