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Cervicogenic Headache Dose-Response (CGH D-R)

U

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

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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