Online Physical Exercise for Chronic Low Back Pain

Chronic Low-back Pain Clinical Trial

— CLBPEO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05895630
• Other study ID #: CLBPEO
• Status: Recruiting
• Phase: N/A
• Start date: June 1, 2020
• Est. completion date: June 2024

Study information

• Verified date: April 2024
• Source: McGill University
• Contact: Carlos Gevers-Montoro, PhD (cand)
• Phone: 8199790448
• Email: carlos.gevers.montoro[@]uqtr.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

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)

Related Conditions & MeSH terms

• Back Pain
• Chronic Low-back Pain
• Low Back Pain

Intervention

Behavioral:
• Interactive physical exercise
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 exercise
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.

Locations

Country	Name	City	State
Canada	Centre de recherche de l'Institut universitaire de gériatrie de Montréal	Montréal	Quebec
Canada	McGill University	Montréal	Quebec

Sponsors (6)

Lead Sponsor	Collaborator
McGill University	Concordia University, Montreal, Institut Universitaire de Gériatrie de Montréal, Université de Montréal, Université du Québec a Montréal, Université du Québec à Trois-Rivières

Country where clinical trial is conducted

Canada, 

References & Publications (5)

Angarita-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. — View Citation

Barbosa 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. — View Citation

Lauze 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. — View Citation

Martel 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain intensity before each training session	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	Assessed before each of the 36 training sessions
Other	Pain intensity after each session	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	Assessed after each of the 36 training sessions
Other	Pain intensity during the performance of physical tests at baseline	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 during the SPPB, TUG, balance, lower limb strength and gait speed tests.	Baseline
Other	Pain intensity during the performance of physical tests at follow-up	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 during the SPPB, TUG, balance, lower limb strength and gait speed tests.	12 weeks
Other	Program adherence	Adherence to the exercise programs will be assessed using the percentage of sessions attended. Participation = 75% is considered necessary to be able to deem the program complete. In addition, a minimum of 66% of adherence (4/6 sessions) during the last two weeks will be required.	12 weeks
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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	Baseline and 12 weeks

External Links

•   Fitbit news. The impact of coronavirus on Global activity, March 23, 2020
•   Walter R. Thompson. World Health Organization Study Reinforces Worldwide Pandemic of Physical Inactivity. American College of Sport Medecine (ACSM) 2018.