Chronic Low-back PainNCT04610905
The Effect of Reducing Sedentary Behaviour in Comparison to Promoting Physical Activity on Chronic Non-specific Low Back Pain in a Sedentary Population
A study testing Reducing sedentary behaviour and Increase physical activity in people with Chronic Low-back Pain and Sedentary Behavior, run by Vrije Universiteit Brussel at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low-back Pain, Sedentary Behavior
- What is being tested?
- Reducing sedentary behaviour and Increase physical activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteBelgium
- Study dates
- 20 Oct 2020to 31 Aug 2023
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Chronic Low-back Pain, Sedentary Behavior
- Being tested
- Reducing sedentary behaviour, Increase physical activity
- Keywords
- sedentary behaviour, sedentary lifestyle, desk-bound, chronic pain, long-lasting pain
- Medical subject headings
- Sedentary Behavior, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reducing sedentary behaviourBehavioural
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.
Increase physical activityBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | This group will be asked to maintain their daily routine. |
| Reducing sedentary behavior | Experimental | 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. Receives: Behavioral: Reducing sedentary behaviour |
| Increase physical activity | Experimental | 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. Receives: Behavioral: Increase physical activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline assessment (T0)
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.
Measured: Directly post-intervention (6 weeks after baseline assessement)
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.
Measured: 3 month follow-up
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.
Measured: 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 outcomes (14)
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.
Measured: Baseline assessment (T0)
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.
Measured: Directly post-intervention (6 weeks after baseline assessement)
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.
Measured: 3 month follow-up
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.
Measured: 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)
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.
Measured: Baseline Assessment (T0)
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.
Measured: Directly post-intervention (6 weeks after baseline assessement)
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.
Measured: 3 month follow-up
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.
Measured: 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)
Accelerometry (objective measures of physical activity and sedentary behavior)
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Measured: Baseline assessment (T0)
Accelerometry (objective measures of physical activity and sedentary behavior)
With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured.
Measured: Directly post-intervention (6 weeks after baseline assessement)
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.
Measured: Baseline assessment (T0)
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.
Measured: Directly post-intervention (6 weeks after baseline assessement)
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.
Measured: 3 month follow-up
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.
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start20 Oct 2020
- Primary completion30 Jun 2023
- Study completion31 Aug 2023
Why it stopped: Recruitment hampered
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- More trials run by Vrije Universiteit BrusselThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vrije Universiteit Brussel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malfliet Anneleen, Vrije Universiteit Brussel
- Investigators
- Anneleen Malfliet, Prof. Dr., Principal investigator, Vrije Universiteit Brussel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04610905
- Sponsor's protocol ID
- B1432020000219
- Status last verified
- May 2024
- First submitted
- 15 Oct 2020
- Last updated
- 8 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04610905
- Acronym / sponsor ID
- B1432020000219
- Conditions
- Chronic Low-back Pain, Sedentary Behavior
- Keywords
- sedentary behaviour, sedentary lifestyle, desk-bound, chronic pain, long-lasting pain
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Recruitment hampered
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Vrije Universiteit BrusselUniversity, hospital or other
- Study start
- 20 Oct 2020 (actual)
- Primary completion
- 30 Jun 2023 (actual)
- Study completion
- 31 Aug 2023 (actual)
- First posted
- 2 Nov 2020 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –This group will be asked to maintain their daily routine. |
| Reducing sedentary behavior | Experimental | Behavioral: Reducing sedentary behaviourThis 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. |
| Increase physical activity | Experimental | Behavioral: Increase physical activityThis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Reducing sedentary behaviourThis 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. | Behavioural | Reducing sedentary behavior |
| Increase physical activityThis 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. | Behavioural | Increase physical activity |
Primary outcome
The Brief Pain Inventory (short form)
Time frame: Baseline assessment (T0)
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)
Time frame: Directly post-intervention (6 weeks after baseline assessement)
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)
Time frame: 3 month follow-up
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)
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)
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.
14 secondary outcomes
Algometry (pressure pain threshold)
Time frame: Baseline assessment (T0)
Algometry (pressure pain threshold)
Time frame: Directly post-intervention (6 weeks after baseline assessement)
Algometry (pressure pain threshold)
Time frame: 3 month follow-up
Algometry (pressure pain threshold)
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)
The Brief Pain Inventory (Short form)
Time frame: Baseline Assessment (T0)
The Brief Pain Inventory (Short form)
Time frame: Directly post-intervention (6 weeks after baseline assessement)
The Brief Pain Inventory (Short form)
Time frame: 3 month follow-up
The Brief Pain Inventory (Short form)
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)
Accelerometry (objective measures of physical activity and sedentary behavior)
Time frame: Baseline assessment (T0)
Accelerometry (objective measures of physical activity and sedentary behavior)
Time frame: Directly post-intervention (6 weeks after baseline assessement)
Short Form 36 Health Status Survey (SF-36)
Time frame: Baseline assessment (T0)
Short Form 36 Health Status Survey (SF-36)
Time frame: Directly post-intervention (6 weeks after baseline assessement)
Short Form 36 Health Status Survey (SF-36)
Time frame: 3 month follow-up
Short Form 36 Health Status Survey (SF-36)
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)
Results and safety
The study was stopped early (reason given: Recruitment hampered). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2024.
- 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.
Anneleen Malfliet, Prof. Dr. principal investigator
Vrije Universiteit Brussel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reducing sedentary behaviour and Increase physical activity in people with Chronic Low-back Pain and Sedentary Behavior, run by Vrije Universiteit Brussel at 1 site in Belgium.
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 9 inclusion and 8 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: stopped early, as of the sponsor's last update on 8 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. 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 was stopped early (reason given: Recruitment hampered). Results are not available in the source record.
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?
The Brief Pain Inventory (short form) (time frame: Baseline assessment (T0)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 May 2024.