NCT01947231

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

September 3, 2013

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 20, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2014

Completed
Last Updated

January 31, 2017

Status Verified

January 1, 2017

Enrollment Period

1.2 years

First QC Date

September 3, 2013

Last Update Submit

January 29, 2017

Conditions

Nonspecific Chronic Neck Pain

Keywords

neck painchronicGlobal Postural Re-educationmanual therapyphysical therapy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (4)

  • Kinesiophobia

    9 weeks after start of intervention

  • Cervical Range of Motion

    9 weeks after start of intervention

  • Self-reported Global Effect of the Intervention

    9 weeks after start of intervention

  • Patient Satisfaction

    9 weeks after start of intervention

Study Arms (2)

Global Postural Re-education

EXPERIMENTAL

Global Postural Re-education is delivered in a single treatment session each week for nine weeks.

Other: Global Postural Re-education

Standard manual physical therapy

ACTIVE COMPARATOR

Standard manual physical therapy is delivered in a single treatment session each week for 9 weeks.

Other: Standard manual physical therapy

Interventions

Global Postural Re-educationOTHER

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.

Global Postural Re-education
Standard manual physical therapyOTHER

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.

Standard manual physical therapy

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • nonspecific neck pain lasting at least 3 months

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Policlinico S. Orsola-Malpighi

Bologna, Emiglia-Romagna, 40138, Italy

Location

MeSH Terms

Conditions

Neck PainBronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsOrganizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

  • Paolo Pillastrini

    University of Bologna

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor and President of Baccaluareate Course in Physiotherapy

Study Record Dates

First Submitted

September 3, 2013

First Posted

September 20, 2013

Study Start

September 1, 2013

Primary Completion

November 1, 2014

Study Completion

November 1, 2014

Last Updated

January 31, 2017

Record last verified: 2017-01

Locations

IT(1)