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




Poster session 2


Monday 17 September 2018 - 12:30 to 14:00

All authors in correct order:

Lopes L1, Mazzei LG1, Bergamaschi CDC1, Barberato-Filho S1, Moura MDG1, Silva MT2
1 University of Sorocaba, Brazil
2 University of Sorocaba, Brazil
Presenting author and contact person

Presenting author:

Luciane Lopes

Contact person:

Abstract text
Backgound: Acupuncture is one of the therapeutic resources for managing chronic pain. Given the variability of outcome measures in controlled randomised clinical trials on non-oncologic chronic pain (CRCT-NOCP), the Initiative in Methods, Measurements and Pain Assessment in Clinical Trials (IMMPACT) recommends four main domains to be covered in evaluating the effectiveness of treatments for chronic pain.
Objectives: To 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.
Methods: We performed a systematic search for eligible studies in specific databases with a defined strategy. Eligible studies included CRCT with ≥ 100 NOCP patients to be treated with acupuncture or control (sham acupuncture or no acupuncture). The measured outcomes were: the presence of outcome domains recommended by IMMPACT; reported by the patient or clinician; tools used; and features of the studies. We conducted regression analyses to explore factors that may be associated with IMMPACT-recommended outcome domains.
Results: Of the 1386 articles we found, we included 24 in the analysis, mostly published in Germany. Of the included studies, 22 were published by 2004, and none referred to IMMPACT recommendations. The pain outcome was evaluated in 23 studies, where 34% adopted a recommended evaluation tool. The source of information of pain outcome was reported by patients in 50% of the studies. Recently published trials were more likely to report pain outcomes using recommended evaluation tools. Although most of them presented low risk of bias, many patient-important outcome domains remained unreported by over 70% of all trials evaluating the effects of acupuncture in CRCT-NOCP.
Conclusions: The trials included showed high variability in outcome measures, and even more in instruments adopted for measurement, which can lead to inaccurate estimates of the effects of treatment when pooled in meta-analyses.
Patient or healthcare consumer involvement: The use of IMMPACT recommendations in CRCT-NOCP allows for greater transparency in decisions regarding the use of acupuncture as an alternative and considering the patient's report in the evaluation of outcomes reduces reduces the interference of interpretation and judgment by the clinician.

Relevance to patients and consumers: 

The Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) was create to establish a standard set of patient-important outcome domains to guide the reporting of randomized controlled trials. Without consistent and more complete reporting of the outcomes that patients consider most important in randomized controlled trials for chronic non-oncologic pain, trialists/reviewist will be unable to fully convey the effects of a given treatment. Patient/consumer partners did not help me reach this statement