NCT01917071

Brief Summary

Hypothesis: There is no difference in directional specific manipulation of the thoracic spine for patients with neck pain. Patients seeking physical therapy for neck pain routinely have their thoracic spine manipulated. This study seeks to determine if directional limitations in the spine can be specifically determined and treated to decrease neck pain.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

August 2, 2013

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 6, 2013

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

July 28, 2015

Status Verified

August 1, 2013

Enrollment Period

1.4 years

First QC Date

August 2, 2013

Last Update Submit

July 27, 2015

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (1)

  • Neck Disability Index

    Objective, valid, reliable measure of function in patients with neck pain. Completed as a survey.

    2 weeks

Secondary Outcomes (1)

  • Neck Pain

    2 weeks

Study Arms (1)

Matched Group

EXPERIMENTAL

Receives thoracic spine manipulation in the direction of motion limitation.

Other: thoracic spine manipulation

Interventions

thoracic spine manipulationOTHER

a manual technique applied to the mid back to promote motion

Matched Group

Eligibility Criteria

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

You may qualify if:

  • Patients with Neck Pain; ages 18 - 60

You may not qualify if:

  • red flags: leg weakness, night pain, history of cancer, upper motor neuron signs, infection, tumors, osteoporosis, fracture (Boissonnault, 2011) (Cleland, 2004) history of whiplash within 6 weeks, cervical stenosis, CNS involvement, signs consistent with nerve root compression, previous surgery, pending legal action

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chatham University

Pittsburgh, Pennsylvania, 15221, United States

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Steve A Karas, DSc, PT

    Chatham University

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

August 2, 2013

First Posted

August 6, 2013

Study Start

August 1, 2013

Primary Completion

January 1, 2015

Study Completion

January 1, 2015

Last Updated

July 28, 2015

Record last verified: 2013-08

Locations

US(1)