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AzTrials

Chronic Low Back PainLBP-BIO-RELNCT03571880

Intra- And Inter-operator Reliability Of Isometric Back And Abdominal Muscle Strength Testing In Healthy Controls And Persons With Nonspecific Chronic Low Back Pain.

A study testing Biodex-assisted isometric strength testing in people with Chronic Low Back Pain, run by Hasselt University at 2 sites in Belgium.

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

Low back pain (LBP) is currently the most common cause of functional impairment with regard to the musculoskeletal system1. LBP occurs in men and women in all age groups and has a peak incidence between 30 and 65 years. Read more about this study

Who is it for?
Ages 25 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Biodex-assisted isometric strength testing
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
2 sitesBelgium
Study dates
27 Feb 2017to 15 Jun 2018
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 25 to 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • medically diagnosed with non-specific chronic low back pain,
  • between 25-60 years old,
  • able to understand Dutch (spoken and written).

Who cannot join

  • invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),
  • radiculopathy (uni- or bilateral),
  • co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, pregnancy,
  • ongoing compensation claims and/or (work)disability > 6 months,
  • rehabilitation/exercise therapy program for LBP in the past 6 months.

Trial locations and contacts

2 sites in 1 country.

Belgium2 sites

  • Hasselt University

    Hasselt, 3500

  • Jessa Ziekenhuis

    Hasselt, 3500

Other trials in Belgium

About this study

Low back pain (LBP) is currently the most common cause of functional impairment with regard to the musculoskeletal system1. LBP occurs in men and women in all age groups and has a peak incidence between 30 and 65 years. Although 10% of the persons with LRP can be diagnosed with a specific underlying pathology (e.g., disc herniation, canal stenosis, spondylolysis, ...), 90% have symptoms with an unclear origin. 23% of the latter group will eventually develop chronic nonspecific low back pain (CNSLBP)2.

Exercise therapy is seen as an important component in the rehabilitation of persons with CNSPLBP3. Because previous research showed reduced muscle strength of the back muscles4, exercise therapy that improves / recovers muscle strength is being investigated. However, there is still a lack of clarity concerning the effect that reduced muscle strength has on the development and further development of back pain5-6. The objective testing of back muscle strength remains a recurring issue. Up to now, back muscle strength has been mainly tested by a battery of clinical tests (eg Sorensen test) or the use of "iso machines"7. These Iso machines contain a dynamometer that can very specifically reflect the isometric or isokinetic force on an axis of rotation. Different types of these iso machines (eg Cybex, Biodex) have already been developed, each with specific designs (eg differences in the hip angle, differences in the stabilization of the participant). However, to date no standardized protocols are available for evaluating both abdominal and back muscle strength. Furthermore, it is also essential that before such systems can be used in clinical intervention studies, the reliability of such systems is investigated and that reference data from healthy subjects are collected with which data from patients can be compared.

The aim of the current research is therefore to investigate the intra- and inter-operator reliability of a standardized protocol drawn up according to the latest scientific evidence. A second goal is to set standard values for healthy persons for the developed protocol using the Biodex 3 dynamometer system.

Being tested
Biodex-assisted isometric strength testing

What participants receive

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

  • Biodex-assisted isometric strength testingDevice

    The maximum voluntary isometric and dynamic strength of back and abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

Study groups in NCT03571880
Study groupRoleWhat they receive
CNSLBP groupExperimentalNot described
Receives: Device: Biodex-assisted isometric strength testing
Healthy control groupActive comparatorNot described
Receives: Device: Biodex-assisted isometric strength testing

What is being measured

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

  1. abdominal isometric strength

    The maximum voluntary isometric strength of the abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day1

  2. Abdominal isometric strength

    The maximum voluntary isometric strength of the abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 2

  3. Abdominal dynamic strength

    The maximum voluntary dynamic strength of abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 1

  4. Abdominal dynamic strength

    The maximum voluntary dynamic strength of abdominal muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 2

  5. Back isometric strength

    The maximum voluntary isometric strength of the back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 1

  6. Back isometric strength

    The maximum voluntary isometric strength of the back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 2

  7. Back dynamic strength

    The maximum voluntary dynamic strength of back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 1

  8. Back dynamic strength

    The maximum voluntary dynamic strength of back muscles is measured using an isokinetic dynamometer (System 3, Biodex, Enraf-Nonius, New York).

    Measured: day 2

Secondary outcomes (3)

  1. Pain

    The Numeric Pain Rating Scale (NPRS) is a nominal scale on which the participant indicates the amount of pain he/she perceives at that current moment. It consists of a line indicating eleven successive scores (0-10), whereby score 0 means 'no pain' and score 10 means 'worst pain imaginable'. An improvement of 2 levels or more is accepted as clinically relevant.

    Measured: day 1

  2. The Modified Oswestry Disability Index (ODI)

    The Modified Oswestry Disability Index (ODI) is a valid and reliable questionnaire for evaluating constraints experienced by people in their daily activities due to chronic low back pain. It consists of 10 items that are scored on a 5-point scale. The total score gives a percentage degree of limitation for the patient.

    Measured: Day 1

  3. Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)

    The PASIPD is a questionnaire consisting of 13 items to measure the physical activity of people with disabilities. It provides information about leisure, household and work-related physical activity in the last 7 days.

    Measured: day 1

Timeline

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

  1. First posted28 Jun 2018
  2. Study start27 Feb 2017
  3. Primary completion15 Jun 2018
  4. Study completion15 Jun 2018

Resources

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
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03571880
Sponsor's protocol ID
LBP-BIO-REL-001
Acronym
LBP-BIO-REL
Status last verified
Jun 2018
First submitted
18 Jun 2018
Last updated
28 Jun 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Hoy D, March L, Brooks P, Blyth F, Woolf A, Bain C, Williams G, Smith E, Vos T, Barendregt J, Murray C, Burstein R, Buchbinder R. The global burden of low back pain: estimates from the Global Burden of Disease 2010 study. Ann Rheum Dis. 2014 Jun;73(6):968-74. doi: 10.1136/annrheumdis-2013-204428. Epub 2014 Mar 24.

    PubMed 24665116

  • Airaksinen O, Brox JI, Cedraschi C, Hildebrandt J, Klaber-Moffett J, Kovacs F, Mannion AF, Reis S, Staal JB, Ursin H, Zanoli G; COST B13 Working Group on Guidelines for Chronic Low Back Pain. Chapter 4. European guidelines for the management of chronic nonspecific low back pain. Eur Spine J. 2006 Mar;15 Suppl 2(Suppl 2):S192-300. doi: 10.1007/s00586-006-1072-1. No abstract available.

    PubMed 16550448

  • van Middelkoop M, Rubinstein SM, Kuijpers T, Verhagen AP, Ostelo R, Koes BW, van Tulder MW. A systematic review on the effectiveness of physical and rehabilitation interventions for chronic non-specific low back pain. Eur Spine J. 2011 Jan;20(1):19-39. doi: 10.1007/s00586-010-1518-3. Epub 2010 Jul 18.

    PubMed 20640863

Questions about this trial

What is this clinical trial studying?

A study testing Biodex-assisted isometric strength testing in people with Chronic Low Back Pain, run by Hasselt University at 2 sites in Belgium.

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 3 inclusion and 5 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 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Belgium. 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?

abdominal isometric strength (time frame: day1). The study lists 8 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 NCT03571880, which also lists 3 linked publications.

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 28 Jun 2018.

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