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

NCT04610905 | Terminated

• 1 other identifier: B1432020000219
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Low-back Pain; Sedentary Behavior

Keywords

sedentary behaviour; sedentary lifestyle; desk-bound; chronic pain; long-lasting pain

Outcome Measures

Primary Outcomes (4)

• 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)

• 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)

• 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

• 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 Outcomes (14)

• Algometry (pressure pain threshold)

  Baseline assessment (T0)

• Algometry (pressure pain threshold)

  Directly post-intervention (6 weeks after baseline assessement)

• Algometry (pressure pain threshold)

  3 month follow-up

• Algometry (pressure pain threshold)

  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)

  Baseline Assessment (T0)

Study Arms (3)

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.

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.

Behavioral: Increase physical activity

Interventions

Reducing sedentary behaviour BEHAVIORAL

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.

Reducing sedentary behavior

Increase physical activity BEHAVIORAL

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.

Increase physical activity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Vrije Universiteit Brussel: lead

Study Sites (1)

Vrije Universiteit Brussel

Jette, Brussels Capital, 1090, Belgium

Location

MeSH Terms

Conditions

Sedentary Behavior; Chronic Pain

Condition Hierarchy (Ancestors)

Behavior; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Anneleen Malfliet, Prof. Dr.

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor and postdoctoral researcher

Study Record Dates

• First Submitted: October 15, 2020
• First Posted: November 2, 2020
• Study Start: October 20, 2020
• Primary Completion: June 30, 2023
• Study Completion: August 31, 2023
• Last Updated: May 8, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)