Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00246350
Other study ID # R21AT002324
Secondary ID R21AT002324
Status Completed
Phase Phase 2
First received September 13, 2005
Last updated November 19, 2010
Start date September 2004
Est. completion date July 2007

Study information

Verified date November 2010
Source University of Western States
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 80
Est. completion date July 2007
Est. primary completion date July 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
massage
8 light massage treatments and hot pack
massage
16 light massage treatments and hot packs
spinal manipulation
8 high velocity, low amplitude spinal manipulation treatments and hot pack
Spinal manipulation
16 high velocity, low amplitude spinal manipulation treatments and hot pack

Locations

Country Name City State
United States Western States Chiropractic College Portland Oregon

Sponsors (2)

Lead Sponsor Collaborator
University of Western States National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (5)

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: 10.1 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modified Von Korff pain scale for headaches
Secondary Modified Von Korff disability scale for headaches
Secondary Number of cervicogenic headaches
Secondary general physical and mental health status
Secondary patient satisfaction
Secondary neck pain
See also
  Status Clinical Trial Phase
Not yet recruiting NCT03632928 - Day to Day Variation of Pressure Pain Threshold and Muscle Hardness
Completed NCT05404113 - Sustained Natural Apophyseal Glide and Deep Friction Massage in Patients With Cervicogenic Headache N/A
Recruiting NCT03416114 - RegistRare: a Retro-prospective Registry of Rare Primary Headaches in Italian Tertiary Headache Centres N/A
Enrolling by invitation NCT04976985 - Osteopathic Manipulative Treatment and Migraine Headaches N/A
Completed NCT05153876 - An Open Internet-based Survey and Natural Language Processing Project Analysing Written Monologues by Headache Patients
Recruiting NCT06041997 - Smartphone Use Restriction as Treatment of Primary Headache N/A
Active, not recruiting NCT04936321 - Intervention for Sleep and Pain in Youth: A Randomized Controlled Trial N/A
Completed NCT04220580 - Multiomics After Cold Pressor Test of People Who Are Unable to Have Headache N/A
Completed NCT03385174 - Carbon Monoxide Headache Triggering Properties as Well as Effects on the Brain's Vessels and Blood Flow N/A
Completed NCT03137147 - Intervention for Sleep and Pain in Youth N/A
Completed NCT02910921 - Individualized Prediction of Migraine Attacks Using a Mobile Phone App and Fitbit
Recruiting NCT05619354 - Validity and Reliability of the Dutch HDI
Recruiting NCT06206772 - Resting State Functional Connectivity in Cluster Headache
Terminated NCT02624661 - Glycerol Block of the Trigeminal Ganglion in Trigeminal Neuralgia Using a New Neuronavigation-based Surgical Technique Phase 1/Phase 2
Completed NCT02662972 - Botulinum Toxin Type A Block of the Sphenopalatine Ganglion in Trigeminal Neuralgia. Safety Issues. Phase 1/Phase 2
Completed NCT05381012 - Fibromyalgia Syndrome on Patients With Chronic Migraine N/A
Completed NCT04891848 - Assessment of Inflammation in Primary Headaches
Recruiting NCT04715685 - Mind Body Balance for Pediatric Migraine N/A
Completed NCT00457496 - Effectiveness of a Cognitive and Physical Intervention to Reduce Head and Muscle Pain in Working Communities Phase 3
Recruiting NCT05475769 - NUMITOR Study: Nummular Headache Iberian Study on the Treatments and Outcomes in Real-World Setting