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Clinical Trials/NCT05422079
NCT05422079CompletedNot Applicable

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

University of Alcala4 sites in 1 country81 target enrollmentStarted: June 20, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
81
Locations
4
Primary Endpoint
Numerical Pain Rating Scale

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Participant)

Eligibility Criteria

Ages
18 Years to 70 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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.

Outcomes

Primary Outcomes

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

  • Patient Global Impression of Change (PGIC)(Change from baseline at 3 months)
  • Roland-Morris Disability Questionnarie(Change from baseline at 3 months)
  • Tampa Scale for Kinesiphobia (TSK-11)(Change from baseline at 3 months)

Investigators

Sponsor
University of Alcala
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dr. Daniel Pecos Martín

Physiotherapy and Pain Group member

University of Alcala

Study Sites (4)

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