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

Effects of a Motor Control Exercise Protocol Versus a General Exercise Program in Patients With Nonspecific Chronic Low Back Pain: Ultrasound Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Non-specific lumbar exercise group; Other: motor control lumbar exercises; Other: motor control lumbar exercises with ultrasound echography feedack

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.

• Study Type: Interventional
• Enrollment (Actual): 81
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Madrid
    • Alcalá De Henares, Madrid, Spain, 28805
      • Centro Investigación Fisioterapia y Dolor
    • Alcalá de Henares, Madrid, Spain, 28805
      • Physioterapy and Pain center research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Non-specific lumbar exercise group; Subjects perform a conventional lumbar exercise program twice a week for four weeks.	Other: Non-specific lumbar exercise group; Subjects perform a conventional lumbar exercise program twice a week.
Experimental: Group motor control lumbar exercises; Subjects perform a lumbar stabilization exercise program twice a week for four weeks.	Other: motor control lumbar exercises; Subjects perform a lumbar stabilization exercise program.
Experimental: Group motor control lumbar exercises with ultrasound echography feedack; 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; Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland-Morris Disability Questionnarie	This questionnaire assesses the degree of disability of the patient with low back pain (range 0-24, with 0 being no disability and 24 being total disability). Its Spanish version has been shown to be reliable. To obtain a clinically relevant difference, differences of 1-2 points would be necessary in those patients with low levels of disability, and 7-8 points in those with high levels of disability.	Change from baseline at 3 months
Tampa Scale for Kinesiphobia (TSK-11)	This questionnaire assesses fear of movement. A minimum detectable change in fear or avoidance behaviour requires 5.6 items. The total score of the scale range from 17- 68, where 17 means no kinesiophobia, 68 means severe kinesiophobia, and score ± 37 indicates there is kinesiophobia. This scale has been shown to have an acceptable internal consistency and to be valid.	Change from baseline at 3 months
Patient Global Impression of Change (PGIC)	The self-report measure Patient Global Impression of Change (PGIC) reflects a patient's belief about the efficacy of treatment. PGIC is a 7 point scale depicting a patient's rating of overall improvement. Patients rate their change as "very much improved," "much improved," "minimally improved," "no change," "minimally worse," "much worse," or "very much worse."The PGIC is commonly used in clinical studies assessing pain relief following treatment.	Change from baseline at 3 months

Collaborators and Investigators

• Sponsor: University of Alcala
• Investigators: Study Chair: Daniel Pecos-Martin, PhD, Alcala University

Study record dates

Study Major Dates

• Study Start (Actual): June 20, 2022
• Primary Completion (Actual): October 15, 2023
• Study Completion (Actual): November 15, 2023

Study Registration Dates

• First Submitted: June 13, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 16, 2022

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 14, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Low Back Pain, exercises, ultrasound echography
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CEIM/HU/2019/40

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No