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Clinical Trials/NCT01760590
NCT01760590UnknownNot Applicable

The Effects of Thoracic Spine Manipulation and Mobilization in Individuals With Nontraumatic Cervical Pain

Keystone Rehabilitation Systems4 sites in 1 country100 target enrollmentStarted: December 1, 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Sponsor
Enrollment
100
Locations
4
Primary Endpoint
Pain

Study Overview

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)

Detailed Description

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)

The subjects will be patients at clinics owned by Physiotherapy Associates, Fit Physical Therapy, and Allegheny and Chesapeake PT who seek physical therapy services for nontraumatic neck pain. Participation will be entirely voluntary.

Patients will be offered a chance to participate in the research project on their initial visit for Physical Therapy.

If the PT identifies an appropriate patient they will ask if they are interested in being a research subject. The Physical Therapist recruiting subjects all have completed their Doctor of Physical Therapy Degree and have advanced training in manual Physical Therapy. The techniques employed are considered standard practice and are defined as entry level skills by the Commission of Accredidation of Physical Therapy Programs. These techniques are typically taught in DPT degree programs.

If the patient is interested, a description of the study will be provided. A consent form will be given to all participants.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • osteoporosis
  • history of whiplash within 6 weeks
  • cervical stenosis
  • CNS involvement
  • signs consistent with nerve root compression
  • previous surgery
  • pending legal action

Outcomes

Primary Outcomes

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)

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)

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)

Using Wagner FDX Algometer

Secondary Outcomes

  • 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)

Investigators

Sponsor
Keystone Rehabilitation Systems
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Joseph Brence

Co-Investigator

Keystone Rehabilitation Systems

Study Sites (4)

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