Evidence map›Paper›PMID 28351829›Full record

ArticleJMIR research protocols2017

Innovations in the Management of Musculoskeletal Pain With Alpha-Lipoic Acid (IMPALA Trial): Study protocol for a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of Alpha-Lipoic Acid for the Treatment of Fibromyalgia Pain.

Ian Gilron, Dongsheng Tu, Ronald Holden, Tanveer Towheed, Dan Ziegler, Louie Wang, Roumen Milev, Christopher Gray

Open access · goldAbstract read
In one paragraph

Article in JMIR research protocols, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
0.9field-weighted citation impact, top 28% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

5 citing papers in PubMed, 7 citations in OpenAlex.

  1. Trial
  2. Review
  3. Review
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  5. 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

8 authors at 3 institutions in 2 countries.

Ian GilronQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0002-5293-8792
Dongsheng TuQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0003-4842-2184
Ronald HoldenQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0002-9070-2510
Tanveer TowheedQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0001-8738-9394
Dan ZieglerHeinrich Heine University, Dusseldorf, Germany.ORCID http://orcid.org/0000-0001-8956-3552
Louie WangQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0002-3190-6361
Roumen MilevQueen's University, Kingston, ON, Canada.ORCID http://orcid.org/0000-0001-6884-171X
Christopher GrayKingston General Hospital, Kingston, ON, Canada.ORCID http://orcid.org/0000-0002-5373-2964
Queen's University · CAHeinrich Heine University Düsseldorf · DEKingston General Hospital · CA

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundFibromyalgia is a common disorder characterized by chronic widespread pain, sleep disturbance, fatigue, depression, and cognitive dysfunction, resulting in substantial disability. As current analgesics provide incomplete relief and disabling side effects that aggravate fatigue and cognitive dysfunction, there is a need for new pain treatments with better efficacy and tolerability. Alpha-lipoic acid (ALA) is an antioxidant proven effective in painful diabetic neuropathy with minimal side effects.

objectiveWe hypothesize that this agent will provide benefits in fibromyalgia because of several similarities with neuropathic pain and also because it does not cause sedation, fatigue, or mental-slowing. To test this, we have designed a clinical trial that will assess pain, side effects, and other outcomes in participants with fibromyalgia.

methodsUsing a crossover design, 24 adults with fibromyalgia will be randomly allocated to 1 of the 2 sequences of ALA and placebo. Participants will take capsules containing ALA or placebo for 4 weeks followed by a 1-week washout followed by a second 4-week treatment and 1-week washout period. ALA (or matching placebo) capsules will be titrated to 1800 mg/day over each 4-week period. The primary outcome will be mean daily pain intensity (0-10) during week 4 of each period. Secondary outcomes, assessed during week 4 of each period, will include global improvement, adverse events, mood, and quality of life.

resultsThis trial was registered in the International Standard Randomized Controlled Trial registry March 15, 2016 (Number ISRCTN58259979), and it attained ethics approval on December 3, 2016 (Queen's University Health Sciences & Affiliated Teaching Hospitals Research Ethics Board protocol number ANAE-287-15). The recruitment started in February 2017.

conclusionsThis trial will provide evidence for the efficacy of ALA in fibromyalgia.

trial registrationInternational Standard Randomized Controlled Trial Number (ISRCTN): 58259979; www.isrctn.com/ISRCTN58259979 (Archived by WebCite at http://www.webcitation.org/6og9JdiyZ).

Indexed as

alpha-lipoic acidantioxidantsfibromyalgiapain

Identifiers

PMID28351829
PMCPMC5388826
OpenAlexW2602593591

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.