Clinical trial NCT02304120: Sensorimotor Training in Low-back Pain Rehabilitation
Official title: Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: proprioception
postural control
sensorimotor training
uncontrolled manifold
Lead sponsor: Reha Rheinfelden
Sponsor class: OTHER
Collaborators: name: University of Zurich
First posted: 2014-12-01
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of additional sensorimotor training (proprioceptive postural training, PPT) to conventional therapy in the treatment of chronic low-back pain. Half of the participants will receive instructed treadmill training as an active comparator against PPT. All participants receive conventional physiotherapy as prescribed by their treating medical doctors. It is expected that the PPT group will improve in postural control, proprioceptive, as well as pain and function outcomes to a significantly greater extent than the active control group.


Eligibility criteria: Inclusion Criteria:

* Patients with musculoskeletal low back pain (non-specific low back pain)
* Age ≥ 18 years

Exclusion Criteria:

* Known or suspected neurological diseases or lesions
* Traumatic injury of musculoskeletal system (fractures, tumours)
* Spinal pathologies (e.g., tumour, infection, fracture, and inflammatory disease)
* Previous spinal surgery
* Presence of any contraindication to exercise (fracture or cardiovascular limitations)

Primary outcomes:
measure: Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
timeFrame: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
measure: Change of functional status recorded with the Oswestry Disability Index (ODI)
timeFrame: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Secondary outcomes:
measure: Centre of Pressure
timeFrame: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
measure: Joint Repositioning Error (segmental)
timeFrame: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
measure: Uncontrolled Manifold Index (UCM)
timeFrame: Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Other outcomes:
Locations:
city: Rheinfelden
country: Switzerland
facility: Reha Rheinfelden
state: Aargau
Study officials:
affiliation: Reha Rheinfelden
name: Michael A McCaskey, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: ETH Zurich
name: Eling D. de Bruin, PD PhD
role: STUDY_CHAIR
affiliation: Reha Rheinfelden
name: Corina Schuster-Amft, PT PhD
role: STUDY_CHAIR
References:
citation: Scholz JP, Schoner G. The uncontrolled manifold concept: identifying control variables for a functional task. Exp Brain Res. 1999 Jun;126(3):289-306. doi: 10.1007/s002210050738.
citation: McCaskey MA, Wirth B, Schuster-Amft C, de Bruin ED. Postural sensorimotor training versus sham exercise in physiotherapy of patients with chronic non-specific low back pain: An exploratory randomised controlled trial. PLoS One. 2018 Mar 9;13(3):e0193358. doi: 10.1371/journal.pone.0193358. eCollection 2018.
citation: McCaskey MA, Schuster-Amft C, Wirth B, de Bruin ED. Effects of postural specific sensorimotor training in patients with chronic low back pain: study protocol for randomised controlled trial. Trials. 2015 Dec 15;16:571. doi: 10.1186/s13063-015-1104-4.