NCT05249517

Brief Summary

In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2022

Shorter than P25 for not_applicable

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

First Submitted

Initial submission to the registry

January 12, 2022

Completed
20 days until next milestone

Study Start

First participant enrolled

February 1, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

February 21, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 8, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 8, 2022

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

7 months

First QC Date

January 12, 2022

Last Update Submit

February 14, 2023

Conditions

Neck Pain

Keywords

Neck painTelerehabilitationPain neuroscience education

Outcome Measures

Primary Outcomes (2)

  • Numeric Pain Rating Scale

    Numerical Pain Rating Scale will be used to evaluate the severity of pain. Participants will be asked to determine the number that best describes their pain, with 0 = no pain and 10 = unbearable pain, on a scale divided into numbers between 0 and 10 for the severity of pain they feel during rest and activity.

    6 weeks

  • Neurophysiology of Pain Questionnaire

    The Neurophysiology of Pain Questionnaire will be used to assess pain information. The Pain Neurophysiology Questionnaire was developed as a method of assessing whether healthcare professionals and patients understand the pain and its underlying complex neurophysiological mechanisms. Scoring is in the range of 0-13 points according to the number of correct answers given. Higher scores mean better pain knowledge. It is widely used by clinicians to monitor information exchange in pain education interventions.

    6 weeks

Secondary Outcomes (4)

  • Neck Disability Index

    6 weeks

  • Tampa Scale of Kinesiophobia

    6 weeks

  • Pain Catastrophising Scale

    6 weeks

  • World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)

    6 weeks

Study Arms (2)

Pain Neuroscience Education (PNE)

EXPERIMENTAL

Telerehabilitation based pain neuroscience education

Other: Pain Neuroscience Education

Exercise + PNE

ACTIVE COMPARATOR

Telerehabilitation based progressive submaximal exercise program and PNE

Other: Progressive submaximal exercise program

Interventions

Pain Neuroscience EducationOTHER

Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain.

Pain Neuroscience Education (PNE)
Progressive submaximal exercise programOTHER

It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood.

Exercise + PNE

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Being between the ages of 18-55
  • History of neck pain lasting at least three months
  • Agreeing to participate in the study
  • Being able to read and write Turkish
  • Having a computer or tablet and an active internet connection at home
  • To be able to use a computer, tablet and internet at a level to participate in video conference or to have a relative who can help in this regard.

You may not qualify if:

  • History of spinal surgery
  • Traumatic cervical injuries
  • Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
  • Tumor conditions
  • Having vision and hearing problems
  • Cognitive problems
  • Receiving physiotherapy for neck and/or low back pain in the last 6 months

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Physical Therapy and Rehabilitation, Dokuz Eylül University

Izmir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Yesim SALIK SENGUL, Assoc. Prof.

    Dokuz Eylul University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Parallel Assignment
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 12, 2022

First Posted

February 21, 2022

Study Start

February 1, 2022

Primary Completion

September 8, 2022

Study Completion

December 8, 2022

Last Updated

February 15, 2023

Record last verified: 2023-02

Locations

TU(1)