NCT01760590

Brief Summary

The purpose of this research is to compare the effects of two commonly used, safe, thoracic spine grade 1-4 and grade 5 mobilization to the thoracic spine on cervical spine pain in individuals with nontraumatic cervical pain. The immediate effects of thoracic spine mobilization have been shown to facilitate greater range of motion increases in the cervical spine and greater pain decreases within a treatment session and on follow-up visits. There is no research utilizing pain threshold perception as an objective outcome of these treatments. Only one study compared the two treatment techniques and concluded that future research should be completed which includes manual therapy for the thoracic spine. (Cleland 2007)

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2012

Geographic Reach
1 country

2 active sites

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

December 1, 2012

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

December 22, 2012

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 4, 2013

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

January 4, 2013

Status Verified

January 1, 2013

Enrollment Period

1 year

First QC Date

December 22, 2012

Last Update Submit

January 2, 2013

Conditions

Neck PainCervical Pain

Keywords

neck paincervical painpain pressure thresholdspain catastrophizing

Outcome Measures

Primary Outcomes (3)

  • Pain

    Verbal Descriptor on a scale from 0-10

    Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)

  • Neck Disability

    Neck Disability Index

    Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)

  • Pain Pressure Thresholds

    Using Wagner FDX Algometer

    Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)

Secondary Outcomes (4)

  • Pain Catastrophizing

    Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)

  • Global Rating of Change

    Baseline will be assessed at Week 1 and change from this measurement taken at Week 4

  • ROM

    Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks)

  • Clinical Equipoise

    Baseline

Study Arms (2)

Manual Manipulation

EXPERIMENTAL

Patients will be randomized to receive a thrust manipulation

Procedure: Manual Manipulation

Manual Mobilization

EXPERIMENTAL

Patients will be randomized to receive mobilization

Procedure: Mobilization

Interventions

Manual ManipulationPROCEDURE

A grade 5 thrust to the thoracic spine

Also known as: Thrust
Manual Manipulation
MobilizationPROCEDURE

A grade 1-4 mobilization directed at thoracic spine

Also known as: Springing
Manual Mobilization

Eligibility Criteria

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

You may qualify if:

  • Patients with non-traumatic Neck Pain
  • Between ages 18 - 60

You may not qualify if:

  • Red flags such as:
  • leg weakness
  • night pain
  • history of cancer
  • upper motor neuron signs
  • infection
  • tumors
  • osteoporosis
  • fracture
  • 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 (2)

Keystone Rehabilitation Systems

Bridgeville, Pennsylvania, 15017, United States

RECRUITING

Allegheny Chesapeake Physical Therapy

Pittsburgh, Pennsylvania, 15218, United States

RECRUITING

MeSH Terms

Conditions

Neck Pain

Interventions

Musculoskeletal ManipulationsHeimlich Maneuver

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationEmergency Treatment

Study Officials

  • Steve Karas, DSc

    Chatham University

    STUDY DIRECTOR

  • Joseph B Brence, DPT

    Keystone Rehabilitation Systems

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Steve Karas, DSc

CONTACT

412-365-2798skaras@chatham.edu

Joseph Brence, DPT

CONTACT

412-257-9660joseph.brence@physiocorp.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Co-Investigator

Study Record Dates

First Submitted

December 22, 2012

First Posted

January 4, 2013

Study Start

December 1, 2012

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

January 4, 2013

Record last verified: 2013-01

Locations

US(2)