GPR vs Manual PT for Chronic Neck Pain
Primary Purpose
Nonspecific Chronic Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Global Postural Re-education
Standard manual physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Nonspecific Chronic Neck Pain focused on measuring neck pain, chronic, Global Postural Re-education, manual therapy, physical therapy
Eligibility Criteria
Inclusion Criteria:
-nonspecific neck pain lasting at least 3 months
Exclusion Criteria:
- acute or subacute cervical pain
- specific or known cause of pain
- central or peripheral neurological signs
- systemic pathology
- rheumatologic pathology
- neuromuscular pathology
- cognitive impairment
- surgical intervention in the last 6 months prior to study
- physical therapy treatment in the last 6 months prior to study
Sites / Locations
- Policlinico S. Orsola-Malpighi
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Global Postural Re-education
Standard manual physical therapy
Arm Description
Global Postural Re-education is delivered in a single treatment session each week for nine weeks.
Standard manual physical therapy is delivered in a single treatment session each week for 9 weeks.
Outcomes
Primary Outcome Measures
Pain
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Cervical Functional Limitations
The investigators assessed this outcome with the Neck Disability Index.
Secondary Outcome Measures
Kinesiophobia
The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.
Cervical Range of Motion
The investigators assessed this outcome with the CROM-Deluxe which is an inclinometer that is placed on the subject's head to measure cervical range of motion.
Self-reported Global Effect of the Intervention
The investigators assessed this outcome with a Global Perceived Effect scale which measures the subject's self-reported improvement or deterioration following the intervention.
Patient Satisfaction
The investigators assessed this outcome with the Physical Therapy Patient Satisfaction Questionnaire - Italian Version which has established psychometric properties.
Full Information
NCT ID
NCT01947231
First Posted
September 3, 2013
Last Updated
January 29, 2017
Sponsor
University of Bologna
1. Study Identification
Unique Protocol Identification Number
NCT01947231
Brief Title
GPR vs Manual PT for Chronic Neck Pain
Official Title
Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
November 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bologna
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Effective treatment for nonspecific chronic neck pain is a clinical challenge. Patients will be randomized into two groups to compare the outcomes of Global Postural Re-education (GPR) with standard manual physical therapy on with respect to pain, function, kinesiophobia, range of motion, perceived effect, and satisfaction.
Detailed Description
These study will use two groups: one to receive GPR which is a systematic method of addressing musculoskeletal pain and related functional deficits and the other to receive "usual care" manual PT which will be individualized to the patient's condition. Usual care will include techniques commonly used in clinical practice selected by the physical therapist after initial examination. After nine weeks of treatment, baseline measures will be re-evaluated. After conclusion of the first phase of the study, patients who were randomized to the "usual care" group will cross-over and receive GPR.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nonspecific Chronic Neck Pain
Keywords
neck pain, chronic, Global Postural Re-education, manual therapy, physical therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Global Postural Re-education
Arm Type
Experimental
Arm Description
Global Postural Re-education is delivered in a single treatment session each week for nine weeks.
Arm Title
Standard manual physical therapy
Arm Type
Active Comparator
Arm Description
Standard manual physical therapy is delivered in a single treatment session each week for 9 weeks.
Intervention Type
Other
Intervention Name(s)
Global Postural Re-education
Intervention Description
Global Postural Re-education is a physical therapy method comprising a series of gentle active movements, implemented by the therapist using manual contacts and verbal commands, to promote postural symmetry.
Intervention Type
Other
Intervention Name(s)
Standard manual physical therapy
Intervention Description
Standard manual physical therapy in this study involves a combination of exercises, pompage (gentle manual techniques of distraction and articulation of a joint), anterior-posterior mobilizations as described by Maitland, and massage that have been selected to meet the needs of each individual patient.
Primary Outcome Measure Information:
Title
Pain
Description
The investigators assessed this outcome with a Visual Analogue Scale (VAS).
Time Frame
9 weeks after start of intervention
Title
Cervical Functional Limitations
Description
The investigators assessed this outcome with the Neck Disability Index.
Time Frame
9 weeks after start of intervention
Secondary Outcome Measure Information:
Title
Kinesiophobia
Description
The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.
Time Frame
9 weeks after start of intervention
Title
Cervical Range of Motion
Description
The investigators assessed this outcome with the CROM-Deluxe which is an inclinometer that is placed on the subject's head to measure cervical range of motion.
Time Frame
9 weeks after start of intervention
Title
Self-reported Global Effect of the Intervention
Description
The investigators assessed this outcome with a Global Perceived Effect scale which measures the subject's self-reported improvement or deterioration following the intervention.
Time Frame
9 weeks after start of intervention
Title
Patient Satisfaction
Description
The investigators assessed this outcome with the Physical Therapy Patient Satisfaction Questionnaire - Italian Version which has established psychometric properties.
Time Frame
9 weeks after start of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
-nonspecific neck pain lasting at least 3 months
Exclusion Criteria:
acute or subacute cervical pain
specific or known cause of pain
central or peripheral neurological signs
systemic pathology
rheumatologic pathology
neuromuscular pathology
cognitive impairment
surgical intervention in the last 6 months prior to study
physical therapy treatment in the last 6 months prior to study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paolo Pillastrini
Organizational Affiliation
University of Bologna
Official's Role
Principal Investigator
Facility Information:
Facility Name
Policlinico S. Orsola-Malpighi
City
Bologna
State/Province
Emiglia-Romagna
ZIP/Postal Code
40138
Country
Italy
12. IPD Sharing Statement
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GPR vs Manual PT for Chronic Neck Pain
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