Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain
Primary Purpose
Neck Pain
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain Neuroscience Education
Progressive submaximal exercise program
Sponsored by
About this trial
This is an interventional treatment trial for Neck Pain focused on measuring Neck pain, Telerehabilitation, Pain neuroscience education
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Sites / Locations
- School of Physical Therapy and Rehabilitation, Dokuz Eylül University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Pain Neuroscience Education (PNE)
Exercise + PNE
Arm Description
Telerehabilitation based pain neuroscience education
Telerehabilitation based progressive submaximal exercise program and PNE
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Neck Disability Index
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The ındex consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicate having more disabilities.
Tampa Scale of Kinesiophobia
Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia, which is an anxiety state that develops against activity and physical movement due to pain and fear of re-injury. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement.
Pain Catastrophising Scale
Pain Catastrophising Scale will be used to determine the degree of pain catastrophising felt by individuals with pain. Pain Catastrophising Scale is a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
The Turkish version of the World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF) will be used to assess the quality of life. The scale consists of 4 quality of life domains: physical, psychological, social relations and environmental. It has 27 statements and the maximum score is 135. Higher score means higher quality of life.
Full Information
NCT ID
NCT05249517
First Posted
January 12, 2022
Last Updated
February 14, 2023
Sponsor
Dokuz Eylul University
1. Study Identification
Unique Protocol Identification Number
NCT05249517
Brief Title
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain
Official Title
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
February 1, 2022 (Actual)
Primary Completion Date
September 8, 2022 (Actual)
Study Completion Date
December 8, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dokuz Eylul University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as "continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. 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. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain.
While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature.
This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life.
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. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Neck pain, Telerehabilitation, Pain neuroscience education
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Pain Neuroscience Education (PNE)
Arm Type
Experimental
Arm Description
Telerehabilitation based pain neuroscience education
Arm Title
Exercise + PNE
Arm Type
Active Comparator
Arm Description
Telerehabilitation based progressive submaximal exercise program and PNE
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Progressive submaximal exercise program
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numeric Pain Rating Scale
Description
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.
Time Frame
6 weeks
Title
Neurophysiology of Pain Questionnaire
Description
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.
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Neck Disability Index
Description
The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The ındex consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicate having more disabilities.
Time Frame
6 weeks
Title
Tampa Scale of Kinesiophobia
Description
Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia, which is an anxiety state that develops against activity and physical movement due to pain and fear of re-injury. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement.
Time Frame
6 weeks
Title
Pain Catastrophising Scale
Description
Pain Catastrophising Scale will be used to determine the degree of pain catastrophising felt by individuals with pain. Pain Catastrophising Scale is a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.
Time Frame
6 weeks
Title
World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Description
The Turkish version of the World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF) will be used to assess the quality of life. The scale consists of 4 quality of life domains: physical, psychological, social relations and environmental. It has 27 statements and the maximum score is 135. Higher score means higher quality of life.
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yesim SALIK SENGUL, Assoc. Prof.
Organizational Affiliation
Dokuz Eylul University
Official's Role
Principal Investigator
Facility Information:
Facility Name
School of Physical Therapy and Rehabilitation, Dokuz Eylül University
City
İzmir
Country
Turkey
12. IPD Sharing Statement
Learn more about this trial
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain
We'll reach out to this number within 24 hrs