Online Physical Exercise for Chronic Low Back Pain

Study Overview
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Brief Summary
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This study aims to evaluate the effects of technology-based interventions, specifically web-based platforms, on outcomes of patients with chronic low back pain. The objectives are to develop and evaluate the feasibility and effectiveness of these interventions, and to examine factors such as age and gender on implementation and adherence. It consists of an interventional proof-of-concept pilot study with 45 participants randomly divided into 3 groups: an interactive physical activity group, a pre-recorded video physical activity group, and a control group. Assessments will be conducted at weeks 0 and 12 to measure pain intensity with the Canadian adaptation of the National Institutes of Health minimal dataset for chronic low back pain.

Detailed Description
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Technology-based interventions, specifically web-based platforms, have been used during the pandemic and, to a lower extent, prior to it, to maintain and improve physical and mental health while avoiding physical contact and therefore, risk of contagion, but also facilitating access to services such as psychotherapy or rehabilitation. Specifically, remote interventions have shown to be effective in the management of symptoms of people with chronic musculoskeletal pain, including chronic low back pain (CLBP). The objectives are to develop and evaluate the feasibility and effectiveness of these interventions, and to examine factors such as age and gender on implementation and adherence, as well as to validate the effectiveness of the interventions in improving CLBP outcomes and compare the effects of two different modalities of remote intervention (interactive and pre-recorded videos) against a waitlist control group. The study is an interventional proof-of-concept pilot study. Participants will be 45 people with CLBP aged 18 to 80 years who are able to consent, have no contraindication to physical activity, and can communicate, read, and understand French. Participants will be randomly divided into 3 groups: an interactive physical activity group, a video physical activity group, and a control group. Recruitment will be done from participant pools of the Quebec Pain Research Network, the Centre de Recherche de l'Institut Universitaire de Gériatrie de Montréal (CRIUGM), the Association Québécoise de la Douleur Chronique, and former participants of the laboratory's research projects. The intervention will last 12 weeks and consist of 3 physical activity sessions per week for the intervention groups. The interactive group sessions will be live via Zoom and the video sessions will consist of be pre-recorded videos. The control group will be instructed to continue their lifestyle habits throughout the study. Assessments will be conducted at weeks 0 and 12 via videoconference, telephone or lime-survey format to measure physical health, mental health, lifestyle, and quality of life. It will also evaluate the feasibility and adherence of the interactive or video technology. The study will also take into account age, gender and baseline pain intensity as potential confounding factors, by introducing them as covariates. We will use ANOVAs to compare the effects of the intervention on the variables of interest between groups. The primary variable will be pain intensity from the National Institutes of Health minimum dataset for chronic low back pain. Other variables form this dataset will be explored as secondary outcomes, along with variables related to physical performance. The study aims to recruit 60 participants, with a 25% dropout rate, to have a sample size of 45 participants completing the project in order to detect a small effect size.

Official Title
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Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain

Conditions
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Chronic Low-back Pain

Intervention / Treatment
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* Behavioral: Interactive physical exercise
* Behavioral: Video physical exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of chronic low back pain, lasting for more than 6 months To have an internet connection and access to a computer with webcam or tablet To be able to follow a physical activity program (measured by the QAAP questionnaire). Exclusion Criteria: Being under 18 years of age or over 80 years of age A history of psychiatric or neurological illness Presentation of neuropathic signs (radiating pain that spreads to the knee and leg (http://www.physio-pedia.com/Red_Flags_in_Spinal_Conditions)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Three-arm parallel randomized controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Interactive<br>The sessions will be given in groups of 5 to 10 people and will be interactive via Zoom (link will be sent to them by email). They will last 1h30min and will consist of 60min of physical activity, preceded and followed by 15 optional minutes of virtual social interaction with the kinesiologist and the other members of the group. Finally, if the participants are unable to attend the group session, a video of the course given will be available for them to follow afterwards via a website. | Behavioral: Interactive physical exercise<br>* Interactive remote sessions of physical exercise in groups of 10 patients. The sessions are categorized by level 1, 2 or 3 and the allocation to this level is decided according to a decision tree taking into account the mobility profile (balance and cardiomuscular health). The intervention will last 12 weeks. The sessions will be delivered 3 times per week (Monday, Wednesday, Friday) offering a total of approximately 180 min/week.<br>|
| Experimental: Video<br>The sessions will be done individually without interaction via pre-recorded videos. The videos demonstrate specific classes provided to the patients in this arm by a kinesiologist. Participants will be able to contact the kinesiologist by phone or email to ask questions about the sessions. The sessions will last 1h30min. | Behavioral: Video physical exercise<br>* Individual remote sessions of physical exercise based on pre-recorded videos. The video sessions are categorized by level 1, 2 or 3 and the allocation to this level is decided according to a decision tree taking into account the mobility profile (balance and cardiomuscular health). The videos will be delivered 3 times per week (Monday, Wednesday, Friday) offering a total of approximately 180 min/week.<br>|
| No Intervention: Control<br>The control will be instructed to continue their lifestyle habits throughout the study. These participants will not receive any intervention until their outcome measures at baseline and follow-up are recorded. At this point their participation is completed and they will be offered one of the two physical exercise programs. Therefore, this arm will be acting like a waitlist group. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline low back pain intensity at 12 weeks | Pain intensity perceived on average for the previous 7 days, reported in an 11-point numerical rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline pain spread at 12 weeks | Has back pain spread down the leg(s) during the past 2 weeks, Yes/No/Not sure. Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline stomach pain at 12 weeks | How much stomach pain bothered the patient during the past 4 weeks (Not bothered at all/Bothered a little/Bothered a lot). Item from the NIH (National Institutes of Health) Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline non-spine pain at 12 weeks | How much pain in the arms, legs, or joints other than the spine of back bothered the patient during the past 4 weeks (Not bothered at all/Bothered a little/Bothered a lot). Item from the NIH (National Institutes of Health) Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline headache at 12 weeks | How much headaches have bothered the patient during the past 4 weeks (Not bothered at all/Bothered a little/Bothered a lot). Item from the NIH (National Institutes of Health) Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline widespread pain at 12 weeks | How much widespread pain (pain all over the body) has bothered the patient during the past 4 weeks (Not bothered at all/Bothered a little/Bothered a lot). Item from the NIH (National Institutes of Health) Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline opioid use at 12 weeks | Has the patient used opioids (Yes/No/Not sure). Medical interventions item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline injection use at 12 weeks | Has the patient used injections (epidural, facet) (Yes/No/Not sure). Medical interventions item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Medical interventions: exercise therapy | Has the patient used exercise therapy (Yes/No/Not sure). Item from the NIH Minimum Dataset for chronic low back pain | Baseline | 
| Change from baseline psychological counseling use at 12 weeks | Has the patient used psychological counseling such as cognitive behavioral therapy (Yes/No/Not sure). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline pain interference with day-to-day activities at 12 weeks | Interference perceived on average for the previous 7 days, reported in an 5-point numerical rating scale from 1 (no interference) to 5 (maximum imaginable interference). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline pain interference with work around home at 12 weeks | Interference perceived on average for the previous 7 days, reported in an 5-point numerical rating scale from 1 (no interference) to 5 (maximum imaginable interference). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline pain interference with ability to participate in social activities at 12 weeks | Interference perceived on average for the previous 7 days, reported in an 5-point numerical rating scale from 1 (no interference) to 5 (maximum imaginable interference). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline pain interference with household chores at 12 weeks | Interference perceived on average for the previous 7 days, reported in an 5-point numerical rating scale from 1 (no pain) to 5 (maximum imaginable interference). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline physical function (household chores) at 12 weeks | Current ability to perform household chores, reported in an 5-point Likert scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline physical function (ability to go up and downstairs) at 12 weeks | Current ability to go up and downstairs, reported in an 5-point Likert scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline physical function (ability to go for a walk for at least 15 minutes) at 12 weeks | Current ability to go for a walk for at least 15 minutes, reported in an 5-point Likert scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline physical function (ability to run errands and shop) at 12 weeks | Current ability to run errands and shop, reported in an 5-point Likert scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline feelings of depression (worthlessness) at 12 weeks | Feeling worthless in the past 7 days, reported in an 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline feelings of depression (helplessness) at 12 weeks | Feeling helpless in the past 7 days, reported in an 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline feelings of depression at 12 weeks | Feeling depressed in the past 7 days, reported in an 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline feelings of depression (hopelessness) at 12 weeks | Feeling hopeless in the past 7 days, reported in an 5-point Likert scale (Never, Rarely, Sometimes, Often, Always). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline sleep quality at 12 weeks | Sleep quality in the past 7 days, reported in an 5-point Likert scale (Very poor, Poor, Fair, Good, Very good). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline quantity of refreshing sleep at 12 weeks | Refreshing sleep in the past 7 days, reported in an 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline extent of problems with sleep at 12 weeks | Problem with sleep in the past 7 days, reported in an 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline difficulty falling asleep at 12 weeks | Difficulty falling asleep in the past 7 days, reported in an 5-point Likert scale (Not at all, A little bit, Somewhat, Quite a bit, Very much). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline absenteeism and compensation benefits (time off work) at 12 weeks | I have been off work or unemployed for 1 month or more due to low back pain (Yes/No/NA). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline absenteeism and compensation benefits (disability/compensation) at 12 weeks | I receive or have applied for disability or workers compensation benefits because I am unable to work due to low back pain (Yes/No/NA). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Baseline low back pain-related lawsuits and legal claims | Are you involved in a lawsuit or legal claim related to your low back problem? (Yes/No/NA). Item from the NIH Minimum Dataset for chronic low back pain | Baseline | 
| Follow-up low back pain-related lawsuits and legal claims | Are you involved in a lawsuit or legal claim related to your low back problem? (Yes/No/NA). Item from the NIH Minimum Dataset for chronic low back pain | 12 weeks | 
| Change from baseline kinesiophobia at 12 weeks | Its not really safe for a person with my low back problem to be physically active (Agree/Disagree). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline catastrophizing at 12 weeks | I feel that my low back pain is terrible and never going to get any better (Agree/Disagree). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline substance abuse (item 1) at 12 weeks | Have you consumed alcohol or used drugs more than you meant to? (Never/Rarely/Sometimes/Often). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline substance abuse (item 2) at 12 weeks | Have you felt you wanted or needed to cut down on your drinking or drug abuse? (Never/Rarely/Sometimes/Often). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline cigarette smoking at 12 weeks | How would you describe your cigarette smoking? (Never smoked/Current smoker/Used to smoke, but have now quit). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline Body Mass Index group at 12 weeks | Body Mass Index Group (Normal weight/Underweight/Overweight/Obesity I/Obesity II/Obesity III). Item from the NIH Minimum Dataset for chronic low back pain | Baseline and 12 weeks | 
| Change from baseline Short Physical Performance Battery (SPPB) test score at 12 weeks | SPPB is a group of measures that combines the results of the gait speed, chair stand and balance tests. The scores range from 0 (worst performance) to 12 (best performance). Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Timed Up and Go (TUG) test score at 12 weeks | TUG test, subjects are asked to rise from a standard armchair, walk to a marker 3 m away, turn, walk back, and sit down again. Measured in seconds. Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Unipedal Stance test score at 12 weeks | Unipedal stance test. Functional test where subjects are required to stand on one leg with eyes open, and if possible with eyes closed. It is timed in seconds. Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Lower Limb Strength test score at 12 weeks | The 30-second chair stand involves recording the number of stands a person can complete in 30 seconds (measured in absolute number of repetitions). Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Lower Limb Strength Takai test score at 12 weeks | The Takai test is a 10 repetition chair stand, which involves recording the time it takes a person to complete 10 sit-to-stand repetitions (measured in seconds). Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Gait Speed test score at 12 weeks | Consists on walking 4 meters at the fastest speed possible, measured in seconds. Patients are also requested to rate the intensity of their low back pain before and after performing this test, in an 11-point numeric rating scale from 0 (no pain) to 10 (maximum imaginable pain). | Baseline and 12 weeks | 
| Change from baseline Rapid Assessment of Physical Activity (RAPA) test score at 12 weeks | RAPA scale uses 7 items rated from 1 to 7 points, with the respondent's score categorized into one of five levels of physical activity: 1 = sedentary, 2 = underactive, 3 = regular underactive (light activities), 4 = regular underactive, and 5 = regular active. | Baseline and 12 weeks | 
| Change from baseline International Physical Activity Questionnaire (IPAQ) test score at 12 weeks | The International Physical Activity Questionnaire is a 27-item self-reported measure of physical activity. It measures duration (minutes) and frequency (days) of physical activity in the last 7 days in domains of: Job-related, Transportation, Housework, house maintenance, caring for family, Recreation, sport, and leisure-time, Time spent sitting. The scoring provides a result in MET (metabolic equivalent) minutes a week | Baseline and 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical exercise, Telehealth, Remote interventions, Motivation, Proof-of-concept