Low Back PainNCT04364243

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

A study testing Digitally supported home exercises in people with Low Back Pain, run by University of Zurich at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Low Back Pain
What is being tested?: Digitally supported home exercises
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 38 participants
Where: 1 siteSwitzerland
Study dates: 20 May 2019to 23 Oct 2020
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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
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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

University Hospital Zurich, Directorate of Research and Education, Physiotherapy & Occupational Therapy Research
Zurich, Canton of Zurich, 8091

Other trials in Switzerland

About this study

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.

Read the 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.

Conditions: Low Back Pain
Being tested: Digitally supported home exercises
Medical subject headings: Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Digitally supported home exercisesOther
Also called Valedo home
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.

Study groups in NCT04364243
Study group	Role	What they receive
Patients exercise	Experimental	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. Receives: Other: Digitally supported home exercises
Patients control	No intervention	Low back pain patients Group B will receive basic medical physical training therapy
Non-patients exercise	Experimental	non-patients Groups C will receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system. Receives: Other: Digitally supported home exercises
Non-patients control	No intervention	non-patients Group D will receive no intervention

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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 (7)

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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

20 May 201923 Oct 2020

First posted28 Apr 2020
Study start20 May 2019
Primary completion23 Oct 2020
Study completion23 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Low Back PainStudies of the same condition, open and under way.
More trials run by University of ZurichThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
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 blind
Who is masked: Outcomes assessor
Enrolment: 38 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04364243
Sponsor's protocol ID: BASEC-Nr: 2018-02132
Status last verified: Apr 2020
First submitted: 30 Oct 2019
Last updated: 5 Jan 2021
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Publication

Publications

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.
PubMed 35687390

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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LLLT to Reduce Low Back Pain
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A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
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Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
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PRP Versus NP Injections for Chronic Discogenic Low Back Pain
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Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
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All Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Pilot Study on Digitally Supported Home Exercises for the Management of Unspecific Low Back Pain.
ClinicalTrials.gov ID: NCT04364243
Acronym / sponsor ID: BASEC-Nr: 2018-02132
Conditions: Low Back Pain
Study type: Interventional
Recruitment status: Completed
Enrolment: 38 participants (actual)
Lead sponsor: University of ZurichUniversity, hospital or other
Collaborators: ETH Zurich
Study start: 20 May 2019 (actual)
Primary completion: 23 Oct 2020 (actual)
Study completion: 23 Oct 2020 (actual)
First posted: 28 Apr 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: Single blind (outcomes assessor)
Number of arms: 4
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.

Arm	Type	Receives
Patients exercise	Experimental	Other: Digitally supported home exercisesLow 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.
Patients control	No intervention	–Low back pain patients Group B will receive basic medical physical training therapy
Non-patients exercise	Experimental	Other: Digitally supported home exercisesnon-patients Groups C will receive a home exercising programme which involves 10 exercises for 2 minutes each with the Valedo training system.
Non-patients control	No intervention	–non-patients Group D will receive no intervention

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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
Participant reports unspecific low back pain

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Digitally supported home exercisesAlso: Valedo homeThe 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	Non-patients exercise, Patients exercise

Primary outcome

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.

7 secondary outcomes

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)
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)
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)
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)
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)
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)
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)

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2021.
Derived from this study: PubMed 35687390Meinke 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.
Individual participant dataSharing planned: No. Publication

Related trials for Low Back Pain

Active, not recruiting
LLLT to Reduce Low Back Pain
Low Back Pain
Recruiting
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
Nonspecific Low Back Pain, Low Back Pain
Recruiting
Chromatic Retinal Stimulation to Reduce Chronic Pain and Pain Sensitivity
Chronic Low-back Pain, Chronic Pain
Not yet recruitingPhase 2/3
PRP Versus NP Injections for Chronic Discogenic Low Back Pain
Discogenic Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jaap Swanenburg, PhD principal investigator

University of Zurich

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Digitally supported home exercises in people with Low Back Pain, run by University of Zurich at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04364243, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2021.