Sensorimotor Training in Low-back Pain Rehabilitation

Study Overview
=================
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.

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

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Other: Proprioceptive postural training
* Other: Treadmill training
* Other: Conventional physiotherapy


Participation Criteria
=================
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sensorimotor<br>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<br> <br> * Other names: Sensorimotor training;Other: Conventional physiotherapy<br>* 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.<br>|
| Active Comparator: Low-intensity activity<br>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: Treadmill training<br> <br> Other: Conventional physiotherapy<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
proprioception, postural control, sensorimotor training, uncontrolled manifold