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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05077566
• Other study ID #: CED8_2021
• Status: Completed
• Phase: N/A
• Start date: October 3, 2021
• Est. completion date: February 15, 2023

Study information

• Verified date: February 2023
• Source: Aveiro University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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, anxiety and depression interfere with the immediate hypoalgesic effect of exercise.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 83
• Est. completion date: February 15, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Exercise at 60% vo2
15 minutes of exercise at 60% VO2 max.
• Exercise at 90% vo2
15 minutes of exercise at 90% VO2 max.

Locations

Country	Name	City	State
Portugal	Private Clinics of Physiotherapy	Aveiro

Sponsors (1)

Lead Sponsor	Collaborator
Aveiro University

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pressure pain threshold	Pressure pain threshold measured with an algometer in Kgf	Baseline
Primary	Pressure pain threshold	Pressure pain threshold measured with an algometer in Kgf	Post-intervention (approximately 45 minutes after baseline)
Secondary	Aerobic capacity	Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.	Baseline
Secondary	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).	Baseline
Secondary	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.	Baseline
Secondary	Catastrophizing	Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)	Baseline
Secondary	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)	Baseline
Secondary	Disability	Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)	Base
Secondary	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%).	Baseline
Secondary	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.	Baseline
Secondary	Pain intensity	Assessed using the Visual Analogue Scale from 0 to 100 mm	Baseline
Secondary	Pain intensity	Assessed using the Visual Analogue Scale from 0 to 100 mm	Post-intervention (approximately 45 minutes after baseline)