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

Sponsor
Aveiro University (Other)
Overall Status
Recruiting
CT.gov ID
NCT05077566
Collaborator
(none)
90
1
3
11.9
7.5

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Exercise at 60% vo2
  • Other: Exercise at 90% vo2
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Immediate Exercise-Induced Hypoalgesia in Patients With Chronic Low Back Pain
Actual Study Start Date :
Oct 3, 2021
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Oct 1, 2022

Arms and Interventions

Arm Intervention/Treatment
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.

No Intervention: No intervention

No intervention

Outcome Measures

Primary Outcome Measures

  1. Pressure pain threshold [Baseline]

    Pressure pain threshold measured with an algometer in Kgf

  2. Pressure pain threshold [Post-intervention (approximately 45 minutes after baseline)]

    Pressure pain threshold measured with an algometer in Kgf

Secondary Outcome Measures

  1. Aerobic capacity [Baseline]

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

  2. 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).

  3. 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.

  4. Catastrophizing [Baseline]

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

  5. 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)

  6. Disability [Base]

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

  7. 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%).

  8. 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.

  9. Pain intensity [Baseline]

    Assessed using the Visual Analogue Scale from 0 to 100 mm

  10. Pain intensity [Post-intervention (approximately 45 minutes after baseline)]

    Assessed using the Visual Analogue Scale from 0 to 100 mm

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Private Clinics of Physiotherapy Aveiro Portugal

Sponsors and Collaborators

  • Aveiro University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Anabela G Silva, Assistant Professor, Aveiro University
ClinicalTrials.gov Identifier:
NCT05077566
Other Study ID Numbers:
  • CED8_2021
First Posted:
Oct 14, 2021
Last Update Posted:
Jul 15, 2022
Last Verified:
Oct 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 15, 2022