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Completed

NCT Number: NCT04364243

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research

Zurich, Canton of Zurich, 8091, Switzerland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Digitally supported home exercises

Other

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.

Other names: Valedo home

Primary outcomes

  1. Postural Balance

    Time frame: At baseline (pretest 1), 3 weeks after pretest 1 (pretest 2), 3 weeks after pretest 2 (posttest 1), 6 weeks after posttest 1 (posttest2)

    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.

Secondary outcomes

  1. Motor Control

    Time frame: 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)

    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.

  2. Low back pain intensity

    Time frame: 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)

    Numeric rating scale (0-10), 0 = no pain, 10 = worst imaginable pain

  3. Disability

    Time frame: 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)

    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

  4. Health quality of life

    Time frame: 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)

    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.

  5. Fear of movement

    Time frame: 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)

    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.

  6. Fear of specific movements

    Time frame: 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)

    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.

  7. Self-efficacy for managing chronic diseases

    Time frame: 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 disease 6-item scale (SES-6) Questionnaire. The mean scores are interpreted and are between 1 and 10. Higher values are the better outcome.

Sponsors and collaborators

Lead sponsor

University of Zurich

Other

Collaborators

  • ETH Zurich

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Apr 28, 2020
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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