Clinical trial NCT04364243: Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.
Official title: Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Lead sponsor: University of Zurich
Sponsor class: OTHER
Collaborators: name: ETH Zurich
First posted: 2020-04-28
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 x 2. Stratified randomization are used to assign patients to groups A and B and participants not receiving treatment to groups C and D. Participants are stratified by an average height.
Primary purpose: TREATMENT

Brief summary: The overall purpose of the study is to investigate effect of Digitally Supported Home Exercises (DSHE) in different groups for which digitally supported interventions could be beneficial. Balance is altered in individuals with low back pain and requires intervention Thus, the investigators will focus on the effect of DSHE to improve postural balance.

Detailed description: The investigators want to investigate whether a digitally supported exercise program can improve the balance of people with non-specific lower back pain. During the exercise program, a computer game at home is controlled with the help of sensors attached to the body. Second aim is to record the daily activities of the participants and compare them with the back pain.

The 120 participants in this study will be divided into four groups (A, B, C and D). In groups A and B 20 patients are included who are in treatment for chronic back pain and receive Medical Training Therapy (MTT). For groups C and D the investigators will invite each 40 participants who have back pain but are not in treatment for their back pain. Only participants in groups A and C receive the digitally supported home exercise program. Who gets the training program is randomized using stratified block randomization.

The balance of all participants is measured four times. Between the 2nd and 3rd measurement the digitally supported exercise program is carried out. Between the 3rd and 4th assessement, participants in group A and C can exercise as much as they wish. The person who carries out the balance tests will not be informed which participant is in which group.

Eligibility criteria: Inclusion Criteria Group A and B

* Patients with chronic unspecific low back pain
* Patients of the Medical Training Therapy (MTT)
* Adult male and female participant's (≥18 years)
* Informed consent as documented by signature

Inclusion Criteria Group C and D

* Participant reports unspecific low back pain
* Receiving no therapy nor medical treatment for the last 6 months
* Adult male and female participant's (≥18 years)
* Informed consent as documented by signature

Exclusion criteria All Groups

* Patients with specific causes for low back pain
* Radicular syndrome
* Unable to participate currently in the program due to pain
* Pregnancy
* Medication effecting postural balance
* Uncorrected heavy visual impairment
* Allergy to adhesive tape
* Unable to understand and communicate in German or English

Primary outcomes:
measure: Postural Balance
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest2)
Secondary outcomes:
measure: Motor Control
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
measure: Low back pain intensity
timeFrame: At balseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
measure: Disability
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 ( posttest 2)
measure: Health quality of life
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
measure: Fear of movement
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
measure: Fear of specific movements
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
measure: Self-efficacy for managing chronic diseases
timeFrame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest 2)
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
state: ZH
Study officials:
affiliation: University of Zurich
name: Jaap Swanenburg, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meinke A, Peters R, Knols RH, Swanenburg J, Karlen W. Feedback on Trunk Movements From an Electronic Game to Improve Postural Balance in People With Nonspecific Low Back Pain: Pilot Randomized Controlled Trial. JMIR Serious Games. 2022 Jun 10;10(2):e31685. doi: 10.2196/31685.