Low Back PainNCT05077566
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
A study testing Exercise at 60% vo2 and Exercise at 90% vo2 in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Exercise at 60% vo2 and Exercise at 90% vo2
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 1 sitePortugal
- Study dates
- 3 Oct 2021to 15 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Low Back Pain
- Being tested
- Exercise at 60% vo2, Exercise at 90% vo2
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise at 60% vo2Other
15 minutes of exercise at 60% VO2 max.
Exercise at 90% vo2Other
15 minutes of exercise at 90% VO2 max.
| Study group | Role | What they receive |
|---|---|---|
| Exercise at 60% vo2 | Active comparator | This arm will receive 15 minutes of exercise at 60% VO2 max. Receives: Other: Exercise at 60% vo2 |
| Exercise at 90% vo2 | Experimental | This arm will receive 15 minutes of exercise at 90% VO2 max. Receives: Other: Exercise at 90% vo2 |
| No intervention | No intervention | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Measured: Baseline
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Measured: Post-intervention (approximately 45 minutes after baseline)
Secondary outcomes (10)
Aerobic capacity
Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.
Measured: Baseline
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).
Measured: Baseline
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.
Measured: Baseline
Catastrophizing
Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Measured: Baseline
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)
Measured: Baseline
Disability
Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)
Measured: Base
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%).
Measured: Baseline
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.
Measured: Baseline
Pain intensity
Assessed using the Visual Analogue Scale from 0 to 100 mm
Measured: Baseline
Pain intensity
Assessed using the Visual Analogue Scale from 0 to 100 mm
Measured: Post-intervention (approximately 45 minutes after baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start3 Oct 2021
- Primary completion1 Aug 2022
- Study completion15 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aveiro University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anabela G Silva, Aveiro University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05077566
- Sponsor's protocol ID
- CED8_2021
- Status last verified
- Feb 2023
- First submitted
- 1 Oct 2021
- Last updated
- 21 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT05077566
- Acronym / sponsor ID
- CED8_2021
- Conditions
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Aveiro UniversityUniversity, hospital or other
- Study start
- 3 Oct 2021 (actual)
- Primary completion
- 1 Aug 2022 (actual)
- Study completion
- 15 Feb 2023 (actual)
- First posted
- 14 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise at 60% vo2 | Active comparator | Other: Exercise at 60% vo2This arm will receive 15 minutes of exercise at 60% VO2 max. |
| Exercise at 90% vo2 | Experimental | Other: Exercise at 90% vo2This arm will receive 15 minutes of exercise at 90% VO2 max. |
| No intervention | No intervention | –No intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise at 60% vo215 minutes of exercise at 60% VO2 max. | Other | Exercise at 60% vo2 |
| Exercise at 90% vo215 minutes of exercise at 90% VO2 max. | Other | Exercise at 90% vo2 |
Primary outcome
Pressure pain threshold
Time frame: Baseline
Pressure pain threshold measured with an algometer in Kgf
Pressure pain threshold
Time frame: Post-intervention (approximately 45 minutes after baseline)
Pressure pain threshold measured with an algometer in Kgf
10 secondary outcomes
Aerobic capacity
Time frame: Baseline
Physical activity
Time frame: Baseline
Anxiety and depression
Time frame: Baseline
Catastrophizing
Time frame: Baseline
Fear of movement
Time frame: Baseline
Disability
Time frame: Base
Pain phenotype
Time frame: Baseline
Symptoms of central sensitization
Time frame: Baseline
Pain intensity
Time frame: Baseline
Pain intensity
Time frame: Post-intervention (approximately 45 minutes after baseline)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2023.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise at 60% vo2 and Exercise at 90% vo2 in people with Low Back Pain, run by Aveiro University at 1 site in Portugal.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Portugal. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pressure pain threshold (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2023.