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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Exercise at 60% vo2; Other: Exercise at 90% vo2

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 Type: Interventional
• Enrollment (Actual): 83
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Aveiro, Portugal
    • Private Clinics of Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: No intervention
Active Comparator: Exercise at 60% vo2; This arm will receive 15 minutes of exercise at 60% VO2 max.	Other: Exercise at 60% vo2; 15 minutes of exercise at 60% VO2 max.
Experimental: Exercise at 90% vo2; This arm will receive 15 minutes of exercise at 90% VO2 max.	Other: Exercise at 90% vo2; 15 minutes of exercise at 90% VO2 max.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Collaborators and Investigators

• Sponsor: Aveiro University

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2021
• Primary Completion (Actual): August 1, 2022
• Study Completion (Actual): February 15, 2023

Study Registration Dates

• First Submitted: October 1, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Estimate): February 20, 2023
• Last Update Submitted That Met QC Criteria: February 17, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CED8_2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No