Sensorimotor Training in Low-back Pain Rehabilitation

NCT ID: NCT02304120

Last Updated: 2016-04-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-31

Study Completion Date

2016-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Low Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Proprioceptive postural training

Intervention Type OTHER

Conventional physiotherapy

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

Treadmill training

Intervention Type OTHER

Conventional physiotherapy

Intervention Type 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.

Interventions

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Proprioceptive postural training

Intervention Type OTHER

Treadmill training

Intervention Type 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.

Intervention Type OTHER

Other Intervention Names

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Sensorimotor training

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role collaborator

Michael A. McCaskey

OTHER

Sponsor Role lead

Responsible Party

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Michael A. McCaskey

Master of Science in Human Movement Science

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Michael A McCaskey, MSc

Role: PRINCIPAL_INVESTIGATOR

Reha Rheinfelden

Eling D. de Bruin, PD PhD

Role: STUDY_CHAIR

ETH Zurich

Corina Schuster-Amft, PT PhD

Role: STUDY_CHAIR

Reha Rheinfelden

Locations

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Reha Rheinfelden

Rheinfelden, Canton of Aargau, Switzerland

Site Status

Countries

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Switzerland

References

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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.

Reference Type BACKGROUND
PMID: 10382616 (View on PubMed)

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.

Reference Type DERIVED
PMID: 29522571 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26666457 (View on PubMed)

Other Identifiers

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2014-0873

Identifier Type: -

Identifier Source: org_study_id

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