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Completed

NCT Number: NCT02304120

Sensorimotor Training in Low-back Pain Rehabilitation

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Reha Rheinfelden

Rheinfelden, Canton of Aargau, 4310, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Proprioceptive postural training

Other

Other names: Sensorimotor training

Treadmill training

Other

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.

Primary outcomes

  1. 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)

  2. 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 outcomes

  1. Centre of Pressure

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

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

  2. Joint Repositioning Error (segmental)

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

    Repositioning acuity after surface perturbation.

  3. Uncontrolled Manifold Index (UCM)

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

    Segmental joint configuration.

Sponsors and collaborators

Lead sponsor

Michael A. McCaskey

Other

Collaborators

  • University of Zurich

Registry information

Official study title

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

Acronym: SeMoPoP

Important dates

Study start
2014
Primary completion
2015
Study completion
2016
First posted
Dec 1, 2014
Registry last updated
Apr 6, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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