NCT02356380

Brief Summary

To determine the affects of Physical Therapists clinical reasoning using thoracic spine mobilization for neck pain compared to a standard protocol.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 2, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 5, 2015

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 27, 2017

Status Verified

October 1, 2017

Enrollment Period

3.9 years

First QC Date

February 2, 2015

Last Update Submit

October 25, 2017

Conditions

Neck Pain

Outcome Measures

Primary Outcomes (3)

  • Neck Pain

    0-10 scale

    2 weeks

  • Neck Disability Index

    Assessment of function of neck using a valid and reliable written tool.

    2 weeks

  • Global Rating of Change

    A written scale assessing overall improvement

    2 weeks

Study Arms (1)

Mobilization

EXPERIMENTAL

Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.

Other: Mobilization Type

Interventions

Mobilization TypeOTHER

Group One: Mobilization Group: this group will receive grade 1,2,3,or 4 mobilization in prone based on the PT's clinical judgement. The treatment parameters will be recorded. Group Two: Grade 3-4 mobilization group: this group will receive a grade 3-4 mobilization, for 30 seconds form the first through sixth thoracic vertebrae.

Mobilization

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), 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

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Steve Karas, DSc

CONTACT

412 365 2798skaras@chatham.edu

Brett Windsor, PhD (c)

CONTACT

910-893-1723brettwindsor@gmail.com

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

February 2, 2015

First Posted

February 5, 2015

Study Start

January 1, 2015

Primary Completion

December 1, 2018

Study Completion

December 1, 2018

Last Updated

October 27, 2017

Record last verified: 2017-10

Locations

US(1)