The Intersection of Massage Practice and Research: Community Massage Therapists as Research Personnel on an NIH-funded Effectiveness Study

Introduction: Few NIH funded studies give community massage therapists the opportunity to become study personnel. A recent NIH/NCCAMfunded study investigating chronic low back pain (CLBP) recruited, trained, and utilized community massage practitioners (CMPs) as study personnel. This study’s aim was to determine whether health-related outcomes for CLBP improve when patients are referred from primary care to select CAM modalities including massage therapy (MT). The purpose of this paper is to report the results of the study’s three massage practice-driven study objectives which were to: 1) identify challenges and solutions to recruiting and retaining ample CMPs, 2) develop a practice-informed protocol reflecting real-world MT, and 3) determine the extent to which CMPs comply with rigorous research methodology in their clinical practices as study personnel.Methods: Eligible CMPs in urban and rural Kentucky counties were identified through licensure board records, professional organizations, and personal contact opportunities. Interested CMPs completed 6 CE hours of research and Human Subjects Protection training and agreed to comply with a study protocol reflecting MT as practiced. Once trained, study CMPs were matched with study participants to provide and document up to 10 MT sessions per participant.Results: Utilizing prominent MT community members proved invaluable to CMP recruitment and protocol development. CMP recruitment challenges included mixed interest, low number of available rural CMPs, busy clinic schedules, and compensation. Ethics CE credits were offered to encourage CMP interest. A total of 28 Kentucky licensed massage therapists with 5–32 years of experience completed study training. A total of 127 CLBP patients consented to participate (n = 104 for MT). Twenty-five CMPs were assigned CLBP patients and provided 1–10 treatments for 94 study participants. Treatment documentation was provided by CMPs for 97% of treatments provided.Conclusions: When recruitment, retention, and protocol compliance challenges are met, CMPs are valuable study personnel for practice-based research reflecting real-world MT practice

Sparsentan in patients with IgA nephropathy: a prespecified interim analysis from a randomised, double-blind, active-controlled clinical trial

Background: Sparsentan is a novel, non-immunosuppressive, single-molecule, dual endothelin and angiotensin receptor antagonist being examined in an ongoing phase 3 trial in adults with IgA nephropathy. We report the prespecified interim analysis of the primary proteinuria efficacy endpoint, and safety. Methods: PROTECT is an international, randomised, double-blind, active-controlled study, being conducted in 134 clinical practice sites in 18 countries. The study examines sparsentan versus irbesartan in adults (aged ≥18 years) with biopsy-proven IgA nephropathy and proteinuria of 1·0 g/day or higher despite maximised renin-angiotensin system inhibitor treatment for at least 12 weeks. Participants were randomly assigned in a 1:1 ratio to receive sparsentan 400 mg once daily or irbesartan 300 mg once daily, stratified by estimated glomerular filtration rate at screening (30 to 1·75 g/day). The primary efficacy endpoint was change from baseline to week 36 in urine protein-creatinine ratio based on a 24-h urine sample, assessed using mixed model repeated measures. Treatment-emergent adverse events (TEAEs) were safety endpoints. All endpoints were examined in all participants who received at least one dose of randomised treatment. The study is ongoing and is registered with ClinicalTrials.gov, NCT03762850. Findings: Between Dec 20, 2018, and May 26, 2021, 404 participants were randomly assigned to sparsentan (n=202) or irbesartan (n=202) and received treatment. At week 36, the geometric least squares mean percent change from baseline in urine protein-creatinine ratio was statistically significantly greater in the sparsentan group (-49·8%) than the irbesartan group (-15·1%), resulting in a between-group relative reduction of 41% (least squares mean ratio=0·59; 95% CI 0·51-0·69; p<0·0001). TEAEs with sparsentan were similar to irbesartan. There were no cases of severe oedema, heart failure, hepatotoxicity, or oedema-related discontinuations. Bodyweight changes from baseline were not different between the sparsentan and irbesartan groups. Interpretation: Once-daily treatment with sparsentan produced meaningful reduction in proteinuria compared with irbesartan in adults with IgA nephropathy. Safety of sparsentan was similar to irbesartan. Future analyses after completion of the 2-year double-blind period will show whether these beneficial effects translate into a long-term nephroprotective potential of sparsentan. Funding: Travere Therapeutics