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Trial record 1 of 1 for:    NCT02304120
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Sensorimotor Training in Low-back Pain Rehabilitation (SeMoPoP)

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ClinicalTrials.gov Identifier: NCT02304120
Recruitment Status : Completed
First Posted : December 1, 2014
Last Update Posted : April 6, 2016
Sponsor:
Collaborator:
University of Zurich
Information provided by (Responsible Party):
Michael A. McCaskey, Reha Rheinfelden

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.

Condition or disease Intervention/treatment Phase
Low Back Pain Other: Proprioceptive postural training Other: Treadmill training Other: Conventional physiotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of a Sensorimotor Training on Postural Control and Pain: A Parallel, Single-blinded Randomised Controlled Trial
Study Start Date : December 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Arm Intervention/treatment
Experimental: Sensorimotor
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 Name: Sensorimotor training

Other: Conventional physiotherapy
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.

Active Comparator: Low-intensity activity
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
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 Measures :
  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 Outcome Measures :
  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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02304120


Locations
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Switzerland
Reha Rheinfelden
Rheinfelden, Aargau, Switzerland, 4310
Sponsors and Collaborators
Michael A. McCaskey
University of Zurich
Investigators
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Principal Investigator: Michael A McCaskey, MSc Reha Rheinfelden
Study Chair: Eling D. de Bruin, PD PhD ETH Zurich
Study Chair: Corina Schuster-Amft, PT PhD Reha Rheinfelden
Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Michael A. McCaskey, Master of Science in Human Movement Science, Reha Rheinfelden
ClinicalTrials.gov Identifier: NCT02304120    
Other Study ID Numbers: 2014-0873
First Posted: December 1, 2014    Key Record Dates
Last Update Posted: April 6, 2016
Last Verified: April 2016
Keywords provided by Michael A. McCaskey, Reha Rheinfelden:
proprioception
postural control
sensorimotor training
uncontrolled manifold
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations