Effects of Different Kinds of Exercise in Low Back Pain

NCT06330961 | Completed

• 1 other identifier: 2023-MED-2756299
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

Brief Summary

Low back pain is considered one of the great global challenges in public health due to its high prevalence. Exercise have been shown to cause an increase in pain thresholds, through the effect known as exercise-induced hypoalgesia. Little is known about exercise-induced hypoalgesia induced by different modalities of exercise in low back pain, and its possible effects in lumbopelvic biomechanics. The goal of this clinical trial is to compare the effect of exercise-induced hypoalgesia after an isometric, aerobic and a sham/ placebo exercise in non-specific low back pain. The main questions it aims to answer are:

• Does an isometric exercise intervention cause exercise-induced hypoalgesia in non-specific low back pain patients?
• Is the effect of an isometric exercise intervention comparable to that of aerobic exercise?
• Is a placebo/ sham intervention also effective to reduce pain thresholds in these patients?
• Do healthy subjects show the same effects in pain thresholds as low back pain patients ? Participants will perform an isometric, aerobic and placebo/ sham exercise intervention in three different recording sessions. Before and after the interventions, pain intensity, pain-pressure thresholds and lumbopelvic biomechanical parameters during trunk flexion-extension will be recorded. Researchers will compare a group of low back pain patients to an age-, gender- and anthropometrics-matched control group of pain-free subjects to see if exercise-induced hypoalgesia is also observed when there is no low back pain diagnosis.

Conditions

Low Back Pain

Keywords

low back pain; isometric exercise; pain threshold; back muscles; surface electromyography

Outcome Measures

Primary Outcomes (9)

• Pain intensity

  Pain intensity will be tested using a visual analogue scale, scored from 0 to 10.

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Pain-pressure thresholds

  Pain-pressure thresholds will be measured with an algometer on 3 points in a randomized order: 1) thenar eminence; 2) erector spinae (5 cm distal to L3); 3) the center of the long head of biceps femoris. Unit: kg/cm2

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Trunk flexion-extension electromyography (EMG)

  Average percentages of lumbopelvic muscles activation during flexion, extension, eccentric and concentric contractions and the myoelectrical silence, recorded by an EMG100C Biopac module (Biopac Systems, Inc., Goleta, CA). Unit: percentages of maximum muscle activation

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Flexion-extension ratio (EMG)

  A ratio between the average lumbopelvic muscles activity at trunk flexion and its average activity at extension, to quantify the relaxation level of the muscle. Unit: dimensionless

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Maximum ranges of lumbar and pelvic flexion

  Maximum ranges of lumbar and pelvic flexion, in degrees, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: degrees

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Trunk flexion-extension percentages of motion

  Average percentages of maximum lumbar and pelvic flexion during flexion and extension, and at the start and end of lumbopelvic muscles relaxation, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA) and expressed as a percentage of the maximum range of flexion during each flexion-extension cycle. Unit: percentages of maximum flexion

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Time of maximum flexion

  Percentage of total flexion-extension time during which the lumbar spine and the pelvis are flexed over 90% of their maximum flexion, measured with a Liberty 240/16 electrogoniometer (Polhemus Inc., Colchester, USA). Unit: percentage of total flexion-extension time

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Fear-avoidance beliefs

  Fear-avoidance beliefs will be tested using a validated version of the Fear-Avoidance Beliefs Questionnaire (FABQ).

  Day 1, before, after and 30 minutes past the first intervention. Day 8, before, after and 30 minutes past the second intervention. Day 15, before, after and 30 minutes past the third intervention.

• Pain distribution and supra-threshold stimulation

  Area of pain irradiation, and area of distribution of pressure-induced referred pain after a supra-threshold stimulation over the infraspinatus muscle. Depicted by the participants on a body chart. Unit: cm2

  Day 1, before and after the first intervention. Day 8, before and after the second intervention. Day 15, before and after the third intervention.

Secondary Outcomes (5)

• Anthropometric data: height

  Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.

• Anthropometric data: weight

  Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.

• Date of birth/ age

  Day 1, before the first intervention.

• Sex/ gender

  Day 1, before the first intervention.

• Basic clinical history and occupational data

  Day 1, before the first intervention.

Study Arms (2)

Pain-free participants

EXPERIMENTAL

Aerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of subjects with no past history of low back pain. They will serve as a control group.

Other: Isometric exercise; Other: Aerobic exercise; Other: Placebo intervention

Low back pain patients

EXPERIMENTAL

Aerobic exercise, Biering-Sorensen test and placebo interventions will be administered to a group of non-specific low back pain patients. They will serve as the primary intervention group.

Other: Isometric exercise; Other: Aerobic exercise; Other: Placebo intervention

Interventions

Isometric exercise OTHER

Biering-Sorensen maneuver.Participants will be in a prone position with the anterosuperior iliac spines on the edge of a stretcher. Their lower body will be strapped by the ankles and hips, with the upper body suspended. Participants will keep their trunk extended and parallel to the ground for 60 seconds.

Low back pain patients; Pain-free participants

Aerobic exercise OTHER

After adjusting height, pedals and backrest in a cycloergometer, there will be 20 minutes of cycling, of which 5 minutes will be a warm-up at 50-60% of maximum heart rate and 15 minutes at 60-70% of maximum heart rate. There will be a constant monitoring of heart rate and oxygen saturation.

Low back pain patients; Pain-free participants

Placebo intervention OTHER

A maneuver equivalent to Biering-Sorensen test, but with upper limb support on a level step and electromyographic monitoring to ensure minimal activation of the erector spinae. It will be explained to the participant that the aim of such an intervention is to cause electromyographic silence of the erector spinae and keep it for 1 minute.

Low back pain patients; Pain-free participants

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Control group: no prior history of low back pain or any other kind of low back disorders.
• Low back pain group:
• current symptoms of non-specific low back pain
• Symptoms must be severe enough to have caused recent loss of work days.

You may not qualify if:

• mental or cognitive impairment influencing the ability to understand and execute oral or written instructions
• any sign or symptom suggestive of potential underlying diseases
• presence of red flags or high-risk criteria for referral to emergency medical services
• severe functional limitation due to the intensity of the pain
• high irritability of symptoms at the time of the selection process
• inability to tolerate the prone position

Sponsors & Collaborators

• University of Valencia: lead

Study Sites (1)

Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València

Valencia, Valencia, 46010, Spain

Location

MeSH Terms

Conditions

Low Back Pain

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Daniel Sánchez-Zuriaga, PhD, MD

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2024
• First Posted: March 26, 2024
• Study Start: January 8, 2024
• Primary Completion: May 13, 2025
• Study Completion: May 13, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)