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

NCT ID: NCT04610905

Last Updated: 2024-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-10-20
• Study Completion Date: 2023-08-31

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.

Conditions

Chronic Low-back Pain; Sedentary Behavior

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Control group

This group will be asked to maintain their daily routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reducing sedentary behavior

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.

Group Type: EXPERIMENTAL

Reducing sedentary behaviour

Intervention Type: 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.

Increase physical activity

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.

Group Type: EXPERIMENTAL

Increase physical activity

Intervention Type: 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.

Interventions

Reducing sedentary behaviour

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

Increase physical activity

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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vrije Universiteit Brussel

OTHER

Sponsor Role: lead

Responsible Party

Malfliet Anneleen

Assistant professor and postdoctoral researcher

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Anneleen Malfliet, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

Vrije Universiteit Brussel

Locations

Vrije Universiteit Brussel

Jette, Brussels Capital, Belgium

Countries

Belgium

Other Identifiers

B1432020000219

Identifier Type: -

Identifier Source: org_study_id