NCT02827994

Brief Summary

This study compared the effectiveness of pain neurophysiology education and neck/shoulder exercises with no intervention in adolescents with chronic idiopathic neck pain (CINP).

Trial Health

100
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

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

March 1, 2015

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2016

Completed
18 days until next milestone

First Posted

Study publicly available on registry

July 11, 2016

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

3 months

First QC Date

June 23, 2016

Last Update Submit

July 6, 2016

Conditions

Outcome Measures

Primary Outcomes (2)

  • Pain intensity

    Method of assessment - Visual analogue scale

    At the beginning

  • Pain intensity

    Method of assessment - Visual analogue scale

    5 weeks

Secondary Outcomes (19)

  • Neck pain frequency

    At the beginning

  • Neck pain frequency

    5 weeks

  • Neck pain duration

    At the beginning

  • Neck pain duration

    5 weeks

  • Neck pain associated disability

    At the beginning

  • +14 more secondary outcomes

Study Arms (2)

Education and exercise

EXPERIMENTAL

The intervention included neurophysiology of pain education and exercises.

Other: neurophysiology of pain education and exercises

No intervention

NO INTERVENTION

This group received no intervention as participants were students that were not seeking treatment for their pain.

Interventions

Pain neurophysiology education covered the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. It was delivered in small groups (4 to 7 participants). A total of 4 sessions were delivered over 4 weeks (1 session per week). Each session took between 45 minutes and 1 hour. Exercises were aimed at increasing the endurance and strength of the deep neck flexor and extensor muscles and of the scapular muscles delivered over 3 sessions (the first session covered pain neurophysiology education only). Each exercise was performed in 3 series of 10 repetitions. The number of exercises targeting the same group of muscles increased from one in the 2nd session to 2/3 in the 4th session.

Education and exercise

Eligibility Criteria

Age16 Years - 20 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • To be invited to enter the study participants had to have chronic idiopathic neck/shoulder pain, defined as pain felt in the neck/shoulder regions at least once a week in the previous 3 months.

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 Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 23, 2016

First Posted

July 11, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2015

Study Completion

June 1, 2015

Last Updated

July 11, 2016

Record last verified: 2016-07

Data Sharing

IPD Sharing
Will not share