NCT02904668

Brief Summary

Neck pain is a complex biopsychosocial disorder often precipitated or aggravated by neck movements or sustained neck postures. The onset and course of this pain is influenced by environmental and personal factors.Many studies report that participants preferred self-care measures for the management of neck pain and they sought professional help only when those measures fail.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
53

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2016

Shorter than P25 for not_applicable

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, 2016

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

September 2, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 19, 2016

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

October 10, 2018

Status Verified

October 1, 2018

Enrollment Period

1 month

First QC Date

September 2, 2016

Last Update Submit

October 8, 2018

Conditions

Keywords

chronic pain

Outcome Measures

Primary Outcomes (1)

  • Disability

    Disability will be explored using the Neck Disability Index. The patients rated their current pain and average pain over the past week on a 0-10 numerical rating scale

    Change from baseline pain at 3 weeks

Secondary Outcomes (4)

  • Pain severity

    Change from baseline pain at 3 weeks

  • Health related quality of life

    Change from baseline health related quality of life at 4 weeks

  • Fear avoidance beliefs

    Change from baseline fear avoidance beliefs at 4 weeks

  • Anxiety and depression

    Change from baseline anxiety and depression at 4 weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Patients allocated to the experimental group were included in a self-management program and manual therapy program

Other: self-managmeent program

Control group

ACTIVE COMPARATOR

The intervention consisted of 45-minute manual therapy sessions. Manual therapy included "hands-on" muscular mobilization techniques (aimed at improving soft tissue function), specific articular mobilization techniques (to improve overall joint function and decrease any restrictions in movement at single or multiple segmental levels in the cervical spine), and coordination or stabilization techniques (to improve postural control, coordination, and movement patterns by using the stabilizing cervical musculature)

Other: self-managmeent program

Interventions

One session was a session supervised by a physical therapist in the Faculty of Health Sciences. The program contents were educative information about chronic neck pain and healthy lifestyle habits (application of local heat/cold, and sleeping face down, using correct sitting posture, alternating body position, and using correct lifting technique (…), which were complemented by a problem-based session.

Control groupExperimental group

Eligibility Criteria

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

You may qualify if:

  • Chronic neck pain (at least 6 months' duration) not related to trauma .

You may not qualify if:

  • Whiplash related neck pain
  • Previous cervical surgical intervention
  • Cognitive impairments which prevent them to follow instructions
  • Visual or acoustic limitations
  • Physical therapy in the previous six months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck PainChronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

September 2, 2016

First Posted

September 19, 2016

Study Start

September 1, 2016

Primary Completion

October 1, 2016

Study Completion

December 1, 2016

Last Updated

October 10, 2018

Record last verified: 2018-10