Skip to content

Effect of orthosis on low back pain

Effect of lumbosacral orthosis on thickness/cross-sectional area of trunk muscle stabilizers using ultrasound imaging in patients with low back pain

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
IRCT
Registry ID
IRCT2015083123836N1
Enrollment
34
Registered
2015-11-02
Start date
2015-11-06
Completion date
Unknown
Last updated
2018-02-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Low back pain. Loin pain Low back strain Lumbago NOS

Interventions

Intervention 1: Patients in the experimental group will be prescribed a non-extensible lumbosacral orthosis over the whole duration of the trial, and during the whole day, with the exception of bedroo
Treatment - Other
Patients in the experimental group will be prescribed a non-extensible lumbosacral orthosis over the whole duration of the trial, and during the whole day, with the exception of bedroom and bathroom a
Patients in the control group will receive 8 physical treatment sessions for a period of 4 weeks (twice a week). Common physiotherapy modalities will comprise of moist heat, ultrasound, TENS, postur

Sponsors

Iran University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
20 Years to 55 Years

Inclusion criteria

Inclusion criteria: The subjects are included in LBP group if they meet the following criteria: age between 20 and 55 years, experience of back pain for at least for 12 months serious enough to require medical attention or absence from work, at least 1 episode of LBP in the last 6 month or pain with semicontinuous nature, no history of red flags, no history of core-strengthening exercise or physiotherapy and wearing orthosis during the past 6 month, no history of muscle relaxant medication, 3= VAS =7, ODI > 6. Individuals with a history of vestibular disorder, muscular dystrophy, neurological or sensory disorders, cardiac and respiratory disease, previous spinal surgery, serious neck problems, spinal structural deformity (kyphosis or scoliosis) , uncorrected vision impairment, vestibular disorder, pregnancy, diabetes, unequal length > 1 cm, osteoarthritis of hip and knee, BMI > 30, will be excluded. Also the subjects will be excluded if they have a hobby or job that requires extension of back or abdominal muscle training, a condition that requires prescription of muscle relax agents, or current use of analgesic medications other than acetaminophen (especially NSAD)

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
Thickness of Transversus abdominis and External oblique muscle. Timepoint: before & after 4 weeks intervention. Method of measurement: Ultrasound measurements, milimeter.;Cross-sectional area of multifidus. Timepoint: Before & after 4 weeks intervention. Method of measurement: Ultrasound measurements.

Secondary

MeasureTime frame
Pain intensity. Timepoint: Before and after 4 weeks intervention. Method of measurement: Visual analogue scale.;Disability. Timepoint: Before & after 4 weeks intervention. Method of measurement: Oswestry Disability Index.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Azadinia

School of Rehabilitation Sciences, Iran University of Medical Sciences

azadinia.fatemeh@yahoo.com+98 21 2222 8051

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026