Back to resultsImmediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Portugal
Study Type
Interventional
Intervention
Exercise at 60% vo2
Exercise at 90% vo2
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Inclusion Criteria:
- All groups:
- age between 18 and 65 years old
- Participants with low back pain:
- non-specific LBP (defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with pain referred down to the leg)
Exclusion Criteria:
- All groups:
- presence of pathology of the nervous system, cardiovascular or carcinogenic, rheumatic diseases (for example, rheumatoid arthritis), fibromyalgia, previous history of lumbar surgery, medication that affects or alters heart rate, any contraindication to exercise and pregnancy.
Sites / Locations
- Private Clinics of Physiotherapy
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Experimental
No Intervention
Arm Label
Exercise at 60% vo2
Exercise at 90% vo2
No intervention
Arm Description
This arm will receive 15 minutes of exercise at 60% VO2 max.
This arm will receive 15 minutes of exercise at 90% VO2 max.
No intervention
Outcomes
Primary Outcome Measures
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Secondary Outcome Measures
Aerobic capacity
Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.
Physical activity
Measured with the International Physical Activity Questionnaire. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week).
Anxiety and depression
Measured with the Hospital Anxiety and Depression Scale. This scale has 2 subscales, one for Anxiety and one for Depression both scored 0 to 21 and higher values represent higher levels of anxiety and depression.
Catastrophizing
Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Fear of movement
Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Disability
Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)
Pain phenotype
Measured with the Pain DETECT Scale. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of ) 12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of * 19 suggests that pain is likely to have a neuropathic component (> 90%).
Symptoms of central sensitization
Measured with the Central Sensitization Inventory. Score ranges from 0 to 100 and higher scores indicate higher symptoms of central sensitization.
Pain intensity
Assessed using the Visual Analogue Scale from 0 to 100 mm
Pain intensity
Assessed using the Visual Analogue Scale from 0 to 100 mm
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05077566
Brief Title
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Official Title
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 3, 2021 (Actual)
Primary Completion Date
August 1, 2022 (Actual)
Study Completion Date
February 15, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aveiro University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The main objective of this study is:
• To evaluate the immediate hypoalgesic effect of an aerobic exercise session of different intensities in patients with chronic low back pain;
The secondary objective is:
• To explore whether pain intensity, level of physical activity, functionality, catastrophizing, kinesiophobia, anxiety and depression interfere with the immediate hypoalgesic effect of exercise.
Detailed Description
There will be 3 groups of participants, an asymptomatic control group that will not perform any exercise and two groups of individuals with low back pain. One group will perform exercise at 90% VO2máx and the other at 60% VO2máx.
All the three groups will be assessed at baseline for pressure pain threshold, pain intensity, pain phenotype, disability, kinesiophobia, catastrophizing, anxiety and depression, physical activity, and aerobic capacity. In addition, pressure pain threshold and pain intensity will also be assessed at post-intervention.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
83 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise at 60% vo2
Arm Type
Active Comparator
Arm Description
This arm will receive 15 minutes of exercise at 60% VO2 max.
Arm Title
Exercise at 90% vo2
Arm Type
Experimental
Arm Description
This arm will receive 15 minutes of exercise at 90% VO2 max.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
No intervention
Intervention Type
Other
Intervention Name(s)
Exercise at 60% vo2
Intervention Description
15 minutes of exercise at 60% VO2 max.
Intervention Type
Other
Intervention Name(s)
Exercise at 90% vo2
Intervention Description
15 minutes of exercise at 90% VO2 max.
Primary Outcome Measure Information:
Title
Pressure pain threshold
Description
Pressure pain threshold measured with an algometer in Kgf
Time Frame
Baseline
Title
Pressure pain threshold
Description
Pressure pain threshold measured with an algometer in Kgf
Time Frame
Post-intervention (approximately 45 minutes after baseline)
Secondary Outcome Measure Information:
Title
Aerobic capacity
Description
Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.
Time Frame
Baseline
Title
Physical activity
Description
Measured with the International Physical Activity Questionnaire. Results can be reported in categories (low activity levels, moderate activity levels or high activity levels) or as a continuous variable (MET minutes a week).
Time Frame
Baseline
Title
Anxiety and depression
Description
Measured with the Hospital Anxiety and Depression Scale. This scale has 2 subscales, one for Anxiety and one for Depression both scored 0 to 21 and higher values represent higher levels of anxiety and depression.
Time Frame
Baseline
Title
Catastrophizing
Description
Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Time Frame
Baseline
Title
Fear of movement
Description
Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Time Frame
Baseline
Title
Disability
Description
Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)
Time Frame
Base
Title
Pain phenotype
Description
Measured with the Pain DETECT Scale. The final score between -1 and 38, indicates the likelihood of a neuropathic pain component. A score of ) 12 indicates that pain is unlikely to have a neuropathic component (< 15%), while a score of * 19 suggests that pain is likely to have a neuropathic component (> 90%).
Time Frame
Baseline
Title
Symptoms of central sensitization
Description
Measured with the Central Sensitization Inventory. Score ranges from 0 to 100 and higher scores indicate higher symptoms of central sensitization.
Time Frame
Baseline
Title
Pain intensity
Description
Assessed using the Visual Analogue Scale from 0 to 100 mm
Time Frame
Baseline
Title
Pain intensity
Description
Assessed using the Visual Analogue Scale from 0 to 100 mm
Time Frame
Post-intervention (approximately 45 minutes after baseline)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
All groups:
age between 18 and 65 years old
Participants with low back pain:
non-specific LBP (defined as pain between the costal margins and the inferior gluteal folds, which is usually accompanied by painful limitation of movement and may be associated with pain referred down to the leg)
Exclusion Criteria:
All groups:
presence of pathology of the nervous system, cardiovascular or carcinogenic, rheumatic diseases (for example, rheumatoid arthritis), fibromyalgia, previous history of lumbar surgery, medication that affects or alters heart rate, any contraindication to exercise and pregnancy.
Facility Information:
Facility Name
Private Clinics of Physiotherapy
City
Aveiro
Country
Portugal
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
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