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

NCT ID: NCT05077566

Last Updated: 2023-02-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-03

Study Completion Date

2023-02-15

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Low Back Pain

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise at 60% vo2

This arm will receive 15 minutes of exercise at 60% VO2 max.

Group Type ACTIVE_COMPARATOR

Exercise at 60% vo2

Intervention Type OTHER

15 minutes of exercise at 60% VO2 max.

Exercise at 90% vo2

This arm will receive 15 minutes of exercise at 90% VO2 max.

Group Type EXPERIMENTAL

Exercise at 90% vo2

Intervention Type OTHER

15 minutes of exercise at 90% VO2 max.

No intervention

No intervention

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise at 60% vo2

15 minutes of exercise at 60% VO2 max.

Intervention Type OTHER

Exercise at 90% vo2

15 minutes of exercise at 90% VO2 max.

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Aveiro University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Anabela G Silva

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Private Clinics of Physiotherapy

Aveiro, , Portugal

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Portugal

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CED8_2021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exercise and Low Back Pain
NCT02029131 COMPLETED NA
Spinal Kinematics Variability
NCT03507296 COMPLETED