Chronic Low-back PainCLBPEONCT05895630
Online Physical Exercise for Chronic Low Back Pain
A study testing Interactive physical exercise and Video physical exercise in people with Chronic Low-back Pain, run by Mathieu Roy at 2 sites in Canada.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- Interactive physical exercise and Video physical exercise
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 2 sitesCanada
- Study dates
- 1 Jun 2020to 31 Jul 2024
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
McGill University
Montreal, Quebec, H3A 1G1
Centre de recherche de l'Institut universitaire de gériatrie de Montréal
Montreal, Quebec
About this study
Official title: Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain
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.
Read the detailed description
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.
- Conditions
- Chronic Low-back Pain
- Being tested
- Interactive physical exercise, Video physical exercise
- Keywords
- Physical exercise, Telehealth, Remote interventions, Motivation, Proof-of-concept
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interactive physical exerciseBehavioural
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.
Video physical exerciseBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Interactive | Experimental | 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. Receives: Behavioral: Interactive physical exercise |
| Video | Experimental | 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. Receives: Behavioral: Video physical exercise |
| Control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline and 12 weeks
Secondary outcomes (43)
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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 metabolic equivalent minutes a week
Measured: Baseline and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Jun 2020
- Primary completion1 Jun 2024
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies 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
- Model description
- Three-arm parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mathieu Roy
- Sponsor type
- University, hospital or other
- Collaborators
- Université de Montréal, Université du Québec a Montréal, Concordia University, Montreal, Université du Québec à Trois-Rivières, Institut Universitaire de Gériatrie de Montréal
- Responsible party
- Sponsor-investigator, Mathieu Roy, McGill University
- Investigators
- Mathieu Roy, PhD, Principal investigator, McGill University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895630
- Sponsor's protocol ID
- CLBPEO
- Acronym
- CLBPEO
- Status last verified
- Nov 2024
- First submitted
- 3 May 2023
- Last updated
- 20 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):141-54. doi: 10.1016/j.berh.2011.02.005.
PubMed 22094191Lauze M, Martel DD, Aubertin-Leheudre M. Feasibility and Effects of a Physical Activity Program Using Gerontechnology in Assisted Living Communities for Older Adults. J Am Med Dir Assoc. 2017 Dec 1;18(12):1069-1075. doi: 10.1016/j.jamda.2017.06.030. Epub 2017 Aug 14.
PubMed 28818422Martel D, Lauze M, Agnoux A, Fruteau de Laclos L, Daoust R, Emond M, Sirois MJ, Aubertin-Leheudre M. Comparing the effects of a home-based exercise program using a gerontechnology to a community-based group exercise program on functional capacities in older adults after a minor injury. Exp Gerontol. 2018 Jul 15;108:41-47. doi: 10.1016/j.exger.2018.03.016. Epub 2018 Mar 22. No abstract available.
PubMed 29577975Barbosa Neves B, Franz R, Judges R, Beermann C, Baecker R. Can Digital Technology Enhance Social Connectedness Among Older Adults? A Feasibility Study. J Appl Gerontol. 2019 Jan;38(1):49-72. doi: 10.1177/0733464817741369. Epub 2017 Nov 22.
PubMed 29166818Angarita-Fonseca A, Page MG, Meloto CB, Gentile EL, Leonard G, Masse-Alarie H, Tufa I, Roy JS, Stone LS, Choiniere M, Fortin M, Roy M, Sean M, Tetreault P, Rainville P, Deslauriers S, Lacasse A; Quebec Back Pain Consortium; Quebec Back Pain Consortium. The Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research: reference values from the Quebec Low Back Pain Study. Pain. 2023 Feb 1;164(2):325-335. doi: 10.1097/j.pain.0000000000002703. Epub 2022 Jun 2.
PubMed 36638305
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05895630
- Acronym / sponsor ID
- CLBPEO / CLBPEO
- Conditions
- Chronic Low-back Pain
- Keywords
- Physical exercise, Telehealth, Remote interventions, Motivation, Proof-of-concept
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- Mathieu RoyUniversity, hospital or other
- Collaborators
- Université de Montréal, Université du Québec a Montréal, Concordia University, Montreal, Université du Québec à Trois-Rivières, Institut Universitaire de Gériatrie de Montréal
- Study start
- 1 Jun 2020 (actual)
- Primary completion
- 1 Jun 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 8 Jun 2023 (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.
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
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- Three-arm parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Interactive | Experimental | Behavioral: Interactive physical exerciseThe 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. |
| Video | Experimental | Behavioral: Video physical exerciseThe 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. |
| Control | No intervention | –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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (3 listed)
- 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)
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 |
|---|---|---|
| Interactive physical exerciseInteractive 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. | Behavioural | Interactive |
| Video physical exerciseIndividual 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. | Behavioural | Video |
Primary outcome
Change from baseline low back pain intensity at 12 weeks
Time frame: Baseline and 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).
43 secondary outcomes
Change from baseline pain spread at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline stomach pain at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline non-spine pain at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline headache at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline widespread pain at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline opioid use at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline injection use at 12 weeks
Time frame: Baseline and 12 weeks
Medical interventions: exercise therapy
Time frame: Baseline
Change from baseline psychological counseling use at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline pain interference with day-to-day activities at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline pain interference with work around home at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline pain interference with ability to participate in social activities at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline pain interference with household chores at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline physical function (household chores) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline physical function (ability to go up and downstairs) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline physical function (ability to go for a walk for at least 15 minutes) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline physical function (ability to run errands and shop) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline feelings of depression (worthlessness) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline feelings of depression (helplessness) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline feelings of depression at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline feelings of depression (hopelessness) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline sleep quality at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline quantity of refreshing sleep at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline extent of problems with sleep at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline difficulty falling asleep at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline absenteeism and compensation benefits (time off work) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline absenteeism and compensation benefits (disability/compensation) at 12 weeks
Time frame: Baseline and 12 weeks
Baseline low back pain-related lawsuits and legal claims
Time frame: Baseline
Follow-up low back pain-related lawsuits and legal claims
Time frame: 12 weeks
Change from baseline kinesiophobia at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline catastrophizing at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline substance abuse (item 1) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline substance abuse (item 2) at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline cigarette smoking at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Body Mass Index group at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Short Physical Performance Battery (SPPB) test score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Timed Up and Go (TUG) test score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Unipedal Stance test score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Lower Limb Strength test score at 12 weeks
Time frame: Baseline and 12 weeks
Change from baseline Lower Limb Strength Takai test score at 12 weeks
Time frame: Baseline and 12 weeks
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 20 Nov 2024.
- Background: PubMed 22094191Phillips K, Clauw DJ. Central pain mechanisms in chronic pain states--maybe it is all in their head. Best Pract Res Clin Rheumatol. 2011 Apr;25(2):141-54. doi: 10.1016/j.berh.2011.02.005.
- Background: PubMed 28818422Lauze M, Martel DD, Aubertin-Leheudre M. Feasibility and Effects of a Physical Activity Program Using Gerontechnology in Assisted Living Communities for Older Adults. J Am Med Dir Assoc. 2017 Dec 1;18(12):1069-1075. doi: 10.1016/j.jamda.2017.06.030. Epub 2017 Aug 14.
- Background: PubMed 29577975Martel D, Lauze M, Agnoux A, Fruteau de Laclos L, Daoust R, Emond M, Sirois MJ, Aubertin-Leheudre M. Comparing the effects of a home-based exercise program using a gerontechnology to a community-based group exercise program on functional capacities in older adults after a minor injury. Exp Gerontol. 2018 Jul 15;108:41-47. doi: 10.1016/j.exger.2018.03.016. Epub 2018 Mar 22. No abstract available.
- Background: PubMed 29166818Barbosa Neves B, Franz R, Judges R, Beermann C, Baecker R. Can Digital Technology Enhance Social Connectedness Among Older Adults? A Feasibility Study. J Appl Gerontol. 2019 Jan;38(1):49-72. doi: 10.1177/0733464817741369. Epub 2017 Nov 22.
- Background: PubMed 36638305Angarita-Fonseca A, Page MG, Meloto CB, Gentile EL, Leonard G, Masse-Alarie H, Tufa I, Roy JS, Stone LS, Choiniere M, Fortin M, Roy M, Sean M, Tetreault P, Rainville P, Deslauriers S, Lacasse A; Quebec Back Pain Consortium; Quebec Back Pain Consortium. The Canadian version of the National Institutes of Health minimum dataset for chronic low back pain research: reference values from the Quebec Low Back Pain Study. Pain. 2023 Feb 1;164(2):325-335. doi: 10.1097/j.pain.0000000000002703. Epub 2022 Jun 2.
- Fitbit news. The impact of coronavirus on Global activity, March 23, 2020Link provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Mathieu Roy, PhD principal investigator
McGill University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Interactive physical exercise and Video physical exercise in people with Chronic Low-back Pain, run by Mathieu Roy at 2 sites in Canada.
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 3 inclusion and 3 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 20 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. 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?
Change from baseline low back pain intensity at 12 weeks (time frame: Baseline and 12 weeks). 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 NCT05895630, which also lists 5 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 20 Nov 2024.