NCT03362333

Brief Summary

This study examined the effects of pain neuroscience education plus exercise when compared with exercise only in university students with chronic idiopathic neck pain.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Oct 2015

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2016

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

November 28, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 5, 2017

Completed
Last Updated

December 5, 2017

Status Verified

December 1, 2017

Enrollment Period

5 months

First QC Date

November 28, 2017

Last Update Submit

December 4, 2017

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity

    Measured using the visual analogue scale

    At the beginning

  • Pain intensity

    Measured using the visual analogue scale

    5 weeks

  • Pain intensity

    Measured using the visual analogue scale

    At 3 months

Secondary Outcomes (20)

  • Deep neck flexor endurance

    At the beginning

  • Deep neck flexor endurance

    5 weeks

  • Neck extensors endurance

    At the beginning

  • Neck extensors endurance

    5 weeks

  • Scapular stabilizers endurance

    At the beginning

  • +15 more secondary outcomes

Study Arms (2)

pain neuroscience education and exercise

EXPERIMENTAL

This group received pain neuroscience education and exercise once a week over 4 weeks

Other: ExerciseOther: Pain neuroscience education

Exercise

ACTIVE COMPARATOR

This group received exercise directed at the neck and shoulder regions once a week over 4 weeks

Other: Exercise

Interventions

Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular stabilizer muscles.

Exercisepain neuroscience education and exercise

Pain neuroscience education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience.

pain neuroscience education and exercise

Eligibility Criteria

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

You may qualify if:

  • Participants could enter the study if they had chronic idiopathic neck pain, defined as pain felt in the neck at least once a week in the previous 3 months and for which no cause had been established. Furthermore, they were required to have a minimum pain intensity in the previous week of 2 in the visual analogue scale.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Neck Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Anabela Silva, PhD

    University of Aveiro

    PRINCIPAL INVESTIGATOR

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
Dr

Study Record Dates

First Submitted

November 28, 2017

First Posted

December 5, 2017

Study Start

October 1, 2015

Primary Completion

February 28, 2016

Study Completion

October 30, 2016

Last Updated

December 5, 2017

Record last verified: 2017-12

Data Sharing

IPD Sharing
Will not share