Condition category
Musculoskeletal Diseases
Date applied
11/02/2011
Date assigned
03/03/2011
Last edited
22/09/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Satu Rannisto

ORCID ID

Contact details

Hämeenpuisto 8B 15
Tampere
33210
Finland
-
satu.rannisto@sarastus.fi

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

The efficacy of correction of leg length discrepancy on low back pain among meat industry workers

Acronym

Study hypothesis

Leg length discrepancy may be related to low back pain in occupations with prolonged walking and/or standing.

Ethics approval

The Ethics Committee of South Ostrobothnia Central Hospital, 20/12/2006

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Low back pain

Intervention

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

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

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

Secondary outcome measures

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

Overall trial start date

05/02/2009

Overall trial end date

05/02/2010

Reason abandoned

Eligibility

Participant inclusion criteria

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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

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.

Participant exclusion criteria

1. Any spinal red flags
2. Nerve root entrapment
3. Any previous leg fractures behind leg length discrepancy

Recruitment start date

05/02/2009

Recruitment end date

05/02/2010

Locations

Countries of recruitment

Finland

Trial participating centre

Hämeenpuisto 8B 15
Tampere
33210
Finland

Sponsor information

Organisation

South Ostrobothnia Central Hospital (Finland)

Sponsor details

Huhtalantie 53
Seinäjoki
60220
Finland
-
hannu.puolijoki@epshp.fi

Sponsor type

Hospital/treatment centre

Website

http://www.epshp.fi/

Funders

Funder type

Hospital/treatment centre

Funder name

South Ostrobothnia Central Hospital (EVO) (Finland)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25943907

Publication citations

Additional files

Editorial Notes