- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05249517
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain
Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ahmet Öztürk, BSc
- Phone Number: +902324888341
- Email: ahmetozturk43@gmail.com
Study Locations
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İzmir, Turkey
- School of Physical Therapy and Rehabilitation, Dokuz Eylül University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Pain Neuroscience Education (PNE)
Telerehabilitation based pain neuroscience education
|
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.
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Active Comparator: Exercise + PNE
Telerehabilitation based progressive submaximal exercise program and PNE
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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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Numeric Pain Rating Scale
Time Frame: 6 weeks
|
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.
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6 weeks
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Neurophysiology of Pain Questionnaire
Time Frame: 6 weeks
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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.
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6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Neck Disability Index
Time Frame: 6 weeks
|
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.
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6 weeks
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Tampa Scale of Kinesiophobia
Time Frame: 6 weeks
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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.
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6 weeks
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Pain Catastrophising Scale
Time Frame: 6 weeks
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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.
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6 weeks
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World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)
Time Frame: 6 weeks
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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.
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6 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DokuzEU_AO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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