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The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population

Primary Purpose

Chronic Low-back Pain, Sedentary Behavior

Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Reducing sedentary behaviour
Increase physical activity
Sponsored by
Vrije Universiteit Brussel
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain focused on measuring sedentary behaviour, sedentary lifestyle, desk-bound, chronic pain, long-lasting pain

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • CNLBP, for at least 3days/week for at least 3 months since the first symptoms.
  • Failed back surgery syndrome is allowed (ie, more than 3 years ago, anatomically successful operation without symptom disappearance)
  • Desk job, sedentary lifestyle (i.e. sitting for more than 6 hours per day). Given the greater risk of developing serious health problems when sitting for more than six hours a day.
  • 18-65 years old
  • Native Dutch speaker
  • Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments
  • Not undertaking exercise (>3 metabolic equivalents) 3 days before the assessments
  • Both sexes
  • Experiencing chronic neck pain is allowed if CNLBP is the dominant complaint.

Exclusion Criteria:

  • Any specific cause that can explain the CNLBP
  • Physically demanding job (e.g. nurses, paramedics, construction workers,...)
  • Chronic widespread pain (i.e. fibromyalgia, chronic fatigue syndrome)
  • Chronic systematic diseases such as rheumatoid arthritis, diabetes, etc.
  • Neuropathic pain
  • Being pregnant or pregnancy (including giving birth) in the preceding year
  • History of specific spinal surgery
  • Cinical depression

Sites / Locations

  • Vrije Universiteit BrusselRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

No Intervention

Experimental

Experimental

Arm Label

Control group

Reducing sedentary behavior

Increase physical activity

Arm Description

This group will be asked to maintain their daily routine.

This group needs to download an app on their computer and their smartphone. This app will give a notification every 30 minutes to walk during 2 minutes during working hours.

This group will be asked to be more physically active. They need to be active during 150min/week. Additionnaly they need to be active in periods of at least 10 minutes.

Outcomes

Primary Outcome Measures

The Brief Pain Inventory (short form)
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
The Brief Pain Inventory (short form)
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
The Brief Pain Inventory (short form)
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
The Brief Pain Inventory (short form)
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.

Secondary Outcome Measures

Algometry (pressure pain threshold)
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Algometry (pressure pain threshold)
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Algometry (pressure pain threshold)
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Algometry (pressure pain threshold)
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
The Brief Pain Inventory (Short form)
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
The Brief Pain Inventory (Short form)
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
The Brief Pain Inventory (Short form)
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
The Brief Pain Inventory (Short form)
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
Accelerometry (objective measures of physical activity and sedentary behavior)
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Accelerometry (objective measures of physical activity and sedentary behavior)
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Short Form 36 Health Status Survey (SF-36)
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Short Form 36 Health Status Survey (SF-36)
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Short Form 36 Health Status Survey (SF-36)
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Short Form 36 Health Status Survey (SF-36)
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.

Full Information

First Posted
October 15, 2020
Last Updated
September 21, 2022
Sponsor
Vrije Universiteit Brussel
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1. Study Identification

Unique Protocol Identification Number
NCT04610905
Brief Title
The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population
Official Title
The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 20, 2020 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vrije Universiteit Brussel

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The investigators will recruit participants between the age of 18 and 65 with chronic non-specific low back pain and a sedentary lifestyle. The participants will be randomly assigned to one of the three groups. The first group is the control group, the participants will be asked to continue their daily routine. The second group is an intervention group, sedentary behaviour will be reduced. In the third group participants will be asked to increase their physical activity up to 150min/week. The intervention takes place over a period of 6 weeks. After the intervention the pressure pain threshold will be measured, average steps will be measured (accelerometer) and a questionnaire needs to be filled out. These results will be compared to the results before the intervention and to the results of the other groups.
Detailed Description
The investigators will recruit participants between the age of 18 and 65 with chronic non-specific low back pain and a sedentary lifestyle. The partcipants will be randomly assigned to one of the three groups. The first group is the control group, the participants will be asked to not change their daily routine. In the first intervention group sedentary behaviour will be reduced. The participants will be asked to download an app on their smartphone and computer. This app will ask the participants to stand up and walk during 2 minutes to interrupt their sedentary behaviour during working hours. In the second intervention group participants will be asked to increase their physical activity. More specifically the participants will be asked to be active for a period of 150min/week. The intervention takes place over a period of 6 weeks. During these 6 weeks the participants needs to wear an accelerometer the first and the last week of the intervention. The week before the intervention a pre-measurement will take place, this means that the participant needs to wear an accelerometer during a week, fill out a questionnaire (BPI and SF-36) and the pressure pain threshold will be measured. After the intervention (6 weeks) the pressure pain threshold will be measured, average steps will be measured (accelerometer) and a questionnaire needs to be filled out. These results will be compared to the results before the intervention and to the results of the other groups. With this study the investigators will investigate whether less sedentary behavior or more physical activity are beneficial for chronic low-back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain, Sedentary Behavior
Keywords
sedentary behaviour, sedentary lifestyle, desk-bound, chronic pain, long-lasting pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
114 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
This group will be asked to maintain their daily routine.
Arm Title
Reducing sedentary behavior
Arm Type
Experimental
Arm Description
This group needs to download an app on their computer and their smartphone. This app will give a notification every 30 minutes to walk during 2 minutes during working hours.
Arm Title
Increase physical activity
Arm Type
Experimental
Arm Description
This group will be asked to be more physically active. They need to be active during 150min/week. Additionnaly they need to be active in periods of at least 10 minutes.
Intervention Type
Behavioral
Intervention Name(s)
Reducing sedentary behaviour
Intervention Description
This group needs to download an app on their computer and their smartphone. This app will give a notification every 30 minutes to walk during 2 minutes during working hours. The participants will receive a diary to write down whether they stand up.
Intervention Type
Behavioral
Intervention Name(s)
Increase physical activity
Intervention Description
This group will be asked to be more physically active. They need to be active during 150min/week. It can include walking, to ride a bike, jogging, tennis, football,... Additionnaly they need to be active in periods of at least 10 minutes. The participants will receive a diary to write down which activity they did and also for how long.
Primary Outcome Measure Information:
Title
The Brief Pain Inventory (short form)
Description
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
Time Frame
Baseline assessment (T0)
Title
The Brief Pain Inventory (short form)
Description
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
Time Frame
Directly post-intervention (6 weeks after baseline assessement)
Title
The Brief Pain Inventory (short form)
Description
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
Time Frame
3 month follow-up
Title
The Brief Pain Inventory (short form)
Description
Since chronic pain is a rather fluctuating condition, the question "Please rate your pain by circling the one number that best describes your pain on AVERAGE" is used as primary outcome measure to evaluate pain intensity. The answer to this question is formulated on an 11-point (i.e. 0-10) numeric rating scale (NRS), which is recommended as a core outcome measure in clinical trials of chronic pain. 0 indicates no pain, 10 indicates the worst pain imaginable.
Time Frame
6 month follow-up (go/ no go principe = if there is still a difference in behaviour between the groups after 3 months, we organize a 6m follow-up)
Secondary Outcome Measure Information:
Title
Algometry (pressure pain threshold)
Description
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Time Frame
Baseline assessment (T0)
Title
Algometry (pressure pain threshold)
Description
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Time Frame
Directly post-intervention (6 weeks after baseline assessement)
Title
Algometry (pressure pain threshold)
Description
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Time Frame
3 month follow-up
Title
Algometry (pressure pain threshold)
Description
Pressure pain thresholds will be assessed by using a handheld digital algometer. It evaluates the lowest stimulus in which a person perceives pain.
Time Frame
6 month follow-up. (go/ no go principe = if there is still a difference in behaviour between the groups after 3 months, we organize a 6m follow-up)
Title
The Brief Pain Inventory (Short form)
Description
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
Time Frame
Baseline Assessment (T0)
Title
The Brief Pain Inventory (Short form)
Description
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
Time Frame
Directly post-intervention (6 weeks after baseline assessement)
Title
The Brief Pain Inventory (Short form)
Description
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
Time Frame
3 month follow-up
Title
The Brief Pain Inventory (Short form)
Description
The BPI is a questionnaire to assess pain severity and degree of interference in daily functioning. Scores range from 0 to 10, with higher scores indicating more pain, or more pain interference.
Time Frame
6 month follow-up (go/ no go principe = if there is still a difference in behaviour between the groups after 3 months, we organize a 6m follow-up)
Title
Accelerometry (objective measures of physical activity and sedentary behavior)
Description
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Time Frame
Baseline assessment (T0)
Title
Accelerometry (objective measures of physical activity and sedentary behavior)
Description
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Time Frame
Directly post-intervention (6 weeks after baseline assessement)
Title
Short Form 36 Health Status Survey (SF-36)
Description
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Time Frame
Baseline assessment (T0)
Title
Short Form 36 Health Status Survey (SF-36)
Description
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Time Frame
Directly post-intervention (6 weeks after baseline assessement)
Title
Short Form 36 Health Status Survey (SF-36)
Description
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Time Frame
3 month follow-up
Title
Short Form 36 Health Status Survey (SF-36)
Description
The SF-36 is a questionnaire to consider the health- related quality of life. Scores on the SF36 range from 0 to 400, with higher scores indicating better health.
Time Frame
6 month follow-up ( (go/ no go principe = if there is still a difference in behaviour between the groups after 3 months, we organize a 6m follow-up)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: CNLBP, for at least 3days/week for at least 3 months since the first symptoms. Failed back surgery syndrome is allowed (ie, more than 3 years ago, anatomically successful operation without symptom disappearance) Desk job, sedentary lifestyle (i.e. sitting for more than 6 hours per day). Given the greater risk of developing serious health problems when sitting for more than six hours a day. 18-65 years old Native Dutch speaker Refraining from analgesics, caffeine, alcohol or nicotine in the previous 48h of the assessments Not undertaking exercise (>3 metabolic equivalents) 3 days before the assessments Both sexes Experiencing chronic neck pain is allowed if CNLBP is the dominant complaint. Exclusion Criteria: Any specific cause that can explain the CNLBP Physically demanding job (e.g. nurses, paramedics, construction workers,...) Chronic widespread pain (i.e. fibromyalgia, chronic fatigue syndrome) Chronic systematic diseases such as rheumatoid arthritis, diabetes, etc. Neuropathic pain Being pregnant or pregnancy (including giving birth) in the preceding year History of specific spinal surgery Cinical depression
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Anneleen Malfliet
Phone
+3224774503
Email
anneleen.malfliet@vub.be
First Name & Middle Initial & Last Name or Official Title & Degree
Tom Deliens
Email
tom.deliens@vub.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anneleen Malfliet, Prof. Dr.
Organizational Affiliation
Vrije Universiteit Brussel
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vrije Universiteit Brussel
City
Jette
State/Province
Brussels Hoofdstedelijk Gewest
ZIP/Postal Code
1090
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneleen Malfliet
Email
anneleen.malfliet@vub.be
First Name & Middle Initial & Last Name & Degree
Tom Deliens
Email
tom.deliens@vub.be

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population

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