GPR vs Manual PT for Chronic Neck Pain

Randomized Controlled Trial of Global Postural Re-education vs. Standard Manual Physical Therapy for Non-specific Chronic Neck Pain With Cross-over

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.

Study Overview

• Status: Completed
• Conditions: Nonspecific Chronic Neck Pain
• Intervention / Treatment: Other: Global Postural Re-education; Other: Standard manual physical therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Emiglia-Romagna
    • Bologna, Emiglia-Romagna, Italy, 40138
      • Policlinico S. Orsola-Malpighi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years to 76 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain	The investigators assessed this outcome with a Visual Analogue Scale (VAS).	9 weeks after start of intervention
Cervical Functional Limitations	The investigators assessed this outcome with the Neck Disability Index.	9 weeks after start of intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Kinesiophobia	The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.	9 weeks after start of intervention
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.	9 weeks after start of intervention
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.	9 weeks after start of intervention
Patient Satisfaction	The investigators assessed this outcome with the Physical Therapy Patient Satisfaction Questionnaire - Italian Version which has established psychometric properties.	9 weeks after start of intervention

Collaborators and Investigators

• Sponsor: University of Bologna
• Investigators: Principal Investigator: Paolo Pillastrini, University of Bologna

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2013
• Primary Completion (Actual): November 1, 2014
• Study Completion (Actual): November 1, 2014

Study Registration Dates

• First Submitted: September 3, 2013
• First Submitted That Met QC Criteria: September 17, 2013
• First Posted (Estimate): September 20, 2013

Study Record Updates

• Last Update Posted (Estimate): January 31, 2017
• Last Update Submitted That Met QC Criteria: January 29, 2017
• Last Verified: January 1, 2017

More Information

Terms related to this study

• Keywords: neck pain; manual therapy; chronic; physical therapy; Global Postural Re-education
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 2436/2013