Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: a protocol for a methodological survey

Abstract

IntroductionPain is one of the most common and most debilitating complaints among patients. It affects the individual, their relationship with friends and family, their ability to function at work, and their sociability. Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologicchronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends six domains to be covered in evaluating the effectiveness of treatments for chronic pain.ObjectiveTo check whether the methodological quality of outcome reporting in published trials has used IMMPACT recommendations in measuring CRCT-NOCP outcomes when acupuncture was used as a treatment.MethodThis is a methodological study. We will systematically search for eligible studies in specific databases with a defined strategy. We will use the MeSHterms of ‘acupuncture’, ‘chronic pain’ and similar terms, without restrictions on idiom. Eligible studies will include those which are randomised and chose NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture), recruited after September 2004, with ≥100 patients. The measured outcomes are to be the presence of outcome domains recommended by IMMPACT, domains reported by the patient or clinician, tools used to measure such domains, as well as other features of the studies. We shall conduct a regression analysis to explore factors which can be associated with the presence of outcome domains according to IMMPACT recommendations.Ethics and disseminationThis survey will be submitted for presentation at congresses and for publication in a scientific journal. The findings obtained in this study will allow us to measure the quality of the evidence and provide greater transparency in decisions regarding the use of acupuncture as a viable alternative to managing chronic pain.

Use of IMMPACT domains in clinical trials of acupuncture for chronic pain: A methodological survey

“…The PICO question of this study is: Did the RCT with NOCP patients treated with acupuncture compared to sham or non-acupuncture the measures results follow recommended by IMMPACT? The study protocol was published in the journal BMJ Open with identification number DOI: 10.1136/bmjopen-2016-014904 [17].…”

“…RCTs, whose number of patients was equal to or greater than 100. The date of recruitment of the first participant was not an eligibility criterion, differing from what has been stated in our protocol already published, to broaden the capture of studies, as described in detail previously [17].…”