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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04364243
• Other study ID #: BASEC-Nr: 2018-02132
• Status: Completed
• Phase: N/A
• Start date: May 20, 2019
• Est. completion date: October 23, 2020

Study information

• Verified date: April 2020
• Source: University of Zurich
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Other:
• Digitally supported home exercises
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.

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	ETH Zurich

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)
Secondary	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)