Evidence map›Paper›PMID 25054648›Full record

Trial reportSpine2014

A randomized clinical trial comparing extensible and inextensible lumbosacral orthoses and standard care alone in the management of lower back pain.

David C Morrisette, Jacek Cholewicki, Sarah Logan, Gretchen Seif, Stephanie McGowan

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Spine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05100381 (Effectiveness of Dry Needling on Pain, Functional Disability, Postural Control and Pain Pressure Threshold in Patients With Chronic Nonspecific Low Back Pain), which is not on this map. Cited by 13 papers, 1 of them a synthesis that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 1 pooled it
–field-weighted citation impact
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.

NCT05100381 narecruitingnot on this mapstarted 2022, after this paper: background citation

Effectiveness of Dry Needling on Pain, Functional Disability, Postural Control and Pain Pressure Threshold in Patients With Chronic Nonspecific Low Back Pain: A Double-Blind Randomised Controlled Trial

TypeinterventionalSponsorIran University of Medical SciencesRan2022 to 2026Enrolled40ConditionsLow Back PainArmsdry needling, sham (placebo) dry needling
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 1 synthesis or guideline pooled it.

  1. Pooled it
  2. Trial
  3. Trial
  4. Article
  5. The Role of Orthoses in Chronic Axial Spinal Conditions.Current pain and headache reports · 2024
    Review
  6. Article
  7. Article
  8. Article
  9. Effectiveness of orthoses for treatment in patients with spinal pain.Yeungnam University journal of medicine · 2020
    Article
  10. Article
  11. Article
  12. Article
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

5 authors.

David C Morrisette*Division of Physical Therapy, College of Health Professions, Medical University of South Carolina, Charleston †Center for Orthopedic Research, Osteopathic Surgical Specialties, College of Osteopathic Medicine, Michigan State University, East Lancing ‡Family Services Research Center, Medical University of South Carolina, Charleston §Division of Physical Therapy, College of Health Professions, Medical University of South Carolina, Charleston; and ¶Department of Physical Therapy, Medical University of South Carolina Hospital Authority, Charleston.
Jacek Cholewicki
Sarah Logan
Gretchen Seif
Stephanie McGowan

Funding

South Carolina Clinical & Translational Research Institute (SCTR)UL1TR000062 · NCATS · MEDICAL UNIVERSITY OF SOUTH CAROLINA · PI BRADY, KATHLEEN T. · 2012 to 2014
$9.4M
NCATS NIH HHS UL1 TR000062
6 · The paper itself

Abstract

STUDY

designSingle blinded, randomized clinical trial for the evaluation of lumbosacral orthoses (LSOs) in the management of lower back pain (LBP).

objectiveTo evaluate the effects of two types of LSOs on self-rated disability in patients with LBP. SUMMARY OF BACKGROUND DATA: LSOs are commonly used for the management of LBP, but their effectiveness may vary because of design. An inextensible LSO (iLSO) reduces trunk motion and increases trunk stiffness, whereas an extensible LSO (eLSO) does not.

methodsA total of 98 participants with LBP were randomized to 3 groups: (1) standard care (SC) group, which included medication and physical therapy (n = 29), (2) SC with eLSO (eLSO group) (n = 32), and (3) SC with iLSO (iLSO group) (n = 37). Outcome measures were evaluated before and after 2 weeks of treatment: modified Oswestry Disability Index (ODI), Patient Specific Activity Scale, pain ratings, and Fear Avoidance Beliefs Questionnaire.

resultsThere were no statistically significant differences between groups at baseline. Compared with the SC alone, iLSO group showed greater improvement on the ODI scores (P = 0.01) but not the eLSO group. The ODI scores improved by a mean of 2.4 (95% confidence interval [CI], 2.2-7.1), 8.1 (95% CI, 2.8-13.4), and 14.0 (95% CI, 8.2-19.8) points for SC, eLSO, and iLSO groups, respectively. Individuals wearing the iLSO had 4.7 times higher odds of achieving 50% or greater improvement in the ODI scores than those assigned to SC (95% CI, 1.2-18.5, P = 0.03). Both the eLSO and iLSO groups had a greater improvement in the Patient Specific Activity Scale scores than the SC group (P = .05 and P = 0.01, respectively), but the change did not meet the minimal clinically important difference. Pain ratings improved for all 3 groups, with no statistical difference between them. Finally, no significant differences across groups were found for the Fear Avoidance Beliefs Questionnaire.

conclusionAn iLSO led to greater improvement in ODI scores than SC and an eLSO. We surmise that the likely mechanism responsible for this difference in outcome was the added trunk stiffness and motion restriction by the iLSO. LEVEL OF EVIDENCE: 2.

Indexed as

Orthotic DevicesAdultBiomechanical PhenomenaDisability EvaluationEquipment DesignFemaleHumansLow Back PainLumbar VertebraeMaleMiddle AgedNumbers Needed To TreatOrthopedic ProceduresPain MeasurementSacrumSingle-Blind Method

Identifiers

PMID25054648
PMCPMC4521401

What OpenQuestion holds

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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.