Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.

Study Overview
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Brief Summary
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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
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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.

Official Title
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Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.

Conditions
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Low Back Pain

Intervention / Treatment
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* Other: Digitally supported home exercises


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Interventional 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.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients exercise<br>Low back pain patients Next to basic medical physical training therapy group A receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system. | Other: Digitally supported home exercises<br>* The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.<br>* Other names: Valedo home;|
| No Intervention: Patients control<br>Low back pain patients Group B will receive basic medical physical training therapy | |
| Experimental: Non-patients exercise<br>non-patients Groups C will receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system. | Other: Digitally supported home exercises<br>* The training will comprise of 9 sessions (3 weekly) Each of the training sessions will last 20 minutes. This will result in a cumulative total intervention exercise time of 180 minutes.<br>* Other names: Valedo home;|
| No Intervention: Non-patients control<br>non-patients Group D will receive no intervention | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postural Balance | Change of postural sway in anterior- posterior direction. Larger sway indicates worse balance. During each visit, 4 assessment repetitions of each 120 seconds are performed. | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motor Control | Lumbar spine and hip angles during task performance. Larger lumbar spine angles describe worse performance. Performance is assessed during a box lifting task and a waiter's bow task. At each assessment visit 5 repetitions of each task are performed. | 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) | 
| Low back pain intensity | Numeric rating scale (0-10), 0 = no pain, 10 = worst imaginable pain | 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) | 
| Disability | The Roland-Morris Disability Questionnaire (RMDQ) is used to assess disability. Scores range from 0 to 24, with a value of 24 indicating higher disability | 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) | 
| Health quality of life | The short version of the World Health Organization Quality of Life Questionnaire (WOOQOL-BREF) is used to assess quality of Life. The scale has 4 subscales (raw scores range from 7 to 35, 6 to 30, 3 to 15 and 8 to 38). Larger values describe the better quality of life. | 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) | 
| Fear of movement | The short version of the Tampa Scale for Kinesiophobia (TSK-11) Questionnaire is used to assess fear of movement. The TSK-11 scores range from 11 to 44, with higher scores describing higher fear of movement. | 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) | 
| Fear of specific movements | Ratings of six movements (forward bending, backward bending, sideways bending, rotating, lifting a box, stretching upward) on each how painful or harmful a movement is and how careful a person is when executing the movement. Ratings range from 0 to 100. Large numbers indicate higher painfulness, fearfulness or caution when executing each movement. | 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) | 
| Self-efficacy for managing chronic diseases | Self-efficacy for managing chronic disease 6-item scale (SES-6) Questionnaire. The mean scores are interpreted and are between 1 and 10. Higher values are the better outcome. | 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) |