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

NCT03571880 | Completed

• 1 other identifier: LBP-BIO-REL-001
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (8)

• 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).

  day1

• 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).

  day 2

• Abdominal dynamic strength

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

  day 1

• Abdominal dynamic strength

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

  day 2

• 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).

  day 1

• 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).

  day 2

• Back dynamic strength

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

  day 1

• Back dynamic strength

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

  day 2

Secondary Outcomes (3)

• Pain

  day 1

• The Modified Oswestry Disability Index (ODI)

  Day 1

• Physical Activities Scale For Individuals with Physical Disabilities (PASIPD)

  day 1

Study Arms (2)

CNSLBP group

EXPERIMENTAL

Device: Biodex-assisted isometric strength testing

Healthy control group

ACTIVE COMPARATOR

Device: Biodex-assisted isometric strength testing

Interventions

Biodex-assisted isometric strength testing 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).

CNSLBP group; Healthy control group

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hasselt University: lead
• Jessa Hospital: collaborator

Study Sites (2)

Hasselt University

Hasselt, 3500, Belgium

Location

Jessa Ziekenhuis

Hasselt, 3500, Belgium

Location

Related Publications (3)

• 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.

  PMID: 24665116 RESULT

• 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.

  PMID: 16550448 RESULT

• 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.

  PMID: 20640863 RESULT

Study Officials

• Jonas Verbrugghe, drs

  Hasselt University

  STUDY CHAIR

• Annick Timmermans, prof. dr.

  Hasselt University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: June 28, 2018
• Study Start: February 27, 2017
• Primary Completion: June 15, 2018
• Study Completion: June 15, 2018
• Last Updated: June 28, 2018

Record last verified: 2018-06

Locations

BE (2)