GPR vs Manual PT for Chronic Neck Pain

Nonspecific Chronic Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01947231
• Other study ID #: 2436/2013
• Status: Completed
• Phase: N/A
• First received: September 3, 2013
• Last updated: January 29, 2017
• Start date: September 2013
• Est. completion date: November 2014

Study information

• Verified date: January 2017
• Source: University of Bologna
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Neck Pain
• Nonspecific Chronic Neck Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Italy	Policlinico S. Orsola-Malpighi	Bologna	Emiglia-Romagna

Sponsors (1)

Lead Sponsor	Collaborator
University of Bologna

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain	The investigators assessed this outcome with a Visual Analogue Scale (VAS).	9 weeks after start of intervention
Primary	Cervical Functional Limitations	The investigators assessed this outcome with the Neck Disability Index.	9 weeks after start of intervention
Secondary	Kinesiophobia	The investigators assessed this outcome with the Tampa Scale of Kinesiophobia.	9 weeks after start of intervention
Secondary	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
Secondary	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
Secondary	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