NCT01620905

Brief Summary

Cervical spine manipulation has been shown to be helpful for some patients with neck pain. This study sought to determine factors which were predictive of which patients with neck pain would benefit from manipulation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2008

Typical duration 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

November 1, 2008

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

June 13, 2012

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 15, 2012

Completed
Last Updated

May 12, 2016

Status Verified

May 1, 2016

Enrollment Period

2.6 years

First QC Date

June 13, 2012

Last Update Submit

May 10, 2016

Conditions

Mechanical Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Global Rating of Change Scale

    15 point likert scale rating perceived recovery

    48 hours post intervention

Secondary Outcomes (2)

  • Numeric Pain Rating Scale

    48 hours and 96 hours post intervention

  • Neck Disability Index

    48 hours and 96 hours post intervention

Study Arms (1)

Cervical spine manipulation

EXPERIMENTAL

Subjects received cervical spine manipulation

Procedure: Manipulation

Interventions

ManipulationPROCEDURE

Single level cervical spine joint manipulation

Cervical spine manipulation

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age 18 to 60 years
  • primary report of neck pain with or without unilateral upper extremity symptoms
  • baseline neck disability index score of 10 points (out of 50) or greater

You may not qualify if:

  • any medical red flags suggesting that the etiology of symptoms might be nonmusculoskeletal
  • diagnosis of cervical spinal stenosis (as identified in the patients' medical intake form)
  • bilateral upper extremity symptoms
  • evidence of central nervous system involvement
  • history of whiplash injury within 6 weeks of the examination
  • pending legal action regarding their neck pain
  • or more positive neurologic signs consistent with nerve root compression (changes in sensation, myotomal weakness, or decreased deep tendon reflexes)
  • any history of cervical spine surgery, rheumatoid arthritis, osteoporosis, osteopenia, or ankylosing spondylitis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UNLV PT Department

Las Vegas, Nevada, 89154, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

June 13, 2012

First Posted

June 15, 2012

Study Start

November 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

May 12, 2016

Record last verified: 2016-05

Locations

US(1)