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

NCT06452030 | Recruiting

• 1 other identifier: ONZ-2022-0310
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Recurrent Low Back Pain; Remission

Keywords

Low back pain; Motor control; Exercise; Randomised Controlled Trial

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (14)

• Trunk muscle (co-)activation

  Baseline

• Trunk muscle (co-)activation

  Immediately after therapy

• Back muscle activation

  Baseline

• Back muscle activation

  Immediately after therapy

• Voluntary multifidus activation

  Baseline

Study Arms (3)

Specific sensorimotor control training

EXPERIMENTAL

One low-load treatment session of selective multifidus activation.

Behavioral: Specific sensorimotor control training

Aspecific extension training

ACTIVE COMPARATOR

One low-load treatment session of back muscle activation.

Behavioral: Aspecific extension training

Fascia training

EXPERIMENTAL

One low-load treatment session of general movement exercises.

Behavioral: Fascia training

Interventions

Specific sensorimotor control training BEHAVIORAL

Participants allocated to the specific motor control group will receive sensorimotor training of the multifidus muscle.

Specific sensorimotor control training

Aspecific extension training BEHAVIORAL

Participants allocated to the aspecific group will receive spinal extension exercises.

Aspecific extension training

Fascia training BEHAVIORAL

Participants allocated to the fascia group will receive general movement exercises.

Fascia training

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• People between 18-65 years old
• 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.
• Having a dominant flexion movement pattern/ neutral movement pattern

You may not qualify if:

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

Sponsors & Collaborators

• University Ghent: lead
• VZW Educatieve Lichaamsbeweging: collaborator

Study Sites (1)

Ghent University

Ghent, 9000, Belgium

RECRUITING

Related Publications (9)

• 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.

  PMID: 12438991 BACKGROUND

• 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.

  PMID: 21193932 BACKGROUND

• 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.

  PMID: 17476489 BACKGROUND

• 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.

  PMID: 20434958 BACKGROUND

• 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.

  PMID: 37685576 BACKGROUND

• 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.

  PMID: 31151377 BACKGROUND

• 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.

  PMID: 24314767 BACKGROUND

• 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.

  PMID: 30593940 BACKGROUND

• 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.

  PMID: 38604022 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Officials

• Lieven Danneels, Prof

  University Ghent

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lieven Danneels, Prof

CONTACT

+32 9 332 26 35; lieven.danneels@ugent.be

Thomas Matheve, Prof

CONTACT

thomas.matheve@ugent.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The study model is parallel. Participants with recurrent low back pain in remission will be randomly allocated to receive either (1) specific sensorimotor control training, (2) general extension training or (3) fascia therapy (i.e. parallel study model).

Study Record Dates

• First Submitted: April 11, 2024
• First Posted: June 11, 2024
• Study Start: March 29, 2024
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: June 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)