Clinical trial NCT03841552: Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise
Official title: Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: Low Back Pain
Lead sponsor: Zurich University of Applied Sciences
Sponsor class: OTHER
Collaborators: name: Danube University Krems
name: MedBase Brunngasse Winterthur
First posted: 2019-02-15
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized controlled pilot trial
Primary purpose: TREATMENT

Brief summary: Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control. In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group). The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.


Eligibility criteria: Inclusion Criteria:

* non specific low back pain for at least four weeks
* at least moderate disability (as indicated by an Oswestry disability index (ODI) \> 8% (Mannion et al., 2006))
* low levels of biopsychosocial risk factors (STarT Back Screening tool \> 4 points) (Hill et al., 2011)
* at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)

Exclusion Criteria:

* specific low back pain
* pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
* vertigo or equilibrium disturbances
* systemic diseases (e.g. tumours and diabetes)
* injuries
* surgeries of the legs within the last six months
* medication affecting postural control
* pregnancy

Primary outcomes:
measure: Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
timeFrame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
measure: Changes from Baseline of the mean absolute deviation of lumbar agular displacement
timeFrame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Secondary outcomes:
Other outcomes:
Locations:
city: Winterthur
country: Switzerland
facility: Zurich University of Applied Sciences
state: Zurich
Study officials:
References:
citation: Hugli AS, Ernst MJ, Kool J, Rast FM, Rausch-Osthoff AK, Mannig A, Oetiker S, Bauer CM. Adherence to home exercises in non-specific low back pain. A randomised controlled pilot trial. J Bodyw Mov Ther. 2015 Jan;19(1):177-85. doi: 10.1016/j.jbmt.2014.11.017. Epub 2014 Nov 27.