Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise

Low Back Pain Clinical Trial

Official title:

Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03841552
• Other study ID #: KEK-ZH-Nr. 2011-0522
• Status: Completed
• Phase: N/A
• Start date: October 1, 2012
• Est. completion date: April 30, 2013

Study information

• Verified date: February 2019
• Source: Zurich University of Applied Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 30, 2013
• Est. primary completion date: April 30, 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Device:
• Augmented Feedback
An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.

Other:
• Control Group
Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.

Locations

Country	Name	City	State
Switzerland	Zurich University of Applied Sciences	Winterthur	Zurich

Sponsors (3)

Lead Sponsor	Collaborator
Zurich University of Applied Sciences	Danube University Krems, MedBase Brunngasse Winterthur

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Hügli 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)	Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)	From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Primary	Changes from Baseline of the mean absolute deviation of lumbar agular displacement	Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)	From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)