Interactive and Adapted Physical Exercise for the Remote Management of Chronic Low Back Pain
Phase: NA
Conditions: Chronic Low-back Pain
Sponsor: Mathieu Roy

Official Title: 
Interactive and Adapted Physical Exercise for the Remote Management of 
Chronic Low Back Pain 
 
 
NCT number: Not Available 
Unique Protocol ID: CLBPEO 
 
 
Date: April 24th, 2023 
 
 

Project Protocol 
 
Experimental design 
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 
multiple locations across Montréal and the province of Québec. 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 interactive (and 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. 
 
Patient sample 
For this study, participants will be adults between 18 years and 80 years of age, 
presenting with chronic low back pain (CLBP) for more than 6 months. Patients selected 
will need to respond to the criteria established by the Canadian minimum dataset for 
CLBP (Lacasse et al., 2017). Other inclusion criteria will include having an internet 
connection and access to a computer with webcam or tablet and be able to follow a 
physical activity program, which will be assessed with the Questionnaire sur l’Aptitude 
à l’Activité Physique (QAAP questionnaire). Individuals with a history of psychiatric or 
neurological illness will be excluded. Participants will not be eligible for the study if they 
have neuropathic signs (radiating pain that spreads to the knee and leg 
(http://www.physio-pedia.com/Red_Flags_in_Spinal_Conditions).  

Participants will be recruited from: 1) the Quebec Pain Research Network (QPRN) 
participant pool (>3000 CLBP patients), 2) the Centre de Recherche de l'Institut 
Universitaire de Gériatrie de Montréal (CRIUGM) participant pool (>1000 seniors), 3) 
the Quebec Chronic Pain Association (QCPA) low back pain participant pool, 4) former 
participants of the laboratory's research projects who have agreed to be recontacted, 5) 
the pool of people with low back pain attending the Institut universitaire sur la 
réadaptation en déficience physique de Montréal and the Clinique d'adaptation à la 
douleur chronique du Centre de réadaptation Lucie-Bruneau. Participants will be 
randomly assigned to one of 3 groups. 
 
Dependent variables 
In addition to the inclusion criteria, assessments will be performed at weeks 0 
(pre) and 12 (post-intervention) following a videoconference or telephone format and 
using lime-survey©. This mode of evaluation is done to make long-term implantation 
feasible and flexible for any geographical location, and also in case of restrictions, 
including due to weather or the current pandemic. 
These assessments will measure: 
1) CLBP intensity using the national Institutes of Health minimum (NIH) dataset. 
The primary outcome will be 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) 
2) CLBP outcomes from the NIH minimum dataset, including: 5 dimensions of 
pain history, 4 dimensions of medical interventions for CLBP, 4 dimensions 
of pain interference, 4 dimensions of physical function, 4 dimensions of 
depressive symptoms, 4 dimensions of sleep, 2 items on absenteeism due to 

CLBP, Kinesiophobia, Pain catastrophizing, 2 items on substance abuse, 1 
item on smoking and the patient’s height and weight to calculate their body-
mass index 
3) Physical health (functional capacity: SPPB, unipodal balance, Timed Up and 
Go (TUG); physical performance: lower extremity power (10 repetition chair 
test, 30sec chair test), gait speed (4 minutes fastest possible gait). Patients will 
rate pain intensity before and after each of these tests in an 11-point numerical 
rating scale from 0 (no pain) to 10 (maximum imaginable pain) 
4) Pain intensity before and after each session attended. Participants will be 
asked to rate in an 11-point numerical rating scale from 0 (no pain) to 10 
(maximum imaginable pain), the low back pain intensity perceived while 
standing, lying down and walking, before and after each training session 
5) Finally, the adherence (number of sessions; minimum threshold of 75% to be 
considered complete, and 66% or 4/6 sessions in the last two weeks) to both 
remote interventions will be assessed. 
 
Independent variables 
A computer application (random-number generator) will be used to generate a 
randomization sequence and thus assign each patient to one of the three groups. The 
intervention will last 12 weeks. Physical activity sessions for both intervention groups 
will take place 3 times per week (Monday, Wednesday, Friday) providing a total of 
approximately 180 min/week. The intensity of each session is categorized by levels 1, 2 
or 3 and the allocation to this level is decided according to a decision tree taking into 
account the mobility profile of each participant (balance and cardiomuscular health). 

Interactive physical activity group (IPA, n=15): The sessions will be provided to 
groups of about 10 people and will be interactive via the Zoom conference medium (the 
link will be sent to them by email). They will last 1h30 min and will consist of 60 min of 
physical activity, preceded and followed by 15 optional minutes of virtual social 
interaction with the kinesiologist and the other members of the group. This training mode 
will allow the kinesiologist to correct the participants in real time during the sessions 
while creating a sense of belonging. 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. 
Virtual physical activity group (VPA, n=15): The sessions will be conducted 
individually without interaction via pre-recorded videos. The videos are identical to those 
of courses given by the kinesiologist to the IPA group. Participants will be able to contact 
the kinesiologist by phone or email to ask questions about the sessions. 
The control group (CTL, n=15) will be instructed to continue their lifestyle habits 
throughout the study. The interactive physical training program will be offered after the 
12-week wait. Participants in the control group will follow the training regimen of the 
IPA group. 
 
Procedures 
The study will have a total estimated duration of two years, during which each 
patient will participate in 36 sessions divided into 3 weekly sessions for 12 weeks. The 
research protocol consists of several stages. Initially, participants are contacted via 
telephone and administered a questionnaire. If they are deemed eligible for the study, they 
proceed to the next stage, otherwise, their participation is terminated at this stage. 
Participants who are eligible for the study are then given access to LimeSurvey, an online 

survey platform to provide questionnaire data. Eligible participants undergo an online 
physical evaluation via the Zoom platform, which also serves to confirm their 
recruitment. Only participants who successfully meet the inclusion criteria after 
completing the physical evaluation proceed to the next stage. 
 
At this point, participants are randomly allocated to either be placed on a waiting 
list, given access to receive videos (group VPA), or assigned to participate in the 
interactive Zoom classes (group IPA). Those on the waiting list are contacted for a final 
online evaluation at a later date. Participants in the VPA group are given access to a video 
platform and contacted for a final evaluation at a later date. Participants assigned to the 
IPA group are managed by Neuromotrix, a team of kinesiologists specialized in adapted 
physical activity. Neuromotrix provides them with three Zoom meetings per week and a 
reminder email on Sundays prior to every week. These participants are also contacted for 
an online final evaluation at a later date. All participants undergo a final physical 
assessment on the date of the final evaluation, after which they complete a final 
questionnaire on LimeSurvey. 
 
Statistical analysis plan 
Homoscedasticity will be verified using the Levene test. Descriptive statistics will 
be employed to define the sample characteristics. The main outcome variable (average 
pain intensity due to CLBP) will be compared between groups (IPA, VPA and CTL) over 
time at the primary endpoint (baseline and week 12) using a mixed analysis of variance 
(ANOVA). Other secondary outcomes will be similarly examined by using mixed 
ANOVAs to compare groups and effects. Age, gender and baseline pain intensity will be 
used as covariates. For exploratory purposes, changes in pain intensity (delta = post – pre) 

before and after each session will be averaged across sessions and the means compared 
within and between groups to evaluate acute changes in pain intensity (positive or 
negative) immediately after the exercise session. In addition, the mean rate of attendance 
to sessions in the IPA and VPA groups will be compared by means of a non-paired t-test 
to interpret adherence data. 
 
References 
 
Lacasse A, Roy JS, Parent AJ, Noushi N, Odenigbo C, Page G, Beaudet N, Choiniere M, et 
al. (2017), The Canadian minimum dataset for chronic low back pain research: a cross-
cultural adaptation of the National Institutes of Health Task Force Research Standards. 
CMAJ Open 5:E237-E248.