Clinical trial NCT04610905: 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
Overall status: TERMINATED
Phase: NA
Conditions: Chronic Low-back Pain
Sedentary Behavior
Keywords: sedentary behaviour
sedentary lifestyle
desk-bound
chronic pain
long-lasting pain
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The Brief Pain Inventory (short form)
timeFrame: Baseline assessment (T0)
measure: The Brief Pain Inventory (short form)
timeFrame: Directly post-intervention (6 weeks after baseline assessement)
measure: The Brief Pain Inventory (short form)
timeFrame: 3 month follow-up
measure: The Brief Pain Inventory (short form)
timeFrame: 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:
measure: Algometry (pressure pain threshold)
timeFrame: Baseline assessment (T0)
measure: Algometry (pressure pain threshold)
timeFrame: Directly post-intervention (6 weeks after baseline assessement)
measure: Algometry (pressure pain threshold)
timeFrame: 3 month follow-up
measure: Algometry (pressure pain threshold)
timeFrame: 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)
measure: The Brief Pain Inventory (Short form)
timeFrame: Baseline Assessment (T0)
measure: The Brief Pain Inventory (Short form)
timeFrame: Directly post-intervention (6 weeks after baseline assessement)
measure: The Brief Pain Inventory (Short form)
timeFrame: 3 month follow-up
measure: The Brief Pain Inventory (Short form)
timeFrame: 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)
measure: Accelerometry (objective measures of physical activity and sedentary behavior)
timeFrame: Baseline assessment (T0)
measure: Accelerometry (objective measures of physical activity and sedentary behavior)
timeFrame: Directly post-intervention (6 weeks after baseline assessement)
measure: Short Form 36 Health Status Survey (SF-36)
timeFrame: Baseline assessment (T0)
measure: Short Form 36 Health Status Survey (SF-36)
timeFrame: Directly post-intervention (6 weeks after baseline assessement)
measure: Short Form 36 Health Status Survey (SF-36)
timeFrame: 3 month follow-up
measure: Short Form 36 Health Status Survey (SF-36)
timeFrame: 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)
Other outcomes:
Locations:
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel
state: Brussels Hoofdstedelijk Gewest
Study officials:
affiliation: Vrije Universiteit Brussel
name: Anneleen Malfliet, Prof. Dr.
role: PRINCIPAL_INVESTIGATOR
References: