Evidence map›Paper›PMID 26044576›Full record

Trial reportTrials2015

Development of an attention-touch control for manual cervical distraction: a pilot randomized clinical trial for patients with neck pain.

M Ram Gudavalli, Stacie A Salsbury, Robert D Vining, Cynthia R Long, Lance Corber, Avinash G Patwardhan, Christine M Goertz

Registry-linked trialAbstract readComparative StudyRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01765751 (Cervical Distraction Minimal Intervention Development), which is not on this map. Cited by 8 papers.

0numbers the graph read from it
0cells of the map it votes in
8citing papers in PubMed
–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.

NCT01765751 nacompletednot on this map

Cervical Distraction Minimal Intervention Development: Translating From Basic to Clinical Studies

TypeinterventionalSponsorPalmer College of ChiropracticRan2013 to 2013Enrolled48ConditionsNeck Pain, Pain in Arm, UnspecifiedArmsManual Cervical Distraction
3 · Its place in the literature

Who cites it

8 citing papers in PubMed.

  1. Article
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  8. Review
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

7 authors.

M Ram GudavalliPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. gudavalli_r@palmer.edu.
Stacie A SalsburyPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. stacie.salsbury@palmer.edu.
Robert D ViningPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. robert.vining@palmer.edu.
Cynthia R LongPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. LONG_C@palmer.edu.
Lance CorberPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. CORBER_L@palmer.edu.
Avinash G PatwardhanMusculoskeletal Biomechanics Laboratory, Edward Hines Jr. VA Hospital, Hines, IL and Department of Orthopedic Surgery & Rehabilitation, Stritch School of Medicine, Loyola University Chicago, Chicago, IL, USA. apatwar@lumc.edu.
Christine M GoertzPalmer Center for Chiropractic Research, Palmer College of Chiropractic, 741 Brady Street, 52803, Davenport, IA, USA. christine.goertz@palmer.edu.

Funding

Developmental Center for Clinical and Translational Science in ChiropracticU19AT004663 · NCCIH · PALMER COLLEGE OF CHIROPRACTIC · PI GOERTZ, CHRISTINE MARIE · 2008 to 2013
$3.6M
RENOVATION OF PALMER CENTER FOR CHIROPRACTIC RESEARCHC06RR015433 · NCRR · PALMER COLLEGE OF CHIROPRACTIC · PI MEEKER, WILLIAM C · 2000 to 2000
$1.3M
NCCIH NIH HHS U19 AT004663NCRR NIH HHS C06 RR015433PHS HHS NCT01765751
6 · The paper itself

Abstract

backgroundManual cervical distraction (MCD) is a traction-based therapy performed with a manual contact over the cervical region producing repeating cycles while patients lie prone. This study evaluated a traction force-based minimal intervention for use as an attention-touch control in clinical trials of MCD for patients with chronic neck pain.

methodsWe conducted a mixed-methods, pilot randomized clinical trial in adults with chronic neck pain. Participants were allocated to three traction force ranges of MCD: low force/minimal intervention (0-20 N), medium force (21-50 N), or high force (51-100 N). Clinicians delivered five treatments over two weeks consisting of three sets of five cycles of MCD at the C5 vertebra and occiput. Traction forces were measured at each treatment. Patient-reported outcomes included a pain visual analogue scale (VAS), Neck Disability Index (NDI), Credibility and Expectancy Questionnaire (CEQ), and adverse effects. A qualitative interview evaluated treatment group allocation perceptions.

resultsWe randomized 48 participants, allocating an average of five each month. Forty-five participants completed the trial with three participants lost to follow-up. Most participants were women (65%) and white (92%) with a mean (SD) age of 46.8 (12.5) years. Mean traction force values were within the prescribed force ranges for each group at the C5 and occiput levels. Neck pain VAS demonstrated a benefit for high traction force MCD compared to the low force group [adjusted mean difference 15.6; 95% confidence interval (CI) 1.6 to 29.7]. Participants in the medium traction force group demonstrated improvements in NDI compared to the low force group (adjusted mean difference 3.0; 95% CI 0.1 to 5.9), as did participants in the high traction force group (adjusted mean difference 2.7; 95% CI -0.1 to 5.6). CEQ favored the high force group. Most low force participants correctly identified their treatment allocation in the qualitative interview. No serious adverse events were documented.

conclusionsThis pilot study demonstrated the feasibility of a clinical trial protocol and the utility of a traction-based, minimal intervention as an attention-touch control for future efficacy trials of MCD for patients with neck pain.

trial registrationClinicalTrials.gov NCT01765751 (Registration Date 30 May 2012).

Indexed as

AttentionTouch PerceptionAdultAgedBiomechanical PhenomenaCervical VertebraeDisability EvaluationEquipment DesignFemaleHumansInterviews as TopicIowaMaleManipulation, SpinalMiddle AgedNeck Pain

Identifiers

PMID26044576
PMCPMC4460764

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.