Clinical trial NCT04981132: Effectiveness of Pain and Exercise Training With Telerehabilitation on Lumbar Facet Joint Arthrosis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Facet Joint Arthrosis
Low Back Pain
Keywords: facet joint arthrosis
low back pain
exercise
education
telerehabilitation
Lead sponsor: Okan University
Sponsor class: OTHER
Collaborators: name: Istanbul University - Cerrahpasa
First posted: 2021-07-28
Enrollment: 45
Sex: ALL
Minimum age (years): 40
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.

Primary outcomes:
measure: The Numerical Rating Scale
timeFrame: Pre - intervention
measure: The Numerical Rating Scale
timeFrame: 6 weeks later (Post intervention)
measure: The Oswestry Disability Index
timeFrame: Pre - intervention
measure: The Oswestry Disability Index
timeFrame: 6 weeks later (Post intervention)
Secondary outcomes:
measure: Active Straight Leg Raise Test
timeFrame: Pre - intervention
measure: Active Straight Leg Raise Test
timeFrame: 6 weeks later (Post intervention)
measure: The Short Form 12
timeFrame: Pre - intervention
measure: The Short Form 12
timeFrame: 6 weeks later (Post intervention)
measure: The Pain Beliefs Questionnaire
timeFrame: Pre - intervention
measure: The Pain Beliefs Questionnaire
timeFrame: 6 weeks later (Post intervention)
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Istanbul University - Cerrahpaşa
Study officials:
References:
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