NCT03667209

Brief Summary

This study will compare the effectiveness of pain neuroscience education and neck/shoulder traditional exercises versus pain neuroscience education and neck/shoulder suspension training exercises for patients with chronic idiopathic neck pain (CINP).

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2018

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 10, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 12, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

May 9, 2019

Status Verified

October 1, 2018

Enrollment Period

1.8 years

First QC Date

September 10, 2018

Last Update Submit

May 8, 2019

Conditions

Outcome Measures

Primary Outcomes (6)

  • Pain intensity: VAS

    Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).

    Baseline

  • Pain intensity: VAS

    Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).

    7 weeks

  • Pain intensity: VAS

    Method of assessment - Visual analogue scale (VAS), which measures pain intensity from a minimum of 0 to a maximum of 10 (maximum pain intensity).

    6 months

  • Neck pain associated disability

    Method of assessment - the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).

    Baseline

  • Neck pain associated disability

    Method of assessment - the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).

    7 weeks

  • Neck pain associated disability

    Method of assessment - the Neck Disability Index, which is a disability index with 5 questions on neck pain associated disability that ranges from 0 (no disability) to 50 (complete disability).

    6 months

Secondary Outcomes (30)

  • Neck pain frequency

    Baseline

  • Neck pain frequency

    7 weeks

  • Neck pain frequency

    6 months

  • Neck pain location

    Baseline

  • Neck pain location

    7 weeks

  • +25 more secondary outcomes

Study Arms (2)

Traditional exercise and pain neuroscience education

EXPERIMENTAL

Will include exercises of the neck and scapular regions using traditional methods and pain neuroscience education

Other: Pain neuroscience education (PNE) and traditional exercise

Suspension exercise and pain neuroscience education

ACTIVE COMPARATOR

Will include suspension exercises of the neck and scapular regions using traditional methods and pain education.

Other: Pain neuroscience education (PNE) and suspension exercise

Interventions

PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise of the neck and scapular regions, including strength, motor control and stretching exercises. Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour.

Traditional exercise and pain neuroscience education

PNE will cover the neurophysiology of pain, transition from acute to chronic pain and the nervous system ability to modulate the pain experience. Exercise of the neck and scapular regions, including strength, motor control and stretching exercises. delivered in suspension. Initially (first 3 sessions) will be delivered individually and then (last 3 sessions)in small groups (4 participants). A total of 6 sessions will be delivered during 6 weeks. Each session will take around 1 hour.

Suspension exercise and pain neuroscience education

Eligibility Criteria

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

You may qualify if:

  • Clinical diagnosis of chronic idiopathic neck pain.

You may not qualify if:

  • Cervical radiculopathy
  • Neck fractures
  • Tumors
  • Rheumatological disorders
  • Any other serious cause of neck pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Escola Superior de Saúde

Aveiro, Portugal

RECRUITING

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Anabela Silva, PhD

CONTACT

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
Principal Investigator

Study Record Dates

First Submitted

September 10, 2018

First Posted

September 12, 2018

Study Start

November 1, 2018

Primary Completion

September 1, 2020

Study Completion

December 1, 2020

Last Updated

May 9, 2019

Record last verified: 2018-10

Data Sharing

IPD Sharing
Will not share

Locations