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Completed

NCT Number: NCT05895630

Online Physical Exercise for 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.

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Key information

Conditions

Chronic Low-back Pain Behavior Motor Activity

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre de recherche de l'Institut universitaire de gériatrie de Montréal, Montreal, Quebec, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Interactive physical exercise

Behavioral

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

Behavioral

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.

Primary outcomes

  1. 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).

Secondary outcomes

  1. Change from baseline pain spread at 12 weeks

    Time frame: Baseline and 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

  2. Change from baseline stomach pain at 12 weeks

    Time frame: Baseline and 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

  3. Change from baseline non-spine pain at 12 weeks

    Time frame: Baseline and 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

  4. Change from baseline headache at 12 weeks

    Time frame: Baseline and 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

  5. Change from baseline widespread pain at 12 weeks

    Time frame: Baseline and 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

  6. Change from baseline opioid use at 12 weeks

    Time frame: Baseline and 12 weeks

    Has the patient used opioids (Yes/No/Not sure). Medical interventions item from the NIH Minimum Dataset for chronic low back pain

  7. Change from baseline injection use at 12 weeks

    Time frame: Baseline and 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

  8. Medical interventions: exercise therapy

    Time frame: Baseline

    Has the patient used exercise therapy (Yes/No/Not sure). Item from the NIH Minimum Dataset for chronic low back pain

  9. Change from baseline psychological counseling use at 12 weeks

    Time frame: Baseline and 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

  10. Change from baseline pain interference with day-to-day activities at 12 weeks

    Time frame: Baseline and 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

  11. Change from baseline pain interference with work around home at 12 weeks

    Time frame: Baseline and 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

  12. Change from baseline pain interference with ability to participate in social activities at 12 weeks

    Time frame: Baseline and 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

  13. Change from baseline pain interference with household chores at 12 weeks

    Time frame: Baseline and 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

  14. Change from baseline physical function (household chores) at 12 weeks

    Time frame: Baseline and 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

  15. Change from baseline physical function (ability to go up and downstairs) at 12 weeks

    Time frame: Baseline and 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

  16. 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

    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

  17. Change from baseline physical function (ability to run errands and shop) at 12 weeks

    Time frame: Baseline and 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

  18. Change from baseline feelings of depression (worthlessness) at 12 weeks

    Time frame: Baseline and 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

  19. Change from baseline feelings of depression (helplessness) at 12 weeks

    Time frame: Baseline and 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

  20. Change from baseline feelings of depression at 12 weeks

    Time frame: Baseline and 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

  21. Change from baseline feelings of depression (hopelessness) at 12 weeks

    Time frame: Baseline and 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

  22. Change from baseline sleep quality at 12 weeks

    Time frame: Baseline and 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

  23. Change from baseline quantity of refreshing sleep at 12 weeks

    Time frame: Baseline and 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

  24. Change from baseline extent of problems with sleep at 12 weeks

    Time frame: Baseline and 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

  25. Change from baseline difficulty falling asleep at 12 weeks

    Time frame: Baseline and 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

  26. Change from baseline absenteeism and compensation benefits (time off work) at 12 weeks

    Time frame: Baseline and 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

  27. Change from baseline absenteeism and compensation benefits (disability/compensation) at 12 weeks

    Time frame: Baseline and 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

  28. Baseline low back pain-related lawsuits and legal claims

    Time frame: Baseline

    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

  29. Follow-up low back pain-related lawsuits and legal claims

    Time frame: 12 weeks

    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

  30. Change from baseline kinesiophobia at 12 weeks

    Time frame: Baseline and 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

  31. Change from baseline catastrophizing at 12 weeks

    Time frame: Baseline and 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

  32. Change from baseline substance abuse (item 1) at 12 weeks

    Time frame: Baseline and 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

  33. Change from baseline substance abuse (item 2) at 12 weeks

    Time frame: Baseline and 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

  34. Change from baseline cigarette smoking at 12 weeks

    Time frame: Baseline and 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

  35. Change from baseline Body Mass Index group at 12 weeks

    Time frame: Baseline and 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

  36. Change from baseline Short Physical Performance Battery (SPPB) test score at 12 weeks

    Time frame: Baseline and 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).

  37. Change from baseline Timed Up and Go (TUG) test score at 12 weeks

    Time frame: Baseline and 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).

  38. Change from baseline Unipedal Stance test score at 12 weeks

    Time frame: Baseline and 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).

  39. Change from baseline Lower Limb Strength test score at 12 weeks

    Time frame: Baseline and 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).

  40. Change from baseline Lower Limb Strength Takai test score at 12 weeks

    Time frame: Baseline and 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).

  41. Change from baseline Gait Speed test score at 12 weeks

    Time frame: Baseline and 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).

  42. Change from baseline Rapid Assessment of Physical Activity (RAPA) test score at 12 weeks

    Time frame: Baseline and 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.

  43. Change from baseline International Physical Activity Questionnaire (IPAQ) test score at 12 weeks

    Time frame: Baseline and 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

Other outcomes

  1. Pain intensity before each training session

    Time frame: Assessed before each of the 36 training sessions

    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

  2. Pain intensity after each session

    Time frame: Assessed after each of the 36 training sessions

    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

  3. Pain intensity during the performance of physical tests at baseline

    Time frame: 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.

  4. Pain intensity during the performance of physical tests at follow-up

    Time frame: 12 weeks

    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.

  5. Program adherence

    Time frame: 12 weeks

    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.

Sponsors and collaborators

Lead sponsor

Mathieu Roy

Other

Collaborators

  • Concordia University, Montreal
  • Institut Universitaire de Gériatrie de Montréal
  • Université de Montréal
  • Université du Québec a Montréal
  • Université du Québec à Trois-Rivières

Registry information

Official study title

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

Acronym: CLBPEO

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jun 8, 2023
Registry last updated
Nov 20, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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