Facet Joint ArthrosisNCT04981132
Effectiveness of Pain and Exercise Training With Telerehabilitation on Lumbar Facet Joint Arthrosis
A study testing Pain Neuroscience education + Progressive therapeutic exercise training and Progressive therapeutic exercise training in people with Facet Joint Arthrosis and Low Back Pain, run by Okan University at 1 site in Turkey (Türkiye).
Trial summary
The study investigates the effects of pain and exercise training via telerehabilitation method on pain, pain beliefs, trunk mobility, functionality, and quality of life in individuals with low back pain caused by facet joint arthrosis. Forty - five individuals are planning to include in the study. Read more about this study
- Who is it for?
- Ages 40 to 64 years
- Conditions the study is for
- Facet Joint Arthrosis, Low Back Pain
- What is being tested?
- Pain Neuroscience education + Progressive therapeutic exercise training and Progressive therapeutic exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Oct 2021to 15 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- volunteering,
- being the ages of 40 to 64
- having a diagnosis of Grade 1 or 2 facet joint arthrosis according to Pathria classification
- having pain for at least 12 weeks, primarily due to facet joint arthrosis
- having a pain score between 3 and 8 according to the Numerical Pain Scale (NRS)
- not having received education about pain before,
- having computer and internet access
Who cannot join
- having a BMI of 30 and above
- to have had conservative treatment or surgery in the lumbar region in the last 6 months,
- having severe deformity in the lower extremity
- having red or orange (pregnancy, disc pathology, infection, fracture, cancer, stenosis, severe osteoporosis, schmorl nodule, cauda equina syndrome, etc.) signs defined for low back pain
- having a regular exercise habit,
- having a seronegative rheumatological disease,
- having general pain syndrome.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigation of the Effectiveness of Pain and Exercise Training With Telerehabilitation Method in Patients With Low Back Pain Caused by Lumbar Facet Joint Arthrosis
The study investigates the effects of pain and exercise training via telerehabilitation method on pain, pain beliefs, trunk mobility, functionality, and quality of life in individuals with low back pain caused by facet joint arthrosis. Forty - five individuals are planning to include in the study. Participants will be randomly assigned to one of the three groups: Group 1: Pain education + exercise training group, Group 2: Exercise training group, and Group 3: Control group. The same physiotherapist will make evaluations via an online conference system. Group 1 will have pain neuroscience education and progressive therapeutic exercise training in a session for six weeks, twice a week, and Group 2 will have progressive therapeutic exercise training in a session for six weeks, twice a week, for six weeks, in total twelve sessions. Group 3 participants will be taken to the waiting list. Clinical and demographic data of the 45 participants in the study will be taken pre and post interventions. The primary outcomes are; the Numeric Pain Rating Scale (NPRS) and the Oswestry Disability Index (ODI). Secondary outcomes are the Active Straight Leg Raise Test (A- SLR), The Pain Belief Questionnaire (PBQ), and the Short Form Quality of Life Form (SF-12). Statistical analysis will be run through the SPSS 20.0 package program.
Read the detailed description
'Pain Neuroscience Education (PNE) is one of the cognitive approaches among conservative treatments, and has been one of the most inquisitive approaches. The content of the education includes the physiology of pain, types of pain, the areas in which it is represented in the brain, its effect on body image, and psychosocial dimensions. Education aims to break the patient's misinformation and perception about pain and teach how to manage pain. It aims to inform patients about the neurophysiological and neurobiological processes related to the pain experience and help change their misinformation about pain conditions. Improved pain knowledge changes attitudes and beliefs about pain, reduces destructive thoughts, and fear of pain, and improves physical performance. It is known to reduce pain and disability according to short-term results in patients with chronic pain with central sensitization. According to systematic reviews, PNE is moderately effective in patients with chronic musculoskeletal pain. In addition, it is stated that the use of educational approaches based on the neurophysiology of pain offers clinical benefits not only in physical terms but also in psychosocial terms. Since maladaptive psychosocial factors (for example, negative emotions, poor self-efficacy, and maladaptive beliefs) are associated with pain behaviors, it is thought that increasing pain knowledge will have an impact on pain perception. In a study conducted on patients with musculoskeletal pain who experience different types of pain, an inverse relationship between pain intensity and knowledge level was shown.
Due to the COVID-19 pandemic, the interest in the telerehabilitation method has increased, and it has become reachable easier with more evidence value on this subject. However, physiotherapists are healthcare professionals who work face-to-face with patients; depending on the pandemic curfews, the World Health Organization (WHO) has recommended not to continue face-to-face practices, except in emergencies, to protect patients' and physiotherapists' health. While digital options such as sensors, wearable technologies, virtual reality, and artificial intelligence are considered a solution, Tele-Rehabilitation (TR) can be the most practical, reachable, and cheaper solution to existing problems.
Systematic research and meta-analyses examining the effect of the telerehabilitation method and comparing it with traditional rehabilitation have revealed similar gains in outcome measures such as pain intensity and quality of life. It has been reported that simultaneous TR has comparable and effective results with face-to-face rehabilitation on pain and function in musculoskeletal problems. The telerehabilitation method is effective and cost-effective, especially in low back pain. Revealing the effects with more specific patient groups is the common recommendation of the studies.
In line with this information, the study's primary purpose is to determine the effects of PNE and progressive therapeutic exercise training given by the physiotherapist with the telerehabilitation method on pain, disability, pain beliefs, and quality of life. The secondary aim is to compare the effectiveness of progressive therapeutic exercise training alone or with PNE.
- Conditions
- Facet Joint Arthrosis, Low Back Pain
- Being tested
- Pain Neuroscience education + Progressive therapeutic exercise training, Progressive therapeutic exercise training
- Keywords
- facet joint arthrosis, low back pain, exercise, education, telerehabilitation
- Medical subject headings
- Low Back Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain Neuroscience education + Progressive therapeutic exercise trainingBehavioural
The education group will have a comprehensive patient education which includes; description, transmission, representation of pain, central sensitization, neuroplasticity, its relation to body systems, psychosocial and emotional factors affecting pain, pain behavior, and lifestyle changes to cope with pain, etc. Plus, the group will have supervised progressive therapeutic exercises via the telerehabilitation method.
Progressive therapeutic exercise trainingBehavioural
The exercise group will have supervised progressive therapeutic exercises via the telerehabilitation method.
| Study group | Role | What they receive |
|---|---|---|
| Education+Exercise Group | Experimental | Group 1: Patients will have 15 minutes of pain neuroscience education (PNE) and 30 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method. Receives: Behavioral: Pain Neuroscience education + Progressive therapeutic exercise training |
| Exercise group | Experimental | Group 2: Patients will have 45 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method. Receives: Behavioral: Progressive therapeutic exercise training |
| Control Group | No intervention | Group 3: Participants will be taken for the waiting list after evaluation with the telerehabilitation method. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Numerical Rating Scale
It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.
Measured: Pre - intervention
The Numerical Rating Scale
It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.
Measured: 6 weeks later (Post intervention)
The Oswestry Disability Index
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
Measured: Pre - intervention
The Oswestry Disability Index
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
Measured: 6 weeks later (Post intervention)
Secondary outcomes (6)
Active Straight Leg Raise Test
The ASLR test was performed with the patient in a supine position with straight legs and feet 20 cm apart. The first instruction to the patient was "Try to raise your legs, one after the other, above the couch 20 cm without bending the knee." The patient was asked to score impairment on a 6-point scale with the following choice options: 0 (not difficult at all), 1 (minimally difficult), 2 (somewhat difficult), 3 (fairly difficult), 4 (very difficult), 5 (unable to perform). The scores of both sides were added, with the summed score ranging from 0 to 10.
Measured: Pre - intervention
Active Straight Leg Raise Test
The ASLR test was performed with the patient in a supine position with straight legs and feet 20 cm apart. The first instruction to the patient was "Try to raise your legs, one after the other, above the couch 20 cm without bending the knee." The patient was asked to score impairment on a 6-point scale with the following choice options: 0 (not difficult at all), 1 (minimally difficult), 2 (somewhat difficult), 3 (fairly difficult), 4 (very difficult), 5 (unable to perform). The scores of both sides were added, with the summed score ranging from 0 to 10.
Measured: 6 weeks later (Post intervention)
The Short Form 12
It is a 12-item scale that evaluates the health-related quality of life, consisting of 8 sub-parameters, including physical function, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty, and mental status (Ware 1994, Demiral 2006). It is scored between 0 and 100; the higher the score, the better quality of life.
Measured: Pre - intervention
The Short Form 12
It is a 12-item scale that evaluates the health-related quality of life, consisting of 8 sub-parameters, including physical function, physical role difficulty, pain, general health, vitality, social function, emotional role difficulty, and mental status (Ware 1994, Demiral 2006). It is scored between 0 and 100; the higher the score, the better quality of life.
Measured: 6 weeks later (Post intervention)
The Pain Beliefs Questionnaire
Edwards et al. in 1992 developed to evaluate beliefs about the cause and treatment of pain (Edwards et al. 1992), validity in Turkish patients, and reliability study of the scale was conducted by Berk in 2006 (Berk, 2006). There are 12 items on this scale covering pain beliefs. Accordingly, it consisted of two test areas: Organic Beliefs consisting of 8 items and Psychological Beliefs consisting of 4 items. There is no cut-off point in the score. As the score increased, the internal consistency scores were measured with the Cronbach Alpha coefficient and reported as 0.71 for the Organic Beliefs subtest and 0.73 for the Psychological Beliefs subtest. The patient is asked to mark the most appropriate one for each item from 6 Likert-type options between 1: never and 6: always. The score for each subtest is calculated by adding the scores obtained from the items and dividing the number of items.
Measured: Pre - intervention
The Pain Beliefs Questionnaire
Edwards et al. in 1992 developed to evaluate beliefs about the cause and treatment of pain (Edwards et al. 1992), validity in Turkish patients, and reliability study of the scale was conducted by Berk in 2006 (Berk, 2006). There are 12 items on this scale covering pain beliefs. Accordingly, it consisted of two test areas: Organic Beliefs consisting of 8 items and Psychological Beliefs consisting of 4 items. There is no cut-off point in the score. As the score increased, the internal consistency scores were measured with the Cronbach Alpha coefficient and reported as 0.71 for the Organic Beliefs subtest and 0.73 for the Psychological Beliefs subtest. The patient is asked to mark the most appropriate one for each item from 6 Likert-type options between 1: never and 6: always. The score for each subtest is calculated by adding the scores obtained from the items and dividing the number of items.
Measured: 6 weeks later (Post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2021
- Study start15 Oct 2021
- Primary completion15 May 2022
- Study completion15 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Facet Joint ArthrosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Okan University
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Responsible party
- Principal investigator, Begüm Okudan, Okan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04981132
- Sponsor's protocol ID
- 0366
- Status last verified
- Aug 2023
- First submitted
- 21 Jun 2021
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther. 2011 Dec;16(6):544-9. doi: 10.1016/j.math.2011.05.003. Epub 2011 Jun 25.
PubMed 21705261Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.
PubMed 27141087Fatoye F, Gebrye T, Fatoye C, Mbada CE, Olaoye MI, Odole AC, Dada O. The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jun 24;8(6):e15375. doi: 10.2196/15375.
PubMed 32357128Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
PubMed 22133255Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
PubMed 27351541Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
PubMed 12443524Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.
PubMed 23238489Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
PubMed 29138049Saracoglu I, Arik MI, Afsar E, Gokpinar HH. The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial. Physiother Theory Pract. 2022 Jul;38(7):868-878. doi: 10.1080/09593985.2020.1809046. Epub 2020 Aug 19.
PubMed 32812478Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.
PubMed 24283249Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.
PubMed 32386218Wood L, Hendrick PA. A systematic review and meta-analysis of pain neuroscience education for chronic low back pain: Short-and long-term outcomes of pain and disability. Eur J Pain. 2019 Feb;23(2):234-249. doi: 10.1002/ejp.1314. Epub 2018 Oct 14.
PubMed 30178503Tahran O, Ersoz Huseyinsinoglu B, Yolcu G, Karadag Saygi E, Yeldan I. Comparing face-to-face and internet-based basic body awareness therapy for fibromyalgia: a randomized controlled trial. Disabil Rehabil. 2025 Sep;47(19):4987-4998. doi: 10.1080/09638288.2025.2465597. Epub 2025 Feb 19.
PubMed 39970076Okudan B, Celik D, Koban O. The effectiveness of telerehabilitation-based exercise combined with pain neuroscience education for patients with facet joint arthrosis: A randomized controlled study. Eur J Pain. 2024 Mar;28(3):382-395. doi: 10.1002/ejp.2187. Epub 2023 Sep 25.
PubMed 37747343
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Effectiveness of Pain and Exercise Training With Telerehabilitation Method in Patients With Low Back Pain Caused by Lumbar Facet Joint Arthrosis
- ClinicalTrials.gov ID
- NCT04981132
- Acronym / sponsor ID
- 0366
- Conditions
- Facet Joint Arthrosis, Low Back Pain
- Keywords
- facet joint arthrosis, low back pain, exercise, education, telerehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Okan UniversityUniversity, hospital or other
- Collaborators
- Istanbul University - Cerrahpasa
- Study start
- 15 Oct 2021 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 15 May 2022 (actual)
- First posted
- 28 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study investigates the effects of pain and exercise training via telerehabilitation method on pain, pain beliefs, trunk mobility, functionality, and quality of life in individuals with low back pain caused by facet joint arthrosis. Forty - five individuals are planning to include in the study. Participants will be randomly assigned to one of the three groups: Group 1: Pain education + exercise training group, Group 2: Exercise training group, and Group 3: Control group. The same physiotherapist will make evaluations via an online conference system. Group 1 will have pain neuroscience education and progressive therapeutic exercise training in a session for six weeks, twice a week, and Group 2 will have progressive therapeutic exercise training in a session for six weeks, twice a week, for six weeks, in total twelve sessions. Group 3 participants will be taken to the waiting list. Clinical and demographic data of the 45 participants in the study will be taken pre and post interventions. The primary outcomes are; the Numeric Pain Rating Scale (NPRS) and the Oswestry Disability Index (ODI). Secondary outcomes are the Active Straight Leg Raise Test (A- SLR), The Pain Belief Questionnaire (PBQ), and the Short Form Quality of Life Form (SF-12). Statistical analysis will be run through the SPSS 20.0 package program.
Detailed description
'Pain Neuroscience Education (PNE) is one of the cognitive approaches among conservative treatments, and has been one of the most inquisitive approaches. The content of the education includes the physiology of pain, types of pain, the areas in which it is represented in the brain, its effect on body image, and psychosocial dimensions. Education aims to break the patient's misinformation and perception about pain and teach how to manage pain. It aims to inform patients about the neurophysiological and neurobiological processes related to the pain experience and help change their misinformation about pain conditions. Improved pain knowledge changes attitudes and beliefs about pain, reduces destructive thoughts, and fear of pain, and improves physical performance. It is known to reduce pain and disability according to short-term results in patients with chronic pain with central sensitization. According to systematic reviews, PNE is moderately effective in patients with chronic musculoskeletal pain. In addition, it is stated that the use of educational approaches based on the neurophysiology of pain offers clinical benefits not only in physical terms but also in psychosocial terms. Since maladaptive psychosocial factors (for example, negative emotions, poor self-efficacy, and maladaptive beliefs) are associated with pain behaviors, it is thought that increasing pain knowledge will have an impact on pain perception. In a study conducted on patients with musculoskeletal pain who experience different types of pain, an inverse relationship between pain intensity and knowledge level was shown.
Due to the COVID-19 pandemic, the interest in the telerehabilitation method has increased, and it has become reachable easier with more evidence value on this subject. However, physiotherapists are healthcare professionals who work face-to-face with patients; depending on the pandemic curfews, the World Health Organization (WHO) has recommended not to continue face-to-face practices, except in emergencies, to protect patients' and physiotherapists' health. While digital options such as sensors, wearable technologies, virtual reality, and artificial intelligence are considered a solution, Tele-Rehabilitation (TR) can be the most practical, reachable, and cheaper solution to existing problems.
Systematic research and meta-analyses examining the effect of the telerehabilitation method and comparing it with traditional rehabilitation have revealed similar gains in outcome measures such as pain intensity and quality of life. It has been reported that simultaneous TR has comparable and effective results with face-to-face rehabilitation on pain and function in musculoskeletal problems. The telerehabilitation method is effective and cost-effective, especially in low back pain. Revealing the effects with more specific patient groups is the common recommendation of the studies.
In line with this information, the study's primary purpose is to determine the effects of PNE and progressive therapeutic exercise training given by the physiotherapist with the telerehabilitation method on pain, disability, pain beliefs, and quality of life. The secondary aim is to compare the effectiveness of progressive therapeutic exercise training alone or with PNE.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Education+Exercise Group | Experimental | Behavioral: Pain Neuroscience education + Progressive therapeutic exercise trainingGroup 1: Patients will have 15 minutes of pain neuroscience education (PNE) and 30 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method. |
| Exercise group | Experimental | Behavioral: Progressive therapeutic exercise trainingGroup 2: Patients will have 45 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method. |
| Control Group | No intervention | –Group 3: Participants will be taken for the waiting list after evaluation with the telerehabilitation method. |
Who may qualify
- Ages
- 40 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- volunteering,
- being the ages of 40 to 64
- having a diagnosis of Grade 1 or 2 facet joint arthrosis according to Pathria classification
- having pain for at least 12 weeks, primarily due to facet joint arthrosis
- having a pain score between 3 and 8 according to the Numerical Pain Scale (NRS)
Key exclusion criteria (7 listed)
- having a BMI of 30 and above
- to have had conservative treatment or surgery in the lumbar region in the last 6 months,
- having severe deformity in the lower extremity
- having red or orange (pregnancy, disc pathology, infection, fracture, cancer, stenosis, severe osteoporosis, schmorl nodule, cauda equina syndrome, etc.) signs defined for low back pain
- having a regular exercise habit,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pain Neuroscience education + Progressive therapeutic exercise trainingThe education group will have a comprehensive patient education which includes; description, transmission, representation of pain, central sensitization, neuroplasticity, its relation to body systems, psychosocial and emotional factors affecting pain, pain behavior, and lifestyle changes to cope with pain, etc. Plus, the group will have supervised progressive therapeutic exercises via the telerehabilitation method. | Behavioural | Education+Exercise Group |
| Progressive therapeutic exercise trainingThe exercise group will have supervised progressive therapeutic exercises via the telerehabilitation method. | Behavioural | Exercise group |
Primary outcome
The Numerical Rating Scale
Time frame: Pre - intervention
It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.
The Numerical Rating Scale
Time frame: 6 weeks later (Post intervention)
It is a frequently used scale with proven validity and reliability (Clark 2003, Boonstra 2008), consists of a horizontal line 100 mm long. There are two marks at the beginning and end of the line. The mark at the beginning of the line indicates 0 mm - no pain; the mark at the end of the line - 100 mm - unbearable pain. Subjects will be asked to place a mark on this horizontal line for the maximum pain they feel during rest and activity, and the results will be recorded in cm.
The Oswestry Disability Index
Time frame: Pre - intervention
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
The Oswestry Disability Index
Time frame: 6 weeks later (Post intervention)
The Oswestry Disability Index(ODI) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools. Scores between 0-5 are given for each question on the scale consisting of 10 questions. Questions are on travel, social life, sex life, sleeping, standing, sitting, walking, lifting things and personal precautions. Maximum score is 50, minimum score is 0.
6 secondary outcomes
Active Straight Leg Raise Test
Time frame: Pre - intervention
Active Straight Leg Raise Test
Time frame: 6 weeks later (Post intervention)
The Short Form 12
Time frame: Pre - intervention
The Short Form 12
Time frame: 6 weeks later (Post intervention)
The Pain Beliefs Questionnaire
Time frame: Pre - intervention
The Pain Beliefs Questionnaire
Time frame: 6 weeks later (Post intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Background: PubMed 21705261Clarke CL, Ryan CG, Martin DJ. Pain neurophysiology education for the management of individuals with chronic low back pain: systematic review and meta-analysis. Man Ther. 2011 Dec;16(6):544-9. doi: 10.1016/j.math.2011.05.003. Epub 2011 Jun 25.
- Background: PubMed 27141087Cottrell MA, Galea OA, O'Leary SP, Hill AJ, Russell TG. Real-time telerehabilitation for the treatment of musculoskeletal conditions is effective and comparable to standard practice: a systematic review and meta-analysis. Clin Rehabil. 2017 May;31(5):625-638. doi: 10.1177/0269215516645148. Epub 2016 May 2.
- Background: PubMed 32357128Fatoye F, Gebrye T, Fatoye C, Mbada CE, Olaoye MI, Odole AC, Dada O. The Clinical and Cost-Effectiveness of Telerehabilitation for People With Nonspecific Chronic Low Back Pain: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2020 Jun 24;8(6):e15375. doi: 10.2196/15375.
- Background: PubMed 22133255Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011 Dec;92(12):2041-56. doi: 10.1016/j.apmr.2011.07.198.
- Background: PubMed 27351541Louw A, Zimney K, Puentedura EJ, Diener I. The efficacy of pain neuroscience education on musculoskeletal pain: A systematic review of the literature. Physiother Theory Pract. 2016 Jul;32(5):332-55. doi: 10.1080/09593985.2016.1194646. Epub 2016 Jun 28.
- Background: PubMed 12443524Moseley L. Combined physiotherapy and education is efficacious for chronic low back pain. Aust J Physiother. 2002;48(4):297-302. doi: 10.1016/s0004-9514(14)60169-0.
- Background: PubMed 23238489Palacin-Marin F, Esteban-Moreno B, Olea N, Herrera-Viedma E, Arroyo-Morales M. Agreement between telerehabilitation and face-to-face clinical outcome assessments for low back pain in primary care. Spine (Phila Pa 1976). 2013 May 15;38(11):947-52. doi: 10.1097/BRS.0b013e318281a36c.
- Background: PubMed 29138049Bodes Pardo G, Lluch Girbes E, Roussel NA, Gallego Izquierdo T, Jimenez Penick V, Pecos Martin D. Pain Neurophysiology Education and Therapeutic Exercise for Patients With Chronic Low Back Pain: A Single-Blind Randomized Controlled Trial. Arch Phys Med Rehabil. 2018 Feb;99(2):338-347. doi: 10.1016/j.apmr.2017.10.016. Epub 2017 Nov 11.
- Background: PubMed 32812478Saracoglu I, Arik MI, Afsar E, Gokpinar HH. The effectiveness of pain neuroscience education combined with manual therapy and home exercise for chronic low back pain: A single-blind randomized controlled trial. Physiother Theory Pract. 2022 Jul;38(7):868-878. doi: 10.1080/09593985.2020.1809046. Epub 2020 Aug 19.
- Background: PubMed 24283249Truter P, Russell T, Fary R. The validity of physical therapy assessment of low back pain via telerehabilitation in a clinical setting. Telemed J E Health. 2014 Feb;20(2):161-7. doi: 10.1089/tmj.2013.0088. Epub 2013 Nov 27.
- Background: PubMed 32386218Turolla A, Rossettini G, Viceconti A, Palese A, Geri T. Musculoskeletal Physical Therapy During the COVID-19 Pandemic: Is Telerehabilitation the Answer? Phys Ther. 2020 Aug 12;100(8):1260-1264. doi: 10.1093/ptj/pzaa093. No abstract available.
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- WCPTLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pain Neuroscience education + Progressive therapeutic exercise training and Progressive therapeutic exercise training in people with Facet Joint Arthrosis and Low Back Pain, run by Okan University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Numerical Rating Scale (time frame: Pre - intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04981132, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.