Evidence map›Paper›PMID 24410959›Full record

Trial reportBMC complementary and alternative medicine2014

A path analysis of the effects of the doctor-patient encounter and expectancy in an open-label randomized trial of spinal manipulation for the care of low back pain.

Mitchell Haas, Darcy Vavrek, Moni B Neradilek, Nayak Polissar

Registry-linked trialOpen access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC complementary and alternative medicine, 2014. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00376350 (Dose-Response/Efficacy of Manipulation for Chronic LBP), which is not on this map. Cited by 12 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 3 pooled it
3.2field-weighted citation impact, top 9% 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.

NCT00376350 phase2 / phase3completednot on this map

Dose-Response/Efficacy of Manipulation for Chronic LBP

TypeinterventionalSponsorUniversity of Western StatesRan2007 to 2011Enrolled400ConditionsLow Back PainArmsSpinal Manipulation, Light Massage, Pulsed Ultrasound
3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 3 syntheses or guidelines pooled it, 33 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Manipulation and mobilization for treating chronic low back pain: a systematic review and meta-analysis.The spine journal : official journal of the North American Spine Society · 2018
    Pooled it
  4. Trial
  5. Trial
  6. Trial
  7. Trial
  8. Trial
  9. Review
  10. Article
  11. Article
  12. 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

4 authors at 2 institutions in 1 country.

Mitchell HaasCenter for Outcomes Studies, University of Western States, 2900 NE 132nd Ave,, Portland, OR, USA. mhaas@uws.edu.
Darcy Vavrek
Moni B Neradilek
Nayak Polissar
The Mountain Institute · USUniversity of Western States · US

Funding

Dose-Response/Efficacy of Manipulation for Chronic LBPU01AT001908 · NCCIH · UNIVERSITY OF WESTERN STATES · PI HAAS, MITCHELL · 2006 to 2010
$2.8M
NCCIH NIH HHS U01 AT001908
6 · The paper itself

Abstract

backgroundThe doctor-patient encounter (DPE) and associated patient expectations are potential confounders in open-label randomized trials of treatment efficacy. It is therefore important to evaluate the effects of the DPE on study outcomes.

methodsFour hundred participants with chronic low back pain (LBP) were randomized to four dose groups: 0, 6, 12, or 18 sessions of spinal manipulation from a chiropractor. Participants were treated three times per week for six weeks. They received light massage control at visits when manipulation was not scheduled. Treating chiropractors were instructed to have equal enthusiasm for both interventions. A path analysis was conducted to determine the effects of dose, patient expectations of treatment success, and DPE on LBP intensity (100-point scale) at the end of care (6 weeks) and primary endpoint (12 weeks). Direct, indirect, and total standardized effects (βtotal) were computed. Expectations and DPE were evaluated on Likert scales. The DPE was assessed as patient-rated perception of chiropractor enthusiasm, confidence, comfort with care, and time spent.

resultsThe DPE was successfully balanced across groups, as were baseline expectations. The principal finding was that the magnitude of the effects of DPE on LBP at 6 and 12 weeks (|β|total = 0.22 and 0.15, p < .05) were comparable to the effects of dose of manipulation at those times (|β|total = 0.11 and 0.12, p < .05). In addition, baseline expectations had no notable effect on follow-up LBP. Subsequent expectations were affected by LBP, DPE, and dose (p < .05).

conclusionsThe DPE can have a relatively important effect on outcomes in open-label randomized trials of treatment efficacy. Therefore, attempts should be made to balance the DPE across treatment groups and report degree of success in study publications. We balanced the DPE across groups with minimal training of treatment providers.

trial registrationClinicalTrials.gov NCT00376350.

Indexed as

ChiropracticHealth PersonnelManipulation, ChiropracticManipulation, SpinalPhysician-Patient RelationsAdultFemaleHumansLow Back PainMaleMassageResearch DesignTreatment Outcome

Identifiers

PMID24410959
PMCPMC3897979
OpenAlexW2058702147

What OpenQuestion holds

Textmetadata
LicenceCC BY
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.