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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-60
SponsorHasselt University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

Disqualifiers

Pregnancy

Previous trauma or surgery to the spine, pelvis or lower limbs

Structural spinal deformity (e.g., scoliosis)

Neurological, neuromuscular, respiratory or systemic disease

Trial population

Flemish Brabant

Trial design

Design model

Other

Time perspective

Other

Treatments tested in this trial

  • Proprioceptive training

    Other intervention

    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.

Treatment groups

100 Participants
are divided into 2 treatment groups
Group A: Patients with non-specific low back pain1 intervention
Group B: Healthy controls0 interventions

Trial outcomes

Primary outcomes

1

Proprioceptive postural control at baseline 1 (t= 0 weeks)

Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

Time frame
At baseline 1 (t= 0 weeks)
2

Proprioceptive postural control at baseline 2 (t= 8 weeks) (only for patients)

Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

Time frame
At baseline 2 (t= 8 weeks)
3

Proprioceptive postural control after 8 weeks of training (t= 16 weeks) (only for patients)

Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

Time frame
After 8 weeks of training (t= 16 weeks)
4

Proprioceptive postural control after 16 weeks of training (t= 24 weeks) (only for patients)

Center-of-pressure displacement in response to ankle and/or back muscle vibration and the Relative Proprioceptive Weighting ratio will be calculated.

Time frame
After 16 weeks of training (t= 24 weeks)

Secondary outcomes

1

Disability due to low back pain

Participants will be asked to complete the Modified Low Back Pain Disability Questionnaire.

Time frame
Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
2

Risk for future work disability due to low back pain

Participants will be asked to complete the short version of the Örebro Musculoskeletal Pain Screening Questionnaire

Time frame
Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
3

Pain-related fear of movement

Participants will be asked to complete the Tampa Scale for Kinesiophobia.

Time frame
Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)
4

Fear-avoidance beliefs about physical activity and work

Participants will be asked to complete the Fear-Avoidance Beliefs Questionnaire.

Time frame
Controls: once, immediately after inclusion, Patients: 5 times, immediately after inclusion (t= 0w), after 8 weeks (t= 8w, 2nd baseline), after 8 weeks of training (t= 16w), after 16 weeks of training (t= 24w), 16 weeks after the end of training (t= 40w)

Other outcomes

1

Age

Age (years) will be recorded.

Time frame
Immediately after inclusion
2

Sex (male/female)

Sex will be recorded.

Time frame
Immediately after inclusion
3

Highest level of education

Highest level of education will be recorded.

Time frame
Immediately after inclusion
4

Current employment status

Current employment status will be recorded.

Time frame
Immediately after inclusion

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hasselt University

Lead sponsor

KU Leuven

Collaborator