Spinal Manipulation for Treatment of Chronic Headaches

University of Western States

Status and phase: Completed; Phase 2

Conditions: Headache Disorders

Treatments: Procedure: Spinal manipulation; Procedure: spinal manipulation; Procedure: massage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00246350

R21AT002324 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

80 participants in 4 patient groups

1

Active Comparator group

Description:

8 light massage treatments

Treatment:

Procedure: massage

Procedure: massage

2

Active Comparator group

Description:

16 light massage treatments

Treatment:

Procedure: massage

Procedure: massage

3

Experimental group

Description:

8 spinal manipulation treatments

Treatment:

Procedure: spinal manipulation

4

Experimental group

Description:

16 spinal manipulation treatments

Treatment:

Procedure: Spinal manipulation