Clinical trial NCT05422079: Motor Control Exercises Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain
Official title: Effects of a Motor Control Exercise Protocol Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain: Ultrasound Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain, exercises, ultrasound echography
Lead sponsor: University of Alcala
Sponsor class: OTHER
First posted: 2022-06-16
Enrollment: 81
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind, randomised clinical trial
Primary purpose: TREATMENT

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.

Detailed description: A study will be carried out to compare a conventional exercise protocol for the management of non-specific chronic low back pain, with another motor control exercise protocol with and without ultrasound feedback for its correct learning and execution.

For the ultrasound feedback, a video will be recorded where the participant will be able to see how the core muscles contract when each of the motor control exercises is performed.

The participants will be divided into three groups. The first group will perform a general exercise plan for the lower back. The second group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles, and the third group will perform a plan of specific motor control exercises aimed at activating the lumbar multifidus and transversus abdominis muscles using ultrasound as a feedback method.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Numerical Pain Rating Scale
timeFrame: Change from baseline at 3 months
Secondary outcomes:
measure: Roland-Morris Disability Questionnarie
timeFrame: Change from baseline at 3 months
measure: Tampa Scale for Kinesiphobia (TSK-11)
timeFrame: Change from baseline at 3 months
measure: Patient Global Impression of Change (PGIC)
timeFrame: Change from baseline at 3 months
Other outcomes:
Locations:
city: Alcalá De Henares
country: Spain
facility: Centro Investigación Fisioterapia y Dolor
state: Madrid
city: Alcalá de Henares
country: Spain
facility: Physioterapy and Pain center research
state: Madrid
Study officials:
affiliation: Alcala University
name: Daniel Pecos-Martin, PhD
role: STUDY_CHAIR
References: