Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain

Not Applicable

Completed

• Conditions: Low Back Pain
• Interventions: Other: Exercise at 90% vo2; Other: Exercise at 60% vo2

• Registration Number: NCT05077566
• Lead Sponsor: Aveiro University

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.

Study Timeline

• Study First Submitted: 2021-10-01
• Study First Submitted QC: 2021-10-01
• Study Start: 2021-10-03
• Study First Posted: 2021-10-14
• Primary Completion: 2022-08-01
• Status Verified: 2023-02
• Study Completion: 2023-02-15
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Exercise at 90% vo2	Exercise at 90% vo2	This arm will receive 15 minutes of exercise at 90% VO2 max.
Exercise at 60% vo2	Exercise at 60% vo2	This arm will receive 15 minutes of exercise at 60% VO2 max.

Primary Outcome Measures

Name	Time	Method
Pressure pain threshold	Post-intervention (approximately 45 minutes after baseline)	Pressure pain threshold measured with an algometer in Kgf

Secondary Outcome Measures

Name	Time	Method
Physical activity	Baseline	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).
Pain intensity	Post-intervention (approximately 45 minutes after baseline)	Assessed using the Visual Analogue Scale from 0 to 100 mm
Fear of movement	Baseline	Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)
Disability	Base	Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)
Anxiety and depression	Baseline	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	Baseline	Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)
Pain phenotype	Baseline	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%).
Aerobic capacity	Baseline	Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.
Symptoms of central sensitization	Baseline	Measured with the Central Sensitization Inventory. Score ranges from 0 to 100 and higher scores indicate higher symptoms of central sensitization.

Trial Locations

Locations (1)

Private Clinics of Physiotherapy; 🇵🇹 Aveiro, Portugal