Sensorimotor Training in Low-back Pain Rehabilitation

NCT02304120 | Completed DMC

• 1 other identifier: 2014-0873
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

proprioception; postural control; sensorimotor training; uncontrolled manifold

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• Centre of Pressure

  Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

• Joint Repositioning Error (segmental)

  Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

• Uncontrolled Manifold Index (UCM)

  Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

Study Arms (2)

Sensorimotor

EXPERIMENTAL

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: Conventional physiotherapy

Low-intensity activity

ACTIVE COMPARATOR

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; Other: Conventional physiotherapy

Interventions

Proprioceptive postural training OTHER

Also known as: Sensorimotor training

Sensorimotor

Treadmill training OTHER

Low-intensity activity

Conventional physiotherapy OTHER

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.

Low-intensity activity; Sensorimotor

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Michael A. McCaskey: lead
• University of Zurich: collaborator

Study Sites (1)

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Location

Related Publications (3)

• 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.

  PMID: 10382616 BACKGROUND

• 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.

  PMID: 29522571 DERIVED

• 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.

  PMID: 26666457 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Michael A McCaskey, MSc

  Reha Rheinfelden

  PRINCIPAL INVESTIGATOR

• Eling D. de Bruin, PD PhD

  ETH Zurich

  STUDY CHAIR

• Corina Schuster-Amft, PT PhD

  Reha Rheinfelden

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Master of Science in Human Movement Science

Study Record Dates

• First Submitted: November 17, 2014
• First Posted: December 1, 2014
• Study Start: December 1, 2014
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: April 6, 2016

Record last verified: 2016-04

Locations

CH (1)