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

NCT04364243 | Completed

• 1 other identifier: BASEC-Nr: 2018-02132
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Motor Control

  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

  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

  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

  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

  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)

Study Arms (4)

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.

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.

Other: Digitally supported home exercises

Non-patients control

NO INTERVENTION

non-patients Group D will receive no intervention

Interventions

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.

Also known as: Valedo home

Non-patients exercise; Patients exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Zurich: lead
• ETH Zurich: collaborator

Study Sites (1)

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

Zurich, Canton of Zurich, 8091, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 35687390 DERIVED

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Jaap Swanenburg, PhD

  University of Zurich

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants will be informed, instructed and provide consent to the study assistant, while assessments will be taken by a measurement assistant, blinded to the group assignment. Data which is not collected in all groups (e.g. intervention adherence) will be collected and managed by the study assistant.
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 30, 2019
• First Posted: April 28, 2020
• Study Start: May 20, 2019
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)