Cervicogenic Headache Dose-Response (CGH D-R)

University of Western States

Status and phase: Completed; Phase 2; Phase 1

Conditions: Cervicogenic Headache

Treatments: Other: Spinal Manipulation; Other: Light Massage

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01530321

R01AT006330

Details and patient eligibility

About

This study will determine the number of visits to a chiropractor for spinal manipulation and light massage necessary for the optimal relief of cervicogenic headache (headache with associated neck pain). Effectiveness of care will also be determined.

Enrollment: 256 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic cervicogenic headache
• threshold pain level
• threshold headache frequency
• independently ambulatory
• English literate
• candidate for spinal manipulation

Exclusion criteria

• contraindication to thrust spinal manipulation or massage
• most other headache types
• Recent manual/exercise therapy from licensed provider for head/neck
• threshold pain medication use
• pregnancy
• involvement with another pain study
• suspicion of unmanaged depression
• most cancers
• hypertension (at least stage II)
• complicating neurological/spinal conditions
• pre-randomization noncompliance or cannot/will not comply with protocols
• health-related litigation, claims, or disability compensation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

256 participants in 4 patient groups

High dose spinal manipulation

Experimental group

Description:

18 visits for spinal manipulation

Treatment:

Other: Spinal Manipulation

Moderate dose spinal manipulation

Experimental group

Description:

12 visits for spinal manipulation and 6 visits for light massage

Treatment:

Other: Light Massage

Other: Spinal Manipulation

Low dose spinal manipulation

Experimental group

Description:

6 visits for spinal manipulation and 12 visits for light massage

Treatment:

Other: Light Massage

Other: Spinal Manipulation

High dose massage

Other group

Description:

18 visits for light massage

Treatment:

Other: Light Massage