Effectiveness of Pain and Exercise Training With Telerehabilitation on Lumbar Facet Joint Arthrosis

August 22, 2023 updated by: Begüm Okudan, Okan University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Istanbul, Turkey
        • Istanbul University - Cerrahpasa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Education+Exercise Group
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.
Behavioral: Pain Neuroscience education + Progressive therapeutic exercise training
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.
Experimental: Exercise group
Group 2: Patients will have 45 minutes of progressive therapeutic exercise training (PTE) with the telerehabilitation method.
Behavioral: Progressive therapeutic exercise training
The exercise group will have supervised progressive therapeutic exercises via the telerehabilitation method.
No Intervention: Control Group
Group 3: Participants will be taken for the waiting list after evaluation with the telerehabilitation method.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Pre - intervention
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.
6 weeks later (Post intervention)
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.
Pre - intervention
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 weeks later (Post intervention)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Active Straight Leg Raise Test
Time Frame: Pre - intervention
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.
Pre - intervention
Active Straight Leg Raise Test
Time Frame: 6 weeks later (Post intervention)
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.
6 weeks later (Post intervention)
The Short Form 12
Time Frame: Pre - intervention
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.
Pre - intervention
The Short Form 12
Time Frame: 6 weeks later (Post intervention)
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.
6 weeks later (Post intervention)
The Pain Beliefs Questionnaire
Time Frame: Pre - intervention
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.
Pre - intervention
The Pain Beliefs Questionnaire
Time Frame: 6 weeks later (Post intervention)
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.
6 weeks later (Post intervention)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Okan University

Collaborators

Istanbul University - Cerrahpasa (IUC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2021

Primary Completion (Actual)

May 15, 2022

Study Completion (Actual)

May 15, 2022

Study Registration Dates

First Submitted

June 21, 2021

First Submitted That Met QC Criteria

July 17, 2021

First Posted (Actual)

July 28, 2021

Study Record Updates

Last Update Posted (Actual)

August 24, 2023

Last Update Submitted That Met QC Criteria

August 22, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0366

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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