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Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain

Primary Purpose

Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Isolated Transversus abdominis (TrA) exercise
sling exercise
group exercise
Sponsored by
Norwegian University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring Muscle, Skeletal, Neuromuscular control, Stability, Exercise, Anticipatory muscle control

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Unspecific subacute, subacute remitting and chronic LBP Both sexes, 20-60 yrs of age LBP between 2-8 on a 11-pt numeric rating scale Exclusion Criteria: Previous back surgery Sick listed more than one year Radiating pain below knee or motor deficits Systemic diseases and "red flags" Diagnosed psychiatric disease Ingoing insurance claim Pregnancy

Sites / Locations

  • Norwegian University of Science and Technology, National center for spinal diseases

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

TrA exercise

sling exercise

group exercise

Arm Description

Isolated Transversus abdominis (TrA) exercises (low load)

Sling exercises (high load)

Non-specific group exercises

Outcomes

Primary Outcome Measures

Muscle activity onset in transversus abdominal muscle

Secondary Outcome Measures

Pain
Function (Oswestry v2)
Fear of avoidance belief
Assessment of isolated transversus abd. and multifidus control

Full Information

First Posted
September 16, 2005
Last Updated
October 8, 2012
Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy
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1. Study Identification

Unique Protocol Identification Number
NCT00201513
Brief Title
Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain
Official Title
Randomized Controlled Trial of Stabilizing Exercises and Effect on Anticipatory Muscle Control in Patients With Subacute and Chronic Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2012
Overall Recruitment Status
Completed
Study Start Date
January 2006 (undefined)
Primary Completion Date
September 2007 (Actual)
Study Completion Date
October 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Norwegian University of Science and Technology
Collaborators
Norwegian Fund for Postgraduate Training in Physiotherapy

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Muscular stability is essential to the spinal column to avoid harmful strain and injury to its structures. Sudden postural disturbances impose reactive internal forces through the spine. If the muscles do not react before the internal reactive forces propagate through the spine, there is a short fraction of time where the spinal column may lack sufficient muscular support. Studies have shown that in patients with low back pain deep abdominal and back muscle have a delayed response to reactive forces. The purpose of this study is to verify these findings and to investigate whether tailored interventions can improve the reaction time in stabilizing muscle around the lower spinal column i patients with subacute and chronic low back pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
Muscle, Skeletal, Neuromuscular control, Stability, Exercise, Anticipatory muscle control

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TrA exercise
Arm Type
Experimental
Arm Description
Isolated Transversus abdominis (TrA) exercises (low load)
Arm Title
sling exercise
Arm Type
Experimental
Arm Description
Sling exercises (high load)
Arm Title
group exercise
Arm Type
Active Comparator
Arm Description
Non-specific group exercises
Intervention Type
Behavioral
Intervention Name(s)
Isolated Transversus abdominis (TrA) exercise
Intervention Description
Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
Intervention Type
Behavioral
Intervention Name(s)
sling exercise
Intervention Description
Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
Intervention Type
Behavioral
Intervention Name(s)
group exercise
Intervention Description
Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback
Primary Outcome Measure Information:
Title
Muscle activity onset in transversus abdominal muscle
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Pain
Time Frame
2 years
Title
Function (Oswestry v2)
Time Frame
2 years
Title
Fear of avoidance belief
Time Frame
1 year
Title
Assessment of isolated transversus abd. and multifidus control
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Unspecific subacute, subacute remitting and chronic LBP Both sexes, 20-60 yrs of age LBP between 2-8 on a 11-pt numeric rating scale Exclusion Criteria: Previous back surgery Sick listed more than one year Radiating pain below knee or motor deficits Systemic diseases and "red flags" Diagnosed psychiatric disease Ingoing insurance claim Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ottar Vasseljen, PhD
Organizational Affiliation
National center for spinal diseases
Official's Role
Study Chair
Facility Information:
Facility Name
Norwegian University of Science and Technology, National center for spinal diseases
City
Trondheim
ZIP/Postal Code
7489
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
20671099
Citation
Unsgaard-Tondel M, Fladmark AM, Salvesen O, Vasseljen O. Motor control exercises, sling exercises, and general exercises for patients with chronic low back pain: a randomized controlled trial with 1-year follow-up. Phys Ther. 2010 Oct;90(10):1426-40. doi: 10.2522/ptj.20090421. Epub 2010 Jul 29.
Results Reference
result
PubMed Identifier
20621545
Citation
Vasseljen O, Fladmark AM. Abdominal muscle contraction thickness and function after specific and general exercises: a randomized controlled trial in chronic low back pain patients. Man Ther. 2010 Oct;15(5):482-9. doi: 10.1016/j.math.2010.04.004.
Results Reference
result
PubMed Identifier
22146280
Citation
Vasseljen O, Unsgaard-Tondel M, Westad C, Mork PJ. Effect of core stability exercises on feed-forward activation of deep abdominal muscles in chronic low back pain: a randomized controlled trial. Spine (Phila Pa 1976). 2012 Jun 1;37(13):1101-8. doi: 10.1097/BRS.0b013e318241377c.
Results Reference
result
PubMed Identifier
21791459
Citation
Unsgaard-Tondel M, Lund Nilsen TI, Magnussen J, Vasseljen O. Is activation of transversus abdominis and obliquus internus abdominis associated with long-term changes in chronic low back pain? A prospective study with 1-year follow-up. Br J Sports Med. 2012 Aug;46(10):729-34. doi: 10.1136/bjsm.2011.085506. Epub 2011 Jul 26.
Results Reference
derived

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Anticipatory Muscle Control and Effect of Stabilizing Exercises in Patients With Subacute and Chronic Low Back Pain

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