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

Remission Clinical Trial

— MAS  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06452030
• Other study ID #: ONZ-2022-0310
• Status: Recruiting
• Phase: N/A
• Start date: March 29, 2024
• Est. completion date: October 1, 2025

Study information

• Verified date: June 2024
• Source: University Ghent
• Contact: Lieven Danneels, Prof
• Phone: +32 9 332 26 35
• Email: lieven.danneels[@]ugent.be
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 55
• Est. completion date: October 1, 2025
• Est. primary completion date: October 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Recurrence
• Recurrent Low Back Pain
• Remission

Intervention

Behavioral:
• Specific sensorimotor control training
Participants allocated to the specific motor control group will receive sensorimotor training of the multifidus muscle.
• Aspecific extension training
Participants allocated to the aspecific group will receive spinal extension exercises.
• Fascia training
Participants allocated to the fascia group will receive general movement exercises.

Locations

Country	Name	City	State
Belgium	Ghent University	Ghent

Sponsors (2)

Lead Sponsor	Collaborator
University Ghent	VZW Educatieve Lichaamsbeweging

Country where clinical trial is conducted

Belgium, 

References & Publications (9)

Brandt M, Danneels L, Meirezonne H, Van Oosterwijck J, Willems T, Matheve T. Clinically assessed lumbopelvic sensorimotor control tests in low back pain: are they actually valid? A systematic review according to COSMIN guidelines. Musculoskelet Sci Pract. 2024 Jun;71:102953. doi: 10.1016/j.msksp.2024.102953. Epub 2024 Apr 7. — View Citation

de Vet HC, Heymans MW, Dunn KM, Pope DP, van der Beek AJ, Macfarlane GJ, Bouter LM, Croft PR. Episodes of low back pain: a proposal for uniform definitions to be used in research. Spine (Phila Pa 1976). 2002 Nov 1;27(21):2409-16. doi: 10.1097/01.BRS.0000030307.34002.BE. — View Citation

Hebert JJ, Koppenhaver SL, Teyhen DS, Walker BF, Fritz JM. The evaluation of lumbar multifidus muscle function via palpation: reliability and validity of a new clinical test. Spine J. 2015 Jun 1;15(6):1196-202. doi: 10.1016/j.spinee.2013.08.056. Epub 2013 Oct 4. — View Citation

Hodges PW, Danneels L. Changes in Structure and Function of the Back Muscles in Low Back Pain: Different Time Points, Observations, and Mechanisms. J Orthop Sports Phys Ther. 2019 Jun;49(6):464-476. doi: 10.2519/jospt.2019.8827. — View Citation

Matheve T, Hodges P, Danneels L. The Role of Back Muscle Dysfunctions in Chronic Low Back Pain: State-of-the-Art and Clinical Implications. J Clin Med. 2023 Aug 24;12(17):5510. doi: 10.3390/jcm12175510. — View Citation

Meier R, Iten P, Luomajoki H. Clinical assessments can discriminate altered body perception in patients with unilateral chronic low back pain, but not differences between affected and unaffected side. Musculoskelet Sci Pract. 2019 Feb;39:136-143. doi: 10.1016/j.msksp.2018.12.006. Epub 2018 Dec 21. — View Citation

Stanton TR, Latimer J, Maher CG, Hancock MJ. A modified Delphi approach to standardize low back pain recurrence terminology. Eur Spine J. 2011 May;20(5):744-52. doi: 10.1007/s00586-010-1671-8. Epub 2010 Dec 31. — View Citation

Tsao H, Druitt TR, Schollum TM, Hodges PW. Motor training of the lumbar paraspinal muscles induces immediate changes in motor coordination in patients with recurrent low back pain. J Pain. 2010 Nov;11(11):1120-8. doi: 10.1016/j.jpain.2010.02.004. — View Citation

Tsao H, Hodges PW. Immediate changes in feedforward postural adjustments following voluntary motor training. Exp Brain Res. 2007 Aug;181(4):537-46. doi: 10.1007/s00221-007-0950-z. Epub 2007 May 3. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Trunk muscle onset during the rapid arm movement test	Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.	Baseline
Primary	Trunk muscle onset during the rapid arm movement test	Trunk muscle onset latencies in response to the unilateral rapid arm movement test will be measured by means of electromyography.	Immediately after therapy
Secondary	Trunk muscle (co-)activation	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
Secondary	Trunk muscle (co-)activation	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
Secondary	Back muscle activation	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
Secondary	Back muscle activation	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
Secondary	Voluntary multifidus activation	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
Secondary	Voluntary multifidus activation	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
Secondary	Involuntary multifidus activation	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
Secondary	Involuntary multifidus activation	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
Secondary	Lumbar proprioception	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
Secondary	Left-right discrimination test	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
Secondary	Disability (questionnaire)	The Roland Morris Disability Questionnaire will be used to evaluate disability.	Baseline
Secondary	Body perception (questionnaire)	The Fremantle Back Awareness Questionnaire will be used to evaluate body perception.	Baseline
Secondary	Kinesiophobia	The Tampa Scale for Kinesiophobia will be used to evaluate kinesiophobia.	Baseline
Secondary	Perceived harmfulness	The Photograph Series of Daily Activities will be used to evaluate perceived harmfulness.	Baseline