Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
1 other identifier
interventional
83
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable low-back-pain
Started Oct 2021
Typical duration for not_applicable low-back-pain
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 1, 2021
CompletedStudy Start
First participant enrolled
October 3, 2021
CompletedFirst Posted
Study publicly available on registry
October 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2023
CompletedFebruary 21, 2023
February 1, 2023
10 months
October 1, 2021
February 17, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Baseline
Pressure pain threshold
Pressure pain threshold measured with an algometer in Kgf
Post-intervention (approximately 45 minutes after baseline)
Secondary Outcomes (10)
Aerobic capacity
Baseline
Physical activity
Baseline
Anxiety and depression
Baseline
Catastrophizing
Baseline
Fear of movement
Baseline
- +5 more secondary outcomes
Study Arms (3)
Exercise at 60% vo2
ACTIVE COMPARATORThis arm will receive 15 minutes of exercise at 60% VO2 max.
Exercise at 90% vo2
EXPERIMENTALThis arm will receive 15 minutes of exercise at 90% VO2 max.
No intervention
NO INTERVENTIONNo intervention
Interventions
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Private Clinics of Physiotherapy
Aveiro, Portugal
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
October 1, 2021
First Posted
October 14, 2021
Study Start
October 3, 2021
Primary Completion
August 1, 2022
Study Completion
February 15, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02
Data Sharing
- IPD Sharing
- Will not share