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NCT Number: NCT05422079

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

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.

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Key information

Conditions

Low Back Pain Back Pain Behavior Motor Activity Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centro Investigación Fisioterapia y Dolor, Alcalá de Henares, Madrid, Spain

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Non-specific lumbar exercise group

Other

Subjects perform a conventional lumbar exercise program twice a week.

motor control lumbar exercises

Other

Subjects perform a lumbar stabilization exercise program.

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.

Primary outcomes

  1. Numerical Pain Rating Scale

    Time frame: Change from baseline at 3 months

    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.

Secondary outcomes

  1. Roland-Morris Disability Questionnarie

    Time frame: Change from baseline at 3 months

    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.

  2. Tampa Scale for Kinesiphobia (TSK-11)

    Time frame: Change from baseline at 3 months

    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.

  3. Patient Global Impression of Change (PGIC)

    Time frame: Change from baseline at 3 months

    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.

Sponsors and collaborators

Lead sponsor

University of Alcala

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jun 16, 2022
Registry last updated
Dec 15, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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