Changing Trunk Muscle Activation in Patients With Recurrent Low Back Pain in Remission (MAS)

June 10, 2024 updated by: University Ghent

The first aim of the study is to investigate the effects of a single therapy session on trunk muscle activation and lumbopelvic sensorimotor control in persons with recurrent low back pain in remission.

The second aim of the study is to examine the convergent validity of (in)voluntary multifidus activation by means of inspection and palpation during two clinically assessed lumbopelvic sensorimotor control tests in persons with recurrent low back pain in remission. The convergent validity will be examined by calculating the relationship between (1) the clinical score of (in)voluntary multifidus activation, (2) back muscle activation during the same tests measured simultaneously with electromyography and (3) trunk muscle activation during other functional movements measured with electromyography.

The third aim of the study is to investigate the convergent validity of a left-right discrimination test by calculating the relationship between (1) the left-right discrimination test, (2) position-reposition test, (3) the Fremantle Back Awareness Questionnaire and (4) the Photograph Series of Daily Activities Scale.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Low back pain (LBP) is a very common musculoskeletal disorder. Previous research has already demonstrated that trunk muscle function and sensorimotor control (SMC) are altered in people with LBP, which may be an important underlying mechanism contributing to their pain. While there is some evidence regarding the immediate effects of exercise therapy on back muscle function (i.e., earlier onset of activity after one therapy session), the effects of a single therapy session on functional movements and clinically assessed SMC tests in patients with recurrent LBP in remission have never been investigated.

Inspection and palpation are often used in clinical settings to detect lumbopelvic SMC changes in people with LBP. If lumbopelvic SMC changes are noted during the clinical examination, specific SMC therapy can be implemented into the treatment plan. Thus, it is critical that the clinically assessed lumbopelvic SMC tests are sufficiently valid. An important prerequisite is that the clinically assessed SMC parameter is related to objectively measured SMC parameters during the same test. However, clinically assessed lumbopelvic SMC tests are often performed in standardized and less functional positions (e.g., prone lying). As such, the question arises whether results from clinically assessed SMC tests are associated with objective SMC parameters evaluated during functional activities relevant for the individual patient (e.g., lifting). Our systematic review showed that only one clinically assessed lumbopelvic SMC test had sufficient convergent validity with low quality of evidence (Brandt et al., 2024). Moreover, no studies investigated the relationships between clinically assessed lumbopelvic SMC tests and objectively measured SMC parameters during a functional task. Further high-quality studies are therefore needed.

In addition, the left-right discrimination test is also accessible in clinical settings. The left-right discrimination test assesses a person's body perception. During this test, the participant must view images on a computer of a person with the trunk flexed or rotated to the left or right. The participant must indicate as quickly and accurately as possible which side of the trunk of the person in the image is bent or turned. Another way to assess body perception is by using the Fremantle Back Awareness Questionnaire, of which the Dutch version was recently validated. It has been suggested that body perception is the result of the interaction of internal "body maps," sensory information, motor output, and beliefs and perceptions about the body. However, the relationship between the left-right discrimination test, the position-reposition test, and the Fremantle Back Awareness Questionnaire has not yet been explored.

Study Type

Interventional

Enrollment (Estimated)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Belgium
      • Ghent, Belgium, 9000
        • Recruiting
        • Ghent University
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Michiel Brandt, MSc
        • Sub-Investigator:
          • Hannes Meirezonne, MSc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. People between 18-65 years old

  2. Having recurrent non-specific low back pain (LBP) in remission at enrolment:

    • At least 2 episodes of LBP/year, with an 'episode' implying pain lasting a minimum of 24 hours which is preceded and followed by at least 1 month without LBP
    • Minimum LBP intensity during episodes should be ≥2/10 on a numeric rating scale (NRS) from 0 to 10
    • During remission the NRS intensity for LBP should be 0-1/10.
  3. Having a dominant flexion movement pattern/ neutral movement pattern

Exclusion Criteria:

  1. People <18 years old or >65 years old
  2. Having any other type of non-specific LBP (acute, subacute, chronic).
  3. Having an active extension movement pattern
  4. Having any type of blood clotting disorder
  5. People with upper-limb complaints that prevent them from exerting (maximum) force with their arms or hands.
  6. People that received specific sensorimotor control training or fascia-training in the previous year
  7. People with serious underlying conditions (e.g., multiple sclerosis) or severe scoliosis
  8. People with a history of spine surgery
  9. Pregnant women and women who have given birth in the year before enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Specific sensorimotor control training
One low-load treatment session of selective multifidus activation.
Behavioral: Specific sensorimotor control training
Participants allocated to the specific motor control group will receive sensorimotor training of the multifidus muscle.
Active Comparator: Aspecific extension training
One low-load treatment session of back muscle activation.
Behavioral: Aspecific extension training
Participants allocated to the aspecific group will receive spinal extension exercises.
Experimental: Fascia training
One low-load treatment session of general movement exercises.
Behavioral: Fascia training
Participants allocated to the fascia group will receive general movement exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk muscle onset during the rapid arm movement test
Time Frame: Baseline
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
Baseline
Trunk muscle onset during the rapid arm movement test
Time Frame: Immediately after therapy
Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.
Immediately after therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Trunk muscle (co-)activation
Time Frame: Baseline
The participant sits on a stool and holds a horizontal bar with both hands, shoulders at 90 degrees (arms are horizontal). The horizontal bar is secured to the ground using a rope and weights. The participant pushes the horizontal bar upwards without moving the arms, pelvis, or spine. The activation of the back and abdominal muscles will be further investigated.
Baseline
Trunk muscle (co-)activation
Time Frame: Immediately after therapy
The participant sits on a stool and holds a horizontal bar with both hands, shoulders at 90 degrees (arms are horizontal). The horizontal bar is secured to the ground using a rope and weights. The participant pushes the horizontal bar upwards without moving the arms, pelvis, or spine. The activation of the back and abdominal muscles will be further investigated.
Immediately after therapy
Back muscle activation
Time Frame: Baseline
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) bilateral reaching starting in neutral sitting position, and (3) bilateral reaching starting in habitual sitting position.
Baseline
Back muscle activation
Time Frame: Immediately after therapy
Back muscle activation will be analyzed during (1) bilateral reaching in standing position, (2) bilateral reaching starting in neutral sitting position, and (3) bilateral reaching starting in habitual sitting position.
Immediately after therapy
Voluntary multifidus activation
Time Frame: Baseline
Voluntary multifidus activation will be measured while the participant lies prone on a treatment table. The participant will be instructed to gently activate the multifidus muscle without movement of the pelvis or spine, while breathing is maintained.
Baseline
Voluntary multifidus activation
Time Frame: Immediately after therapy
Voluntary multifidus activation will be measured while the participant lies prone on a treatment table. The participant will be instructed to gently activate the multifidus muscle without movement of the pelvis or spine, while breathing is maintained.
Immediately after therapy
Involuntary multifidus activation
Time Frame: Baseline
Involuntary multifidus activation will be assessed by means of the multifidus lift test (Hebert et al., 2015). The participant is lying in the prone position with the shoulders in 120° abduction and 90° flexion at the elbows. The participant will be asked to lift the entire arm approximately 5 cm from the treatment table. The multifidus activation on the contralateral side will be investigated further.
Baseline
Involuntary multifidus activation
Time Frame: Immediately after therapy
Involuntary multifidus activation will be assessed by means of the multifidus lift test (Hebert et al., 2015). The participant is lying in the prone position with the shoulders in 120° abduction and 90° flexion at the elbows. The participant will be asked to lift the entire arm approximately 5 cm from the treatment table. The multifidus activation on the contralateral side will be investigated further.
Immediately after therapy
Lumbar proprioception
Time Frame: Baseline
Lumbar proprioception will be evaluated by means of the position-reposition test. First, the spine of the participant spine is placed in a reference position (50% of maximum range of motion). Second, the participant is asked to return to a neutral sitting position and then to resume the reference position (50% of maximum range of motion). The difference between the two positions will be further investigated.
Baseline
Left-right discrimination test
Time Frame: Baseline
During the left-right discrimination test, the participants are required to view images on a tablet of a person whose trunk is bent or rotated to the left or right. The participant must press 'left' or 'right' as quickly and accurately as possible to indicate which side the person's trunk on the image is bent or rotated. The accuracy and speed will be further analyzed.
Baseline
Disability (questionnaire)
Time Frame: Baseline
The Roland Morris Disability Questionnaire will be used to evaluate disability.
Baseline
Body perception (questionnaire)
Time Frame: Baseline
The Fremantle Back Awareness Questionnaire will be used to evaluate body perception.
Baseline
Kinesiophobia
Time Frame: Baseline
The Tampa Scale for Kinesiophobia will be used to evaluate kinesiophobia.
Baseline
Perceived harmfulness
Time Frame: Baseline
The Photograph Series of Daily Activities will be used to evaluate perceived harmfulness.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Ghent

Collaborators

VZW Educatieve Lichaamsbeweging

Investigators

  • Principal Investigator: Lieven Danneels, Prof, University Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 29, 2024

Primary Completion (Estimated)

October 1, 2025

Study Completion (Estimated)

October 1, 2025

Study Registration Dates

First Submitted

April 11, 2024

First Submitted That Met QC Criteria

June 10, 2024

First Posted (Actual)

June 11, 2024

Study Record Updates

Last Update Posted (Actual)

June 11, 2024

Last Update Submitted That Met QC Criteria

June 10, 2024

Last Verified

June 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ONZ-2022-0310

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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