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

Primary Purpose

Low Back Pain

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Non-specific lumbar exercise group
motor control lumbar exercises
motor control lumbar exercises with ultrasound echography feedack
Sponsored by
University of Alcala
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Low Back Pain, exercises, ultrasound echography

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Centro Investigación Fisioterapia y DolorRecruiting
  • Physioterapy and Pain center researchRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Non-specific lumbar exercise group

Group motor control lumbar exercises

Group motor control lumbar exercises with ultrasound echography feedack

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.

Full Information

First Posted
June 13, 2022
Last Updated
October 24, 2023
Sponsor
University of Alcala
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1. Study Identification

Unique Protocol Identification Number
NCT05422079
Brief Title
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

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2022 (Actual)
Primary Completion Date
October 15, 2023 (Actual)
Study Completion Date
October 15, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alcala

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Low Back Pain, exercises, ultrasound echography

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Single-blind, randomised clinical trial
Masking
Participant
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-specific lumbar exercise group
Arm Type
Experimental
Arm Description
Subjects perform a conventional lumbar exercise program twice a week for four weeks.
Arm Title
Group motor control lumbar exercises
Arm Type
Experimental
Arm Description
Subjects perform a lumbar stabilization exercise program twice a week for four weeks.
Arm Title
Group motor control lumbar exercises with ultrasound echography feedack
Arm Type
Experimental
Arm Description
Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.
Intervention Type
Other
Intervention Name(s)
Non-specific lumbar exercise group
Intervention Description
Subjects perform a conventional lumbar exercise program twice a week.
Intervention Type
Other
Intervention Name(s)
motor control lumbar exercises
Intervention Description
Subjects perform a lumbar stabilization exercise program.
Intervention Type
Other
Intervention Name(s)
motor control lumbar exercises with ultrasound echography feedack
Intervention Description
Subjects perform a lumbar stabilization exercise program in conjunction with a video where participants can see how the muscles contract.
Primary Outcome Measure Information:
Title
Numerical Pain Rating Scale
Description
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.
Time Frame
Change from baseline at 3 months
Secondary Outcome Measure Information:
Title
Roland-Morris Disability Questionnarie
Description
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.
Time Frame
Change from baseline at 3 months
Title
Tampa Scale for Kinesiphobia (TSK-11)
Description
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.
Time Frame
Change from baseline at 3 months
Title
Patient Global Impression of Change (PGIC)
Description
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.
Time Frame
Change from baseline at 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patricia M Merinero, PhD
Phone
661637862
Email
patricia.m.merinero@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Pecos-Martin, PhD
Organizational Affiliation
Alcala University
Official's Role
Study Chair
Facility Information:
Facility Name
Centro Investigación Fisioterapia y Dolor
City
Alcalá De Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Martinez-Merinero, PhD
Phone
683378391
Email
info@institutofisioterapiaydolor.es
First Name & Middle Initial & Last Name & Degree
Laura Cabellos
Phone
683378391
Email
l.cabellos@uah.es
Facility Name
Physioterapy and Pain center research
City
Alcalá de Henares
State/Province
Madrid
ZIP/Postal Code
28805
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura López Pérez, Mrs
Phone
+34683378391
Email
info@institutofisioterapiaydolor.es

12. IPD Sharing Statement

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

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