GPR vs Manual PT for Chronic Neck Pain

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by University of Bologna
Sponsor:
Information provided by (Responsible Party):
paolo pillastrini, University of Bologna
ClinicalTrials.gov Identifier:
NCT01947231
First received: September 3, 2013
Last updated: September 20, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Nonspecific Chronic Neck Pain
Other: Global Postural Re-education
Other: Standard manual physical therapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over

Resource links provided by NLM:


Further study details as provided by University of Bologna:

Primary Outcome Measures:
  • Pain [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    The investigators assessed this outcome with a Visual Analogue Scale (VAS).

  • Cervical Functional Limitations [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    The investigators assessed this outcome with the Neck Disability Index.


Secondary Outcome Measures:
  • Kinesiophobia [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.

  • Cervical Range of Motion [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    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 [ Time Frame: 9 weeks after start of intervention ] [ Designated as safety issue: No ]
    The investigators assessed this outcome with the Physical Therapy Patient Satisfaction Questionnaire - Italian Version which has established psychometric properties.


Estimated Enrollment: 100
Study Start Date: July 2013
Estimated Study Completion Date: July 2015
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Global Postural Re-education
Global Postural Re-education is delivered in a single treatment session each week for nine weeks.
Other: Global Postural Re-education
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.
Active Comparator: Standard manual physical therapy
Standard manual physical therapy is delivered in a single treatment session each week for 9 weeks.
Other: Standard manual physical therapy
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01947231

Locations
Italy
Policlinico S. Orsola-Malpighi Recruiting
Bologna, Emiglia-Romagna, Italy, 40138
Contact: Paolo Pillastrini       ppillastrini@unibo.it   
Principal Investigator: Paolo Pillastrini         
Sponsors and Collaborators
University of Bologna
Investigators
Principal Investigator: Paolo Pillastrini University of Bologna
  More Information

No publications provided

Responsible Party: paolo pillastrini, Associate Professor and President of Baccaluareate Course in Physiotherapy, University of Bologna
ClinicalTrials.gov Identifier: NCT01947231     History of Changes
Other Study ID Numbers: 2436/2013
Study First Received: September 3, 2013
Last Updated: September 20, 2013
Health Authority: Italy: Ethics Committee

Keywords provided by University of Bologna:
neck pain
chronic
Global Postural Re-education
manual therapy
physical therapy

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

ClinicalTrials.gov processed this record on August 20, 2014