Motor Control Exercises Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain

NCT05422079 | Completed

• 1 other identifier: CEIM/HU/2019/40
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 2

Brief Summary

The prevalence of low back pain is approximately 49% to 90%, and that 25% of patients seeking treatment for low back pain have a recurrence within the first year. Chronic non-specific low back pain is the most common of all types of pain, not being attributed to a specific pathological cause and with a minimum pain duration of 12 weeks. Forty percent of subjects with acute low back pain will develop chronic low back pain. Exercise is recommended for the treatment of chronic low back pain because of significant improvements in pain and disability over other therapies, but the evidence is low in the treatment of subacute or acute pain, as exercise appears to be equally effective over rest. Motor control is based on the contraction of the deep and stabilising muscles of the lumbar spine (multifidus and transverse abdominis), performing simple voluntary contraction exercises and increasing (without losing this contraction) their difficulty and functionality. At the beginning, the patient must be able to maintain the isometric contraction of the deep muscles while breathing normally. On the other hand, there is great difficulty in voluntarily contracting the multifidus muscles, especially for subjects with chronic non-specific low back pain, where arthrogenic inhibition hinders their contraction. The application of ultrasound as feedback may help patients to correctly contract this musculature. Our main objective in the study will be to measure and compare pain, disability, global impression of effect, in patients with non-specific mechanical chronic low back pain after applying a motor control exercise programme with and without ultrasound feedback. In addition, the investigators will compared this type of exercise with a conventional exercise programme.

Conditions

Low Back Pain

Keywords

Low Back Pain, exercises, ultrasound echography

Outcome Measures

Primary Outcomes (1)

• Numerical Pain Rating Scale

  This scale assesses the level of pain on a range from 0 to 10, with 0 being no pain and 10 being the maximum possible pain. For a clinically relevant difference to exist, there has to be a difference between measurements of at least 2 points. This scale has been shown to have good levels of reliability for pain measurement.

  Change from baseline at 3 months

Secondary Outcomes (3)

• Roland-Morris Disability Questionnarie

  Change from baseline at 3 months

• Tampa Scale for Kinesiphobia (TSK-11)

  Change from baseline at 3 months

• Patient Global Impression of Change (PGIC)

  Change from baseline at 3 months

Study Arms (3)

Non-specific lumbar exercise group

EXPERIMENTAL

Subjects perform a conventional lumbar exercise program twice a week for four weeks.

Other: Non-specific lumbar exercise group

Group motor control lumbar exercises

EXPERIMENTAL

Subjects perform a lumbar stabilization exercise program twice a week for four weeks.

Other: motor control lumbar exercises

Group motor control lumbar exercises with ultrasound echography feedack

EXPERIMENTAL

Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.

Other: motor control lumbar exercises with ultrasound echography feedack

Interventions

Non-specific lumbar exercise group OTHER

Subjects perform a conventional lumbar exercise program twice a week.

Non-specific lumbar exercise group

motor control lumbar exercises OTHER

Subjects perform a lumbar stabilization exercise program.

Group motor control lumbar exercises

motor control lumbar exercises with ultrasound echography feedack OTHER

Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.

Group motor control lumbar exercises with ultrasound echography feedack

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects with low back pain (pain located between the costal margin and the gluteal fold), of non-specific origin, of at least 3 months of evolution.
• Subjects who are not receiving other types of treatment or participating in parallel research.

You may not qualify if:

• Muscular diseases that contraindicate the performance of exercise.
• Tumour and/or bone diseases of the dorsolumbar spine.
• Diagnosis of lumbar radiculopathy.
• Women in the process of pregnancy or breastfeeding.
• Consumption of tobacco, alcohol or other substances.
• BMI \> 30.

Sponsors & Collaborators

• University of Alcala: lead

Study Sites (2)

Centro Investigación Fisioterapia y Dolor

Alcalá de Henares, Madrid, 28805, Spain

Location

Physioterapy and Pain center research

Alcalá de Henares, Madrid, 28805, Spain

Location

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

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

Study Officials

• Daniel Pecos-Martin, PhD

  Alcala University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physiotherapy and Pain Group member

Model Details: Single-blind, randomised clinical trial

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: June 16, 2022
• Study Start: June 20, 2022
• Primary Completion: October 15, 2023
• Study Completion: November 15, 2023
• Last Updated: December 15, 2023

Record last verified: 2023-12

Locations

ES (2)