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Sensorimotor Training in Low-back Pain Rehabilitation (SeMoPoP)

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Proprioceptive postural training
Treadmill training
Conventional physiotherapy
Sponsored by
Michael A. McCaskey
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring proprioception, postural control, sensorimotor training, uncontrolled manifold

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Reha Rheinfelden

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Sensorimotor

Low-intensity activity

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
Change of functional status recorded with the Oswestry Disability Index (ODI)

Secondary Outcome Measures

Centre of Pressure
Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task
Joint Repositioning Error (segmental)
Repositioning acuity after surface perturbation.
Uncontrolled Manifold Index (UCM)
Segmental joint configuration.

Full Information

First Posted
November 17, 2014
Last Updated
April 5, 2016
Sponsor
Michael A. McCaskey
Collaborators
University of Zurich
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1. Study Identification

Unique Protocol Identification Number
NCT02304120
Brief Title
Sensorimotor Training in Low-back Pain Rehabilitation
Acronym
SeMoPoP
Official Title
Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2014 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michael A. McCaskey
Collaborators
University of Zurich

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
proprioception, postural control, sensorimotor training, uncontrolled manifold

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Sensorimotor
Arm Type
Experimental
Arm Description
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.
Arm Title
Low-intensity activity
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Proprioceptive postural training
Other Intervention Name(s)
Sensorimotor training
Intervention Type
Other
Intervention Name(s)
Treadmill training
Intervention Type
Other
Intervention Name(s)
Conventional physiotherapy
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change of self-reported pain on 100mm Visual Analogue Scale (VAS)
Time Frame
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Title
Change of functional status recorded with the Oswestry Disability Index (ODI)
Time Frame
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Secondary Outcome Measure Information:
Title
Centre of Pressure
Description
Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task
Time Frame
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Title
Joint Repositioning Error (segmental)
Description
Repositioning acuity after surface perturbation.
Time Frame
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)
Title
Uncontrolled Manifold Index (UCM)
Description
Segmental joint configuration.
Time Frame
Baseline (-4 days); Pre-Test (0 days); Post-Test (+25 days) and follow-up (+45 days)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael A McCaskey, MSc
Organizational Affiliation
Reha Rheinfelden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Eling D. de Bruin, PD PhD
Organizational Affiliation
ETH Zurich
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Corina Schuster-Amft, PT PhD
Organizational Affiliation
Reha Rheinfelden
Official's Role
Study Chair
Facility Information:
Facility Name
Reha Rheinfelden
City
Rheinfelden
State/Province
Aargau
ZIP/Postal Code
4310
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
10382616
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.
Results Reference
background
PubMed Identifier
29522571
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.
Results Reference
derived
PubMed Identifier
26666457
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.
Results Reference
derived

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Sensorimotor Training in Low-back Pain Rehabilitation

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