Evidence map›Paper›PMID 15668775›Full record

Trial reportEuropean spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society2005

The effect of insoles on the incidence and severity of low back pain among workers whose job involves long-distance walking.

S Shabat, T Gefen, M Nyska, Y Folman, R Gepstein

2 registry-linked trialsOpen access · bronzeAbstract readRandomized Controlled Trial
In one paragraph

Trial report in European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 2005. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 12 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 4 pooled it
2.1field-weighted citation impact, top 14% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04746755 naterminatednot on this mapstarted 2019, after this paper: background citation

An Open-label, Single-centre, Parallel-group Clinical Investigation, to Evaluate the Effectiveness and In-use Tolerability of a Range of Four Orthotic Insoles on Target Areas of Pain in the Lower Body, Associated With Musculoskeletal Stress, Experienced by Those Who Spend Most of Their Working Day on Their Feet

TypeinterventionalSponsorReckitt Benckiser Healthcare (UK) LimitedRan2019 to 2020Enrolled145ConditionsMusculoskeletal PainArmsOrthotic Insole: Lower Back, Orthotic Insole: Heel, Orthotic Insole: Knee to Heel, Orthotic Insole: Arch
NCT05129540 naterminatednot on this mapstarted 2022, after this paper: background citation

Foot Orthoses in Patients With Chronic Sciatica Caused by Lumbar Disc Herniation: A Randomized Clinical Trial

TypeinterventionalSponsorUniversity of SevilleRan2022 to 2024Enrolled50ConditionsChronic Sciatica, Foot DeformityArmsCustom-made foot orthosis, Placebo orthosis
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 4 syntheses or guidelines pooled it, 54 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Imperfect placebos are common in low back pain trials: a systematic review of the literature.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2008
    Pooled it
  4. Insoles for prevention and treatment of back pain.The Cochrane database of systematic reviews · 2007
    Pooled it
  5. Trial
  6. Orthotic insoles do not prevent physical stress-induced low back pain.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2011
    Trial
  7. Article
  8. Shoes and Insoles: The Influence on Motor Tasks Related to Walking Gait Variability and Stability.International journal of environmental research and public health · 2020
    Article
  9. Article
  10. Article
  11. Article
  12. The Michel Benoist and Robert Mulholland yearly European Spine Journal review: a survey of the "surgical and research" articles in the European Spine Journal, 2005.European spine journal : official publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society · 2006
    Review
4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

5 authors at 2 institutions in 1 country.

S ShabatThe Orthopaedic Surgery Department, Spine Unit, Sapir Medical Center, Tel-Aviv Sackler Medical School, Kfar-Saba, Israel.
T Gefen
M Nyska
Y Folman
R Gepstein
Meir Medical Center · ILHillel Yaffe Medical Center · IL

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The prevalence and incidence of low back pain in general society is high. Workers whose job involves walking long distances have an even higher tendency to suffer from low back pain. A positive effect of insoles in reducing low back pain was found in professional sports players. This was not examined on people whose job involves walking long distances. In this double blind prospective study we examined the effectiveness of insoles constructed in a computerized method to placebo insoles in 58 employees whose work entailed extensive walking and who suffered from low back pain. The evaluation was performed by the MILLION questionnaire, which is considered as a valid questionnaire for evaluation of low back pain. We calculated the differences of the pain intensity before and after the intervention, in the employees using the insoles manufactured by computer in comparison to the users of the placebo insoles. In each group, the analysis was performed in comparison to the baseline. A total of 81% of the employees preferred the real insoles as effective and comfortable in comparison to 19% of the users of the placebo insoles (P<0.05). The results of this study indicate a substantial improvement in the low back pain after the use of the true insoles. The average pain intensity according to the MILLION questionnaire before the use of the insoles was 5.46. However, after the use of the real insoles and the placebo insoles, the average pain intensity decreased to 3.96 and 5.11, respectively. The difference of the average pain intensity at the start of the study and after the use of the real insoles was significant: -1.49 (P=0.0001), whereas this difference after the use of the placebo insoles was not significant: -0.31 (P=0.1189). The reported severity of pain also decreased significantly: a level 5 pain and above was reported by 77% of the subjects at the start of the study. After the use of the real insoles only 37.9% of the subjects reported a similar degree of pain severity, and 50% of the subjects did so after the use of the placebo insoles (P< 0.05). We did not find a link between low back pain and other variables such as gender, age, number of offspring, work seniority, smoking, previous use of insoles and previous medication. This study demonstrates that the low back pain decreased significantly after the use of real insoles compared to placebo ones.

Indexed as

ShoesAdultDouble-Blind MethodFemaleHumansIncidenceLow Back PainMaleMiddle AgedOccupational DiseasesPrevalenceProspective StudiesSeverity of Illness IndexSurveys and QuestionnairesWalking

Identifiers

PMID15668775
PMCPMC3489231
OpenAlexW1964441255

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.