The Effect of Attention Distraction on the Adherence to Exercise, in Chronic Low Back Pain Patients.
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Thessaly
About this trial
This randomized controlled trial aims to investigate whether the use of an attention distraction application during exercise increases patient adherence to exercise programs in chronic non-specific low back pain (CNSLBP). In addition, the study will examine whether higher adherence to exercise leads to improved outcomes in pain levels, functional capacity, kinesiophobia, quality of life, central sensitization, and pain catastrophizing.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age > 18 years
Chronic non-specific low back pain (≥3 months)
No physical therapy or structured exercise program in the last 3 months
Willingness to use the attention distraction application (for the AD-APP group)
Disqualifiers
History of spinal surgery
Neurological conditions affecting movement
Regular use of pain relief medication within the past two weeks
Pregnancy
Trial design
Design model
Parallel
Treatments tested in this trial
Stabilisation exercise, resistance exercise and distraction task
Other interventionThe 8-week exercise intervention consists of 25 minutes non supervised training while distracting their attention with a knowledge based application
stabilisation exercise and resistance exercises
Other interventionThe 8-week exercise intervention consists of 25 minutes non supervised training without distracting their attention with a knowledge based application
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Distraction GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
Adherence to exercise
Exercise Adherence Rating Scale in Greek (EARS-GR). The Exercise Adherence Rating Scale (EARS) is a questionnaire used to assess how well individuals adhere to prescribed exercise programs. It utilizes a 5-point Likert scale for each item, with higher scores indicating better adherence. The total score ranges from 0 to 24, with higher scores representing greater adherence.
Time frame
Baseline, Week 8, and follow-up (6 months).2
Adherence to exercise
Measured through app recorded metrics, including number of sessions (number)
Time frame
During the 6 month intervention period.3
Adherence to exercise
Measured through app recorded metrics, including duration per session (minutes)
Time frame
During the 6 month intervention period.4
Adherence to exercise
Measured through app recorded metrics including frequency of use per week (minutes)
Time frame
During the 6 month intervention periodSecondary outcomes
1
Pain Intensity
Numeric Pain Rating Scale (NPRS). The Numeric Pain Rating Scale (NPRS) is a widely used tool for assessing pain intensity, typically ranging from 0 to 10. In this scale, 0 represents no pain, and 10 represents the worst pain imaginable. Patients are asked to verbally select a number that best reflects their pain level.
Time frame
Baseline, Week 8, and follow-up (6 months).2
Anxiety, Stress, and Depression
Depression, Anxiety, and Stress Scale (DASS-21). The Depression Anxiety Stress Scales 21 (DASS-21) is scored by summing the responses to each of the three subscales: Depression, Anxiety, and Stress. Each subscale contains 7 items, and each item is scored on a scale of 0 to 3. The raw scores for each subscale are then multiplied by 2 to get the final score for each domain, which can range from 0 to 42.
Time frame
Baseline, Week 8, and follow-up (6 months).3
Functionality
Oswestry Disability Index (ODI). The Oswestry Disability Index (ODI) is scored out of a total of 50 points, with each of the 10 sections having a maximum score of 5. To calculate the ODI score, sum the scores for each section, divide by the total possible score (50), and multiply by 100 to express it as a percentage.
Time frame
Baseline, Week 8, and follow-up (6 months).4
Pain Catastrophizing
Pain Catastrophizing Scale (PCS). The Pain Catastrophizing Scale (PCS) is a 13-item questionnaire used to assess pain catastrophizing, with higher scores indicating greater levels of catastrophizing. Scores range from 0 to 52, and a score above 30 is considered clinically significant. The PCS also has three subscales: rumination, magnification, and helplessness.
Time frame
Baseline, Week 8, and follow-up (6 months).Sponsors and contacts
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Source ClinicalTrials.gov
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