ISRCTN ISRCTN11898558
DOI https://doi.org/10.1186/ISRCTN11898558
Protocol serial number N/A
Sponsor South Ostrobothnia Central Hospital (Finland)
Funder South Ostrobothnia Central Hospital (EVO) (Finland)
Submission date
11/02/2011
Registration date
03/03/2011
Last edited
22/09/2015
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Musculoskeletal Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Satu Rannisto
Scientific

Hämeenpuisto 8B 15
Tampere
33210
Finland

Email satu.rannisto@sarastus.fi

Study information

Primary study designInterventional
Study designRandomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleThe efficacy of correction of leg length discrepancy on low back pain among meat industry workers
Study objectivesLeg length discrepancy may be related to low back pain in occupations with prolonged walking and/or standing.
Ethics approval(s)The Ethics Committee of South Ostrobothnia Central Hospital, 20/12/2006
Health condition(s) or problem(s) studiedLow back pain
InterventionUltrasound 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
Intervention typeOther
Primary outcome measure(s)

Intensity of low back pain (10 cm-VAS), measured at the beginning of the study and after 3, 6 and 12 months

Key secondary outcome measure(s)

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

Completion date05/02/2010

Eligibility

Participant type(s)Patient
Age groupAdult
SexAll
Target sample size at registration42
Key inclusion criteria1. 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
Key exclusion criteria1. Any spinal red flags
2. Nerve root entrapment
3. Any previous leg fractures behind leg length discrepancy
Date of first enrolment05/02/2009
Date of final enrolment05/02/2010

Locations

Countries of recruitment

  • Finland

Study participating centre

Hämeenpuisto 8B 15
Tampere
33210
Finland

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 07/05/2015 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes