Chronic Low-back Pain Clinical Trial
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
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.
Status | Recruiting |
Enrollment | 114 |
Est. completion date | August 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | Vrije Universiteit Brussel | Jette | Brussels Hoofdstedelijk Gewest |
Lead Sponsor | Collaborator |
---|---|
Vrije Universiteit Brussel |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Baseline assessment (T0) | |
Primary | 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. | Directly post-intervention (6 weeks after baseline assessement) | |
Primary | 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. | 3 month follow-up | |
Primary | 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. | 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 | 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. | Baseline assessment (T0) | |
Secondary | 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. | Directly post-intervention (6 weeks after baseline assessement) | |
Secondary | 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. | 3 month follow-up | |
Secondary | 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. | 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 | 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. | Baseline Assessment (T0) | |
Secondary | 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. | Directly post-intervention (6 weeks after baseline assessement) | |
Secondary | 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. | 3 month follow-up | |
Secondary | 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. | 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 | Accelerometry (objective measures of physical activity and sedentary behavior) | With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured. | Baseline assessment (T0) | |
Secondary | Accelerometry (objective measures of physical activity and sedentary behavior) | With a hip-worn accelerometer sedentary behavior and physical acitvity will be objectively measured. | Directly post-intervention (6 weeks after baseline assessement) | |
Secondary | 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. | Baseline assessment (T0) | |
Secondary | 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. | Directly post-intervention (6 weeks after baseline assessement) | |
Secondary | 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. | 3 month follow-up | |
Secondary | 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. | 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) |
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