NCT00429624

Brief Summary

The purpose of this study is to determine whether chiropractic manipulation or medical therapy is effective in the treatment of chronic neck pain.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 1994

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 1994

Completed
12.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2007

Completed
29 days until next milestone

First Submitted

Initial submission to the registry

January 30, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
Last Updated

February 5, 2013

Status Verified

January 1, 2007

Enrollment Period

12.3 years

First QC Date

January 30, 2007

Last Update Submit

February 4, 2013

Conditions

Neck Pain

Keywords

Neck PainChiropractic manipulationRandomized controlled trial

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index scale 0-30, clinically significant difference is a change greater than or equal to 5

Interventions

Chiropractic manipulationPROCEDURE
acetaminophenDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Neck pain for more than 3 months

You may not qualify if:

  • Cervical radiculopathy or myelopathy
  • Contraindications to cervical manipulation: metastatic cancer, coagulation disorder, cervical spine abnormalities, neuromuscular disease
  • Medical contraindications: uncontrolled hypertension, active coronary artery disease, history of cerebral vascular disease, alcohol or drug dependency, acetaminophen allergy
  • Active litigation involving neck pain
  • Medical or Chiropractic treatment within the past 3 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Colorado Health Sciences Center

Denver, Colorado, 80262, United States

Location

MeSH Terms

Conditions

Neck Pain

Interventions

Manipulation, ChiropracticAcetaminophen

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Musculoskeletal ManipulationsComplementary TherapiesTherapeuticsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • David J Tanaka, M.D.

    University of Colorado, Denver

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 30, 2007

First Posted

February 1, 2007

Study Start

September 1, 1994

Primary Completion

January 1, 2007

Study Completion

January 1, 2007

Last Updated

February 5, 2013

Record last verified: 2007-01

Locations

US(1)