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ISRCTN
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ISRCTN11898558
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ClinicalTrials.gov identifier
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Public title
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The role of leg length discrepancy in low back pain
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Scientific title
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The efficacy of correction of leg length discrepancy on low back pain among meat industry workers
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Acronym
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N/A
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Serial number at source
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N/A
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Study hypothesis
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Leg length discrepancy may be related to low back pain in occupations with prolonged walking and/or standing.
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Lay summary
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Ethics approval
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The Ethics Committee of South Ostrobothnia Central Hospital approved on 20th December 2006
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Study design
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Randomised controlled trial
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Countries of recruitment
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Finland
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Disease/condition/study domain
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Low back pain
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Participants - inclusion criteria
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1. Any current low back pain [at least one on a 10-cm Visual Analog Scale (VAS)] and leg length discrepancy of at least 5 mm (measured with a laser-based method)
2. Workers with prolonged occupational standing and/or walking within meat industry (carvers and packers)
3. Exposure to occupational standing and/or walking of at least 10 years
4. Age 35 years or more
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Participants - exclusion criteria
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1. Any spinal red flags
2. Nerve root entrapment
3. Any previous leg fractures behind leg length discrepancy
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Anticipated start date
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05/02/2009
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Anticipated end date
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05/02/2010
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Status of trial
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Completed |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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All workers fullfilling inclusion criteria within one meat factory in South Ostrobothnia.
20 participants in the intervention group and 22 participants in the control group.
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Interventions
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Ultrasound is used to measure both legs of the participants and the leg length discrepancy (LLD) 5mm or more. We also ask, if the participants have low back pain (LBP) scale 1-10. Then we randomise them in two groups.
In the intervention group the participants are given soles which correct 70% of LLD. In the control group the participants are given soles without correction. We ask questions(Oswestry, Roland -Morris, RAND, pain scales) at the beginning of the study and after 3, 6 and 12 months
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Primary outcome measure(s)
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Intensity of low back pain (10 cm-VAS), measured at the beginning of the study and after 3, 6 and 12 months
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Secondary outcome measure(s)
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1. Oswestry Disability
2. Roland-Morris Disability
3. RAND-36 Quality of Life
Measured at at the beginning of the study and after 3, 6 and 12 months
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Sources of funding
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South Ostrobothnia Central Hospital (EVO) (Finland)
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Trial website
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Publications
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Contact name
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Dr
Satu
Rannisto
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Address
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Hämeenpuisto 8B 15
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City/town
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Tampere
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Zip/Postcode
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33210
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Country
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Finland
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Email
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satu.rannisto@sarastus.fi
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Sponsor
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South Ostrobothnia Central Hospital (Finland)
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Address
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Huhtalantie 53,
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City/town
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Seinäjoki
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Zip/Postcode
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60220
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Country
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Finland
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Email
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hannu.puolijoki@epshp.fi
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Sponsor website:
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http://www.epshp.fi/
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Date applied
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11/02/2011
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Last edited
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03/03/2011
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Date ISRCTN assigned
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03/03/2011
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