Low Back PainNCT03841552
Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise
A study testing Augmented Feedback in people with Low Back Pain, run by Zurich University of Applied Sciences at 1 site in Switzerland.
Trial summary
Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Augmented Feedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Oct 2012to 30 Apr 2013
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- non specific low back pain for at least four weeks
- at least moderate disability (as indicated by an Oswestry disability index (ODI) > 8% (Mannion et al., 2006))
- low levels of biopsychosocial risk factors (STarT Back Screening tool > 4 points) (Hill et al., 2011)
- at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)
Who cannot join
- specific low back pain
- pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
- vertigo or equilibrium disturbances
- systemic diseases (e.g. tumours and diabetes)
- injuries
- surgeries of the legs within the last six months
- medication affecting postural control
- pregnancy
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Zurich University of Applied Sciences
Winterthur, Canton of Zurich, 8400
About this study
Official title: Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial
Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control. In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group). The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.
- Conditions
- Low Back Pain
- Being tested
- Augmented Feedback, Control Group
- Keywords
- Low Back Pain
- 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.
Augmented FeedbackDevice
An inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
Control GroupOther
Conventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises.
| Study group | Role | What they receive |
|---|---|---|
| Augmented Feedback | Experimental | The exercises were conducted with the aim of improving postural- and movement control and awareness of the lumbar spine in both treatment groups. Both groups received nine 30-minute therapy sessions, during which they performed a series of exercises from an exercise catalogue. The exercises were selected based on their compatibility with the AF-system. Each patient performed impairment-specific exercises. The AF group received additional AF feedback during both the therapy sessions and the home exercise program, by combining the exercises with games designed to target movement control, body awareness, and stabilisation exercises. Receives: Device: Augmented Feedback |
| Control Group | Active comparator | The control group performed the impairment-specific exercises without AF. The control group was able to receive conventional visual feedback, such as use of mirrors, as deemed appropriate by the therapists but no AF. Receives: Other: Control Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)
Measured: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Changes from Baseline of the mean absolute deviation of lumbar agular displacement
Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)
Measured: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2019
- Study start1 Oct 2012
- Primary completion30 Apr 2013
- Study completion30 Apr 2013
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.
- 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
- Parallel groups
- Model description
- Randomized controlled pilot trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zurich University of Applied Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Danube University Krems, MedBase Brunngasse Winterthur
- Responsible party
- Principal investigator, Markus J. Ernst, Zurich University of Applied Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03841552
- Sponsor's protocol ID
- KEK-ZH-Nr. 2011-0522
- Status last verified
- Feb 2019
- First submitted
- 5 Feb 2019
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hugli AS, Ernst MJ, Kool J, Rast FM, Rausch-Osthoff AK, Mannig A, Oetiker S, Bauer CM. Adherence to home exercises in non-specific low back pain. A randomised controlled pilot trial. J Bodyw Mov Ther. 2015 Jan;19(1):177-85. doi: 10.1016/j.jbmt.2014.11.017. Epub 2014 Nov 27.
PubMed 25603757
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Augmented Feedback on Lumbar Postural and Movement Control During Physiotherapy and Home Exercise - A Randomized Controlled Pilot Trial
- ClinicalTrials.gov ID
- NCT03841552
- Acronym / sponsor ID
- KEK-ZH-Nr. 2011-0522
- Conditions
- Low Back Pain
- Keywords
- Low Back Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zurich University of Applied SciencesUniversity, hospital or other
- Collaborators
- Danube University Krems, MedBase Brunngasse Winterthur
- Study start
- 1 Oct 2012 (actual)
- Primary completion
- 30 Apr 2013 (actual)
- Study completion
- 30 Apr 2013 (actual)
- First posted
- 15 Feb 2019 (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.
Exercise therapy is effective in improving pain experience and disability in patients with non-specific low back pain (NSLBP) and movement/postural control impairments. However, patients often find traditional exercises monotonous and discontinue their execution. Augmented feedback tools (AF) might improve patient adherence and therapy outcomes, but evidence is currently lacking on their effects on movement/postural control. In a pilot randomised controlled trial (RCT) on a population of patients with NSLBP and movement control impairment, treatment with physiotherapy and home exercise supported by AF is compared to traditional physiotherapy and home exercise treatment without AF (control group). The primary outcomes are defined as lumbar movement control and postural control, measured using an inertial measurement system.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized controlled pilot trial
| Arm | Type | Receives |
|---|---|---|
| Augmented Feedback | Experimental | Device: Augmented FeedbackThe exercises were conducted with the aim of improving postural- and movement control and awareness of the lumbar spine in both treatment groups. Both groups received nine 30-minute therapy sessions, during which they performed a series of exercises from an exercise catalogue. The exercises were selected based on their compatibility with the AF-system. Each patient performed impairment-specific exercises. The AF group received additional AF feedback during both the therapy sessions and the home exercise program, by combining the exercises with games designed to target movement control, body awareness, and stabilisation exercises. |
| Control Group | Active comparator | Other: Control GroupThe control group performed the impairment-specific exercises without AF. The control group was able to receive conventional visual feedback, such as use of mirrors, as deemed appropriate by the therapists but no AF. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- non specific low back pain for at least four weeks
- at least moderate disability (as indicated by an Oswestry disability index (ODI) > 8% (Mannion et al., 2006))
- low levels of biopsychosocial risk factors (STarT Back Screening tool > 4 points) (Hill et al., 2011)
- at least two positive movement control impairment tests (Luomajoki et al., 2008, Sahrmann, 2002)
Key exclusion criteria (8 listed)
- specific low back pain
- pain in other areas of the body (e.g. neck, head, thoracic spine or arms)
- vertigo or equilibrium disturbances
- systemic diseases (e.g. tumours and diabetes)
- injuries
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 |
|---|---|---|
| Augmented FeedbackAn inertial measurement unit (IMU) system is the basis of the augmented feedback (AF) system, where the IMU-system communicates with a laptop using a bluetooth dongle. The corresponding software includes therapeutic games. Movements of the lower back and pelvis by the patient are used to control an avatars movement or the graphical interface in computer exercises. The AF-system provides real-time feedback regarding the patient's performance and helps to rectify incorrect execution of the exercises. The intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises. | Device | Augmented Feedback |
| Control GroupConventional impairment-specific physiotherapy exercises for low back pain patients.The control intervention took place at a physiotherapy clinic and in an home environment. In the physiotherapy clinic the patients exercised under the supervision of the physiotherapists. They continued the exercises at home as home exercises. | Other | Control Group |
Primary outcome
Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip)
Time frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Movement control was quantified using the ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) during the movement control test (lumbar spine (LS) over the hip)
Changes from Baseline of the mean absolute deviation of lumbar agular displacement
Time frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)
Postural control was quantified using the mean absolute deviation of lumbar angular displacement (MAD)
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 15 Feb 2019.
- Background: PubMed 25603757Hugli AS, Ernst MJ, Kool J, Rast FM, Rausch-Osthoff AK, Mannig A, Oetiker S, Bauer CM. Adherence to home exercises in non-specific low back pain. A randomised controlled pilot trial. J Bodyw Mov Ther. 2015 Jan;19(1):177-85. doi: 10.1016/j.jbmt.2014.11.017. Epub 2014 Nov 27.
- Individual participant dataSharing planned: No
Related trials for Low Back Pain
Not yet recruiting
Effects of Hip Hinge Exercises on Pain, Range of Motion and Functional Disability in Non-specific Low Back Pain.
Low Back Pain
Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Effects of Whole-Body Vibration and Cervical Stabilization With Core Stabilization in Young Adults With Non-Specific Low Back Pain
Nonspecific Low Back Pain
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Augmented Feedback in people with Low Back Pain, run by Zurich University of Applied Sciences 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 4 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 15 Feb 2019. 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?
Change from Baseline ratio of the range of motion (ROM) of the stabilized lumbar spine (ROMLS) over the moving body segment, the hip (ROMHip) (time frame: From Baseline to the completion of nine physiotherapy sessions, which are completed after a maximum of five weeks (Swiss standard prescription)). The study lists 2 primary outcomes in all. 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 NCT03841552, 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 15 Feb 2019.