The Forgotten Role of Back Muscle Characteristics to Tailor Exercise Therapy for Recurrent Non-specific Low Back Pain

NCT ID: NCT05851196

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-15

Study Completion Date

2027-12-31

Brief Summary

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Patients with non-specific low back pain will be compared to healthy, age- and sex-matched controls to determine the most discriminating back muscle characteristics and to delineate possible phenotypes of patients with non-specific low back pain showing impaired proprioceptive postural control. Additionally, the group of patients with non-specific low back pain will receive a 16-week, high-load proprioceptive training program. The effects of this training program on the different back muscle characteristics and proprioceptive postural control will be evaluated.

Detailed Description

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The Back-to-Back study consists of a cross-sectional study and a proof-of-concept study. The cross-sectional study aims to gain more insight into the peripheral underlying mechanisms of impaired proprioceptive postural control in patients with non-specific low back pain. Macroscopic, microscopic, hemodynamic, and electrophysiological characteristics of the lumbar multifidus and erector spinae muscles will be compared between patients with non-specific low back pain and healthy, age- and sex-matched controls. The interrelatedness between these back muscle characteristics and the correlation with proprioceptive postural control will be examined. The most discriminating muscle characteristics will be determined based upon which phenotypes of patients with non-specific low back pain will be delineated. The proof-of-concept study aims to assess the effects of high-load proprioceptive training on back muscle characteristics and proprioceptive postural control in patients with non-specific low back pain.

Conditions

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Low Back Pain Back Pain Lower Back Chronic

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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Patients with non-specific low back pain

Individuals with chronic non-specific ow back pain

Proprioceptive training

Intervention Type OTHER

A physiotherapist tailors the exercises to the patient's functional demands and pain- or fear-inducing activities. Guided by the therapist, patients look for ways to integrate the exercises into their daily life activities. Each week, patients receive feedback from the physiotherapist, and the training program is gradually progressed. The patients are instructed to perform the exercises daily, integrated into their daily activities, hobbies, and work. The program contains: (1) exercises to improve the sense of posture and movement, (2) exercises to correct the reference frame from which patients control posture and movement, (3) muscle control exercises, (4) exercises to increase variability in postures and movement patterns, (5) functionality: patients search for ways to correct and integrate alternative postures and movement patterns into their daily life, (6) high training frequency and high load, (7) focus on sensing, localizing and differentiating, rather than movement control.

Healthy controls

Healthy, age- and sex-matched individuals without low back pain

No interventions assigned to this group

Interventions

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Proprioceptive training

A physiotherapist tailors the exercises to the patient's functional demands and pain- or fear-inducing activities. Guided by the therapist, patients look for ways to integrate the exercises into their daily life activities. Each week, patients receive feedback from the physiotherapist, and the training program is gradually progressed. The patients are instructed to perform the exercises daily, integrated into their daily activities, hobbies, and work. The program contains: (1) exercises to improve the sense of posture and movement, (2) exercises to correct the reference frame from which patients control posture and movement, (3) muscle control exercises, (4) exercises to increase variability in postures and movement patterns, (5) functionality: patients search for ways to correct and integrate alternative postures and movement patterns into their daily life, (6) high training frequency and high load, (7) focus on sensing, localizing and differentiating, rather than movement control.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Patients with non-specific low back pain:

* Aged 18-60 years
* Non-specific low back pain without radicular leg pain
* Mechanical low back pain with episodes of \<4 on the numerical pain rating scale and episodes of \>6 on the numerical pain rating scale
* Non-specific low back pain for three months or more
* Score of 20% or more on the Modified Low Back Pain Disability Questionnaire
* Informed consent to participate

Healthy controls:

* Aged 18-60 years
* No history of low back pain needing medical treatment or resulting in a limited activity level
* No low back pain in the previous six months
* Informed consent to participate

Exclusion Criteria

* Pregnancy
* Previous trauma or surgery to the spine, pelvis or lower limbs
* Structural spinal deformity (e.g., scoliosis)
* Neurological, neuromuscular, respiratory or systemic disease
* Central sensitization: score of 50/100 or more on the Central Sensitization Inventory
* Specific vestibular or balance problems
* Acute lower limb or neck problems
* Body mass index of 30 kg/m² or more
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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KU Leuven

OTHER

Sponsor Role collaborator

Hasselt University

OTHER

Sponsor Role lead

Responsible Party

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Lotte Janssens

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Lotte Janssens, PhD

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

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REVAL Rehabilitation Research Center, Hasselt University

Diepenbeek, , Belgium

Site Status RECRUITING

Department of Rehabilitation Sciences, KU Leuven

Leuven, , Belgium

Site Status RECRUITING

Countries

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Belgium

Central Contacts

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Lotte Janssens, PhD

Role: CONTACT

+3211292174

Simon Brumagne, PhD

Role: CONTACT

Facility Contacts

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Lotte Janssens, PhD

Role: primary

Nina Goossens, PhD

Role: backup

Simon Brumagne, PhD

Role: primary

Vasiliki Karagiannopoulou, MSc

Role: backup

Other Identifiers

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S67192

Identifier Type: -

Identifier Source: org_study_id

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