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Completed

NCT Number: NCT05077566

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private Clinics of Physiotherapy

Aveiro, Portugal

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Exercise at 60% vo2

Other

15 minutes of exercise at 60% VO2 max.

Exercise at 90% vo2

Other

15 minutes of exercise at 90% VO2 max.

Primary outcomes

  1. Pressure pain threshold

    Time frame: Baseline

    Pressure pain threshold measured with an algometer in Kgf

  2. Pressure pain threshold

    Time frame: Post-intervention (approximately 45 minutes after baseline)

    Pressure pain threshold measured with an algometer in Kgf

Secondary outcomes

  1. Aerobic capacity

    Time frame: Baseline

    Measured with the Chester Step Test (CST) which gives aerobic capacity and allows the calculation of percentage of VO2 max.

  2. Physical activity

    Time frame: 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).

  3. Anxiety and depression

    Time frame: 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.

  4. Catastrophizing

    Time frame: Baseline

    Measured with the Catastrophizing Scale (range 0-52 and higher values are indicative of higher pain catastrophizing)

  5. Fear of movement

    Time frame: Baseline

    Measured with the TAMPA Scale of Kinesiophobia (range: 13-52 and higher values are indicative of higher levels of fear of movement)

  6. Disability

    Time frame: Base

    Measured with the Roland Morris Disability Questionnaire (range: 0 to 24, with higher values indicating higher disability)

  7. Pain phenotype

    Time frame: 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%).

  8. Symptoms of central sensitization

    Time frame: Baseline

    Measured with the Central Sensitization Inventory. Score ranges from 0 to 100 and higher scores indicate higher symptoms of central sensitization.

  9. Pain intensity

    Time frame: Baseline

    Assessed using the Visual Analogue Scale from 0 to 100 mm

  10. Pain intensity

    Time frame: Post-intervention (approximately 45 minutes after baseline)

    Assessed using the Visual Analogue Scale from 0 to 100 mm

Sponsors and collaborators

Lead sponsor

Aveiro University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
Oct 14, 2021
Registry last updated
Feb 21, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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