NCT00201513

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2006

Longer than P75 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 16, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3 months until next milestone

Study Start

First participant enrolled

January 1, 2006

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

October 10, 2012

Status Verified

October 1, 2012

Enrollment Period

1.7 years

First QC Date

September 16, 2005

Last Update Submit

October 8, 2012

Conditions

Keywords

Muscle, SkeletalNeuromuscular controlStabilityExerciseAnticipatory muscle control

Outcome Measures

Primary Outcomes (1)

  • Muscle activity onset in transversus abdominal muscle

    1 year

Secondary Outcomes (4)

  • Pain

    2 years

  • Function (Oswestry v2)

    2 years

  • Fear of avoidance belief

    1 year

  • Assessment of isolated transversus abd. and multifidus control

    1 year

Study Arms (3)

TrA exercise

EXPERIMENTAL

Isolated Transversus abdominis (TrA) exercises (low load)

Behavioral: Isolated Transversus abdominis (TrA) exercise

sling exercise

EXPERIMENTAL

Sling exercises (high load)

Behavioral: sling exercise

group exercise

ACTIVE COMPARATOR

Non-specific group exercises

Behavioral: group exercise

Interventions

Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback

TrA exercise
sling exerciseBEHAVIORAL

Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback

sling exercise
group exerciseBEHAVIORAL

Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback

group exercise

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Trondheim, Trondheim, 7489, Norway

Location

Related Publications (4)

  • 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.

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

Low Back PainMotor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Ottar Vasseljen, PhD

    National center for spinal diseases

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 16, 2005

First Posted

September 20, 2005

Study Start

January 1, 2006

Primary Completion

September 1, 2007

Study Completion

October 1, 2008

Last Updated

October 10, 2012

Record last verified: 2012-10

Locations