Effects of Different Kinds of Exercise in Low Back Pain

Low Back Pain Clinical Trial

Official title:

Effects of Different Kinds of Exercises in Pain, Lumbopelvic Biomechanics and Pain Pressure Thresholds in Patients With Non-specific Low Back Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06330961
• Other study ID #: 2023-MED-2756299
• Status: Recruiting
• Phase: N/A
• Start date: January 8, 2024
• Est. completion date: February 2025

Study information

• Verified date: March 2024
• Source: University of Valencia
• Contact: Daniel Sánchez-Zuriaga, PhD, MD
• Phone: +34963983522
• Email: daniel.sanchez[@]uv.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Exercise causes an immediate reduction in pain sensitivity, known as exercise-induced hypoalgesia. This phenomenon is described as the immediate and lasting reduction of pain sensitivity after therapeutic exercise. This effect has been observed after isometric muscle contractions and aerobic exercises in healthy subjects.

The hypoalgesic response is often shown as an increase in pain-pressure thresholds in regions close to the most active muscle groups during exercise, and also in regions further away, which probably reflects the activation of systemic endogenous pain inhibitory systems. This effect has also been studied in patients with chronic pain.

Although there is previous work that has shown that aerobic exercise and isometric exercise can cause exercise-induced hypoalgesia, there is no evidence on exercise-induced hypoalgesia caused by isometric maneuvers in patients with low back pain. There is also a lack of placebo-controlled studies, or even studies comparing the analgesic effect of isometric and aerobic exercise in this population.

Therefore, the aim of this study will be to investigate, in a placebo-controlled intervention, whether various exercise modalities (isometric, aerobic) that involve activation of the lumbopelvic muscles result in local hypoalgesia in the area of the most active muscles, and/or hypoalgesia in more distant areas of the body, in subjects with low back pain and a group of healthy subjects which will serve as a control group.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 76
• Est. completion date: February 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Isometric exercise
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.
• Aerobic exercise
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.
• Placebo intervention
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.

Locations

Country	Name	City	State
Spain	Clinical Anatomy of the Musculoskeletal System Laboratory. Department of Anatomy and Human Embryology, School of Medicine, Universitat de València	Valencia

Sponsors (1)

Lead Sponsor	Collaborator
University of Valencia

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	Anthropometric data: height	Measured with a stadiometer, barefoot. Unit: meters	Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Secondary	Anthropometric data: weight	Measured with a calibrated scale with the participant barefoot and wearing light clothes. Unit: kilograms	Day 1, before the first intervention. Day 8, before the second intervention. Day 15, before the third intervention.
Secondary	Date of birth/ age	Self-reported. Unit: years	Day 1, before the first intervention.
Secondary	Sex/ gender	Self-reported	Day 1, before the first intervention.
Secondary	Basic clinical history and occupational data	Self-reported, in an interview. Antecedents of low back pain, occupation	Day 1, before the first intervention.