The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain
Primary Purpose
Neck Pain, Cervical Pain
Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Manual Manipulation
Mobilization
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring neck pain, cervical pain, pain pressure thresholds, pain catastrophizing
Eligibility 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
Sites / Locations
- Keystone Rehabilitation SystemsRecruiting
- Allegheny Chesapeake Physical TherapyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Manual Manipulation
Manual Mobilization
Arm Description
Patients will be randomized to receive a thrust manipulation
Patients will be randomized to receive mobilization
Outcomes
Primary Outcome Measures
Pain
Verbal Descriptor on a scale from 0-10
Neck Disability
Neck Disability Index
Pain Pressure Thresholds
Using Wagner FDX Algometer
Secondary Outcome Measures
Pain Catastrophizing
Pain Catastrophizing Scale
Global Rating of Change
% of perceived change following intervention
ROM
Bubble goniometry of cervical motion
Clinical Equipoise
This will measure examiners C.E
Full Information
NCT ID
NCT01760590
First Posted
December 22, 2012
Last Updated
January 2, 2013
Sponsor
Keystone Rehabilitation Systems
1. Study Identification
Unique Protocol Identification Number
NCT01760590
Brief Title
The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain
Official Title
The Effects of Thoracic Spine Manipulation and Mobilization in Individuals With Nontraumatic Cervical Pain
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Unknown status
Study Start Date
December 2012 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
December 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keystone Rehabilitation Systems
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
Research Procedures:
Patients who present to one of three Physical Therapy clinics, under the direction of three advanced clinicians, will be assessed for their potential participation in this research. The treating clinician will recruit appropriate subjects based on includion and exclusion criteria and their PT diagnosis. Those that meet the inclusion and exclusion criteria will be given the consent form to determine if they wish to participate. Each researcher will have formal training in these techniques. Two of the clinicians have received their Orthopedic Clinical Specialists certification under the examination prcess outlined by the American Physical Therapy association. A third researcher has obtained his fellowship designation from the American Academy of Orthopedic Manual Physical Therapy. This skill is deemed entry level by the the Accredidation Board of the American Physical Therapy Educators. All Therapists will undergo a prestudy hands on education program to ensure the use of similar techniques.
If after reading the consent form they agree to participate, they will be given one additional form, the Pain Catastrophizing scale, and asked to complete it. The scale, NDI, cervical ROM, age, and birthdate will be recorded on a sheet contained in the patient's clinical chart.
The PT evaluation will then be completed.
They will then be randomized into one of two groups based on a roll of a die:
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 5 mobilization group: this group wil receive a grade 5 mobilization.
Additional treatment including patient eduation, modalities, and exercise will be completed as the PT deems appropriate,
The second visit will be scheduled within 24 to 48 hours.
The patient will complete the same forms as were completed during the initial evaluation (NDI, PCS) and return them so that the results may berecorded on the record sheet identified only with date of birth.
The treatment will be repeated including the manual technique and other treatment deemed appropriate by the PT. Additional treatment between the second and last visits will be under the sole discretion on the treating PT.
On the discharge visit, the patient will receive the same forms, and be asked how much, in terms of %, they feel they have improved. This information will be recorded on the deidentified sheet.
Home exercise programs and patient educaiton will be issued as appropriate.
A bubble goniometer will be used for range of motion assessment. This is a standard plastic device used in PT practice. A Wagner FDX digital force gauge algometer will measure pain pressure thresholds.
Where survey instruments are involved, a copy of the instrument and, for surveys not created for this project, assurance that the principal investigator has proper approval to use them.
The Neck Disability Index or NDI will be used. It is the professional standard for outcomes measures for people with neck pain.
It has been shown to be valid and reliable.
The Pain Castrophizing Scale will be used. It is a valid and reliable measure of a patient's perception of pain and is commonly used.
The data will be collected by the treating Physical Therapist who has access to the patient record for treatment purposes.
The data will not be used for purposes other that patient care and research purposes.
Patient's data measures will be collected on a de-identified sheet marked with the patients birthday. The will be kept in a locked area in the clinic. The lead investigator will have access to the data when the study is completed and transfer it to a locked file cabinet in his office for data assessment.
Following treatment the patient may have mild soreness over the area which was treated. This typically diminishes in 24 hours. the patient will be informed of this potential soreness. The use of heat and /or ice, exercise, and patient education provided by the Therapist concerning activities and posture will also lessen the soreness.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Cervical Pain
Keywords
neck pain, cervical pain, pain pressure thresholds, pain catastrophizing
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Manual Manipulation
Arm Type
Experimental
Arm Description
Patients will be randomized to receive a thrust manipulation
Arm Title
Manual Mobilization
Arm Type
Experimental
Arm Description
Patients will be randomized to receive mobilization
Intervention Type
Procedure
Intervention Name(s)
Manual Manipulation
Other Intervention Name(s)
Thrust
Intervention Description
A grade 5 thrust to the thoracic spine
Intervention Type
Procedure
Intervention Name(s)
Mobilization
Other Intervention Name(s)
Springing
Intervention Description
A grade 1-4 mobilization directed at thoracic spine
Primary Outcome Measure Information:
Title
Pain
Description
Verbal Descriptor on a scale from 0-10
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)
Title
Neck Disability
Description
Neck Disability Index
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)
Title
Pain Pressure Thresholds
Description
Using Wagner FDX Algometer
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)
Secondary Outcome Measure Information:
Title
Pain Catastrophizing
Description
Pain Catastrophizing Scale
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)
Title
Global Rating of Change
Description
% of perceived change following intervention
Time Frame
Baseline will be assessed at Week 1 and change from this measurement taken at Week 4
Title
ROM
Description
Bubble goniometry of cervical motion
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)
Title
Clinical Equipoise
Description
This will measure examiners C.E
Time Frame
Baseline
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Steve Karas, DSc
Phone
412-365-2798
Email
skaras@chatham.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Joseph Brence, DPT
Phone
412-257-9660
Email
joseph.brence@physiocorp.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steve Karas, DSc
Organizational Affiliation
Chatham University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Joseph B Brence, DPT
Organizational Affiliation
Keystone Rehabilitation Systems
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keystone Rehabilitation Systems
City
Bridgeville
State/Province
Pennsylvania
ZIP/Postal Code
15017
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph Brence, DPT
Phone
412-257-9660
First Name & Middle Initial & Last Name & Degree
Joseph B Brence, DPT
Facility Name
Allegheny Chesapeake Physical Therapy
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15218
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dave Thompson, DPT
Phone
412-244-7750
First Name & Middle Initial & Last Name & Degree
Dave Thompson, DPT
12. IPD Sharing Statement
Learn more about this trial
The Effects of Thoracic Spine Manipulation in Individuals With Non-traumatic Cervical Pain
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