Sensorimotor Training in Low-back Pain Rehabilitation (SeMoPoP)

Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Other: Proprioceptive postural training; Other: Conventional physiotherapy; Other: Treadmill training

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Aargau
    • Rheinfelden, Aargau, Switzerland, 4310
      • Reha Rheinfelden

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sensorimotor; The experimental group will receive added PPT to the conventional physiotherapy. PPT will be applied by means of a neuro-orthopaedic medical device ("Posturomed®", see section 3.2). The "Posturomed" allows adaptive oscillation in the horizontal plane. Therapy instructions advise seven stages of difficulty. In all stages the patient is asked to provoke oscillation by stepping on site. After three steps, the patient must stand still on one leg for 2 seconds before he or she repeats the steps. Difficulty is increased by a) decreasing the damping through release of the breaks and b) through added juggling of a ball during the motor task (dual-task and divided attention). The next stage is reached once stabilisation in the previous stage is secured.	Other: Proprioceptive postural training; Other Names: Sensorimotor training; Other: Conventional physiotherapy; All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.
Active Comparator: Low-intensity activity; Added to conventional therapy, as administered to all participants, the control group will do added treadmill walking. The control intervention will consist of 10 minutes of walking at comfortable pace. The patient will be instructed in treadmill functions and asked to set the speed between 2 and 4 km/h. The speed should be adjusted to the level where the patient would still be able to talk comfortably.	Other: Conventional physiotherapy; All participating patients will attend usual care according to their treatment plan (taking part in the study does not affect the treatment plan). A physiotherapy referral requests 9 treatments, each of which takes 30 minutes. These will take place twice a week for 4.5 weeks. The study protocol does not dictate the content of the physiotherapy sessions themselves, but detailed documentation of provided treatments is required (therapy documentation sheet). Additionally, the aim of the physiotherapy sessions should always include reduction of muscular imbalances and optimisation of posture.; Other: Treadmill training

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change of self-reported pain on 100mm Visual Analogue Scale (VAS)	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Change of functional status recorded with the Oswestry Disability Index (ODI)	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Centre of Pressure	Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Joint Repositioning Error (segmental)	Repositioning acuity after surface perturbation.	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Uncontrolled Manifold Index (UCM)	Segmental joint configuration.	Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

Collaborators and Investigators

• Sponsor: Michael A. McCaskey
• Collaborators: University of Zurich
• Investigators: Principal Investigator: Michael A McCaskey, MSc, Reha Rheinfelden; Study Chair: Eling D. de Bruin, PD PhD, ETH Zurich; Study Chair: Corina Schuster-Amft, PT PhD, Reha Rheinfelden

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): January 1, 2016

Study Registration Dates

• First Submitted: November 17, 2014
• First Submitted That Met QC Criteria: November 25, 2014
• First Posted (Estimate): December 1, 2014

Study Record Updates

• Last Update Posted (Estimate): April 6, 2016
• Last Update Submitted That Met QC Criteria: April 5, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: postural control; proprioception; sensorimotor training; uncontrolled manifold
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 2014-0873