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

NCT ID: NCT03571880

Last Updated: 2018-06-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-27
• Study Completion Date: 2018-06-15

Brief 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. 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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

CNSLBP group

Group Type: EXPERIMENTAL

Biodex-assisted isometric strength testing

Intervention Type: DEVICE

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).

Healthy control group

Group Type: ACTIVE_COMPARATOR

Biodex-assisted isometric strength testing

Intervention Type: DEVICE

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).

Interventions

Biodex-assisted isometric strength testing

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).

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

1. medically diagnosed with non-specific chronic low back pain,

2. between 25-60 years old,

3. able to understand Dutch (spoken and written).

Exclusion Criteria

1. invasive surgery at the lumbar spine in the last 18 months (arthrodesis was excluded, microsurgery was allowed),

2. radiculopathy (uni- or bilateral),

3. co-morbidities: paresis and/or sensory disturbances by neurological causes, diabetes mellitus, rheumatoid arthritis, pregnancy,

4. ongoing compensation claims and/or (work)disability > 6 months,

5. rehabilitation/exercise therapy program for LBP in the past 6 months.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Jessa Hospital

OTHER

Sponsor Role: collaborator

Hasselt University

OTHER

Sponsor Role: lead

Responsible Party

Annick Timmermans

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonas Verbrugghe, drs

Role: STUDY_CHAIR

Hasselt University

Annick Timmermans, prof. dr.

Role: PRINCIPAL_INVESTIGATOR

Hasselt University

Locations

Hasselt University

Hasselt, , Belgium

Jessa Ziekenhuis

Hasselt, , Belgium

Countries

Belgium

References

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.

Reference Type: RESULT

PMID: 24665116 (View on PubMed)

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.

Reference Type: RESULT

PMID: 16550448 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20640863 (View on PubMed)

Other Identifiers

LBP-BIO-REL-001

Identifier Type: -

Identifier Source: org_study_id