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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00201513
Other study ID # REK 4.2005.1720
Secondary ID
Status Completed
Phase N/A
First received September 16, 2005
Last updated October 8, 2012
Start date January 2006
Est. completion date October 2008

Study information

Verified date October 2012
Source Norwegian University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority Norway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 99
Est. completion date October 2008
Est. primary completion date September 2007
Accepts healthy volunteers No
Gender Both
Age group 20 Years to 60 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Isolated Transversus abdominis (TrA) exercise
Eight weeks Isolated Transversus abdominis (TrA) exercise(low load) program; Isolated TrA control through biofeedback
sling exercise
Eight weeks sling(high load) exercise program; Isolated TrA control through biofeedback
group exercise
Eight weeks non-specific group exercise program; Isolated TrA control through biofeedback

Locations

Country Name City State
Norway Norwegian University of Science and Technology, National center for spinal diseases Trondheim

Sponsors (2)

Lead Sponsor Collaborator
Norwegian University of Science and Technology Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

References & Publications (3)

Unsgaard-Tøndel M, Fladmark AM, Salvesen Ø, 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: — View 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. — View Citation

Vasseljen O, Unsgaard-Tøndel 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: 10.10 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle activity onset in transversus abdominal muscle 1 year No
Secondary Pain 2 years No
Secondary Function (Oswestry v2) 2 years No
Secondary Fear of avoidance belief 1 year No
Secondary Assessment of isolated transversus abd. and multifidus control 1 year No
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