AzTrials
AzTrials

Low Back PainSeMoPoPNCT02304120

Sensorimotor Training in Low-back Pain Rehabilitation

A study testing Proprioceptive postural training, Treadmill training and Conventional physiotherapy in people with Low Back Pain, run by Michael A. McCaskey at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Low Back Pain
What is being tested?
Proprioceptive postural training, Treadmill training and Conventional physiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteSwitzerland
Study dates
Dec 2014to Jan 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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)

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • Reha Rheinfelden

    Rheinfelden, Canton of Aargau, 4310

Other trials in Switzerland

About this study

Official title: 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.

Conditions
Low Back Pain
Being tested
Proprioceptive postural training, Treadmill training, Conventional physiotherapy
Keywords
proprioception, postural control, sensorimotor training, uncontrolled manifold
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Proprioceptive postural trainingOther

    Also called Sensorimotor training

  • Treadmill trainingOther

  • Conventional physiotherapyOther

    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.

Study groups in NCT02304120
Study groupRoleWhat they receive
SensorimotorExperimentalThe 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.
Receives: Other: Proprioceptive postural training; Other: Conventional physiotherapy
Low-intensity activityActive comparatorAdded 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.
Receives: Other: Treadmill training; Other: Conventional physiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change of self-reported pain on 100mm Visual Analogue Scale (VAS)

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

  2. Change of functional status recorded with the Oswestry Disability Index (ODI)

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

Secondary outcomes (3)

  1. Centre of Pressure

    Area of surface a the 95% confidence ellipse of centre of pressure displacement during postural task

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

  2. Joint Repositioning Error (segmental)

    Repositioning acuity after surface perturbation.

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

  3. Uncontrolled Manifold Index (UCM)

    Segmental joint configuration.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Dec 2014 (estimated)
  2. Study startDec 2014
  3. Primary completionDec 2015
  4. Study completionJan 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02304120
Sponsor's protocol ID
2014-0873
Acronym
SeMoPoP
Status last verified
Apr 2016
First submitted
17 Nov 2014
Last updated
6 Apr 2016
Results posted
No
Data monitoring committee
Yes

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.

    PubMed 10382616

  • 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.

    PubMed 29522571

  • 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.

    PubMed 26666457

Questions about this trial

What is this clinical trial studying?

A study testing Proprioceptive postural training, Treadmill training and Conventional physiotherapy in people with Low Back Pain, run by Michael A. McCaskey at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02304120, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in