|- candidate number||23478|
|- NTR Number||NTR5715|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||10-dec-2015|
|- Secondary IDs||M015-035 METC Noor Holland|
|- Public Title||The effect of therapy podopostural soles on chronic low back pain|
|- Scientific Title||The effect of therapy podopostural soles on chronic low back pain|
|- hypothesis||After two months, podopostural therapy has more effect on back and leg pain in people with (radiating) leg pain on the side where the ilium is higher than the other side compared to those with (radiating) leg pain on the side where the ilium is lower than the other side.|
|- Healt Condition(s) or Problem(s) studied||Low back pain (LBP), Podopostural therapy|
|- Inclusion criteria||Chronic low back pain (≥ 3 months) with or without radiation in the bone Age 18 years The person accepts the consequences of participation in the study
|- Exclusion criteria||Neuropathic pain Severe illness (eg. Malignancies) or suspicion on it Rheumatic diseases such as polymyalgia rheumatica, rheumatoid arthritis, lupus erythematosis Severe cardiovascular disease Central and peripheral neurological disorders (stroke, MS, Parkinson's, poly neuropathy, WAD grade 3 etc.) Insulin-dependent diabetes dementia Treatment for a psychiatric disorder Insufficient understanding of the Dutch language Pregnancy|
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||Single arm|
|- planned startdate ||13-mei-2014|
|- planned closingdate||1-dec-2017|
|- Target number of participants||50|
|- Primary outcome||The evaluation of the impact of podopostural therapy in subjects with chronic low back pain by 50 persons to deal with this complaint and following eighteen months.
|- Secondary outcome||The evaluation of the effects of podopostural therapy in specific subgroups with chronic low back pain.|
|- Timepoints||baseline and after 2, 5, 9 and 18 months|
|- Trial web site||www.podoalkmaar.nl|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| M.H.A.M. Koelman|
|- CONTACT for SCIENTIFIC QUERIES|| M.H.A.M. Koelman|
|- Sponsor/Initiator ||Podocentrum Alkmaar|
(Source(s) of Monetary or Material Support)
|Stichting LOOP, Podocentrum Alkmaar|
|- Brief summary||Background: For the treatment of low back pain are several methods. A popular and often used method is the manufacturing of specific insoles. The podopostural therapy uses millimeter thin insoles. There is hardly any research conducted into the effectiveness of podopostural therapy on low back pain.|
Objective: Primary objective: To evaluate the effect of podopostural therapy in subjects with chronic low back pain.
Secondary Objective: The evaluation of the effects of podopostural therapy in specific subgroups with chronic low back pain.
Study Design: Observational prospective cohort study.
Study population: Fifty people who sign up for treatment in primary care physical therapy practices with chronic low back pain with or without radiation into the leg.
Research: The subjects are treated according to the podopostural therapy and followed for eighteen months. The primary outcome variables are:
1. low back pain (numerical rating scale, 0-10), 2. leg pain (numerical rating scale, 0-10), 3. functionality (Oswestry Disability Index, 0-100) and 4 generally perceived recovery ( Likert scale 1-7).
Analysis: Linear mixed model analysis will be used in the evaluation of treatment outcomes for the total cohort. Linear mixed model analyzes will also be used to evaluate possible differences in treatment outcome between specific subgroups.
Risk in participation: There is no risk in participation. The treatment is usual care and does not change if the patient participate in this study.
|- Main changes (audit trail)|
|- RECORD||10-dec-2015 - 2-mei-2016|