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The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain

This study is currently recruiting participants.
Verified January 2013 by Keystone Rehabilitation Systems
Sponsor:
Information provided by (Responsible Party):
Joseph Brence, Keystone Rehabilitation Systems
ClinicalTrials.gov Identifier:
NCT01760590
First received: December 22, 2012
Last updated: January 2, 2013
Last verified: January 2013
History of Changes
  Purpose

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)


Condition Intervention
Neck Pain
Cervical Pain
 Procedure: Manual Manipulation
Procedure: Mobilization

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effects of Thoracic Spine Manipulation and Mobilization in Individuals With Nontraumatic Cervical Pain

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Keystone Rehabilitation Systems:

Primary Outcome Measures:
  • Pain [ Time Frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks) ] [ Designated as safety issue: No ]
    Verbal Descriptor on a scale from 0-10

  • Neck Disability [ Time Frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks) ] [ Designated as safety issue: No ]
    Neck Disability Index

  • Pain Pressure Thresholds [ Time Frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks) ] [ Designated as safety issue: No ]
    Using Wagner FDX Algometer


Secondary Outcome Measures:
  • Pain Catastrophizing [ Time Frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks) ] [ Designated as safety issue: No ]
    Pain Catastrophizing Scale

  • Global Rating of Change [ Time Frame: Baseline will be assessed at Week 1 and change from this measurement taken at Week 4 ] [ Designated as safety issue: No ]
    % of perceived change following intervention

  • ROM [ Time Frame: Baseline, change from baseline to week 1 and change from baseline to week 4 (discharge as per PTs discretion but typically 4 weeks) ] [ Designated as safety issue: No ]
    Bubble goniometry of cervical motion

  • Clinical Equipoise [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    This will measure examiners C.E


Estimated Enrollment: 100
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Manual Manipulation
Patients will be randomized to receive a thrust manipulation
 Procedure: Manual Manipulation
A grade 5 thrust to the thoracic spine
Other Name: Thrust
Experimental: Manual Mobilization
Patients will be randomized to receive mobilization
 Procedure: Mobilization
A grade 1-4 mobilization directed at thoracic spine
Other Name: Springing

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA:

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

EXCLUSION CRITERIA:

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01760590

Contacts
Contact: Steve Karas, DSc 412-365-2798 skaras@chatham.edu
Contact: Joseph Brence, DPT 412-257-9660 joseph.brence@physiocorp.com

Locations
United States, Pennsylvania
Keystone Rehabilitation Systems Recruiting
Bridgeville, Pennsylvania, United States, 15017
Contact: Joseph Brence, DPT     412-257-9660        
Principal Investigator: Joseph B Brence, DPT            
Allegheny Chesapeake Physical Therapy Recruiting
Pittsburgh, Pennsylvania, United States, 15218
Contact: Dave Thompson, DPT     412-244-7750        
Principal Investigator: Dave Thompson, DPT            
Sponsors and Collaborators
Keystone Rehabilitation Systems
Investigators
Study Director: Steve Karas, DSc Chatham University
Principal Investigator: Joseph B Brence, DPT Keystone Rehabilitation Systems
  More Information

No publications provided

Responsible Party: Joseph Brence, Co-Investigator, Keystone Rehabilitation Systems
ClinicalTrials.gov Identifier: NCT01760590     History of Changes
Other Study ID Numbers: KRS2
Study First Received: December 22, 2012
Last Updated: January 2, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Keystone Rehabilitation Systems:
neck pain
cervical pain
pain pressure thresholds
pain catastrophizing

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on May 19, 2013