Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial

Regina Wing Shan Sit,Vincent Chi Ho Chung,Benjamin Hon Kei Yip,Samuel Yeung Shan Wong,Ricky Wing Keung Wu,Dicken Cheong Chun Chan,Kenneth Dean Reeves,David Rabago

doi:10.1186/s12906-018-2226-5

Abstract

BackgroundKnee Osteoarthritis (KOA) is a very common condition with prevalence rising with age. It is a major contributor to global disability and has a large socioeconomic burden worldwide. Conservative therapies have marginal effectiveness, and surgery is reserved for severe symptomatic KOA. Dextrose Prolotherapy (DPT) is an evidence-based injection-based therapy for chronic musculoskeletal conditions including KOA. The standard “whole joint” injection method includes intra-articular injection and multiple extra-articular injections at soft tissue bony attachments. The procedure is painful and requires intensive procedural training often unavailable in conventional medical education, which potentially limits access. Intra-articular injection offers the possibility of a less painful, more accessible treatment. The aim of this project is to assess the clinical efficacy of intra-articular injection of DPT versus normal saline (NS) for KOA.MethodSeventy-six participants with KOA will be recruited from the community. We will conduct a single center, parallel group, superiority randomized controlled trial comparing DPT and NS injections, with blinding of physician, participants, outcome assessors and statisticians. Each group will receive injections at week 0, 4, 8 and 16. The primary outcome will be the Western Ontario McMaster University Osteoarthritis Index pain scale (WOMAC), and secondary outcomes include WOMAC composite score, the WOMAC function and stiffness subscale, the Visual Analogue Score of pain, objective physical function tests (the 30 s chair stand, 40- m fast paced walk test, the Timed up and go test) and the EuroQol-5D (EQ-5D). All outcomes will be evaluated at baseline, and 16, 26 and 52 weeks. All analyses will be conducted on an intention-to-treat basis using linear mixed regression models.DiscussionThis paper presents the rationale, design, method and operational aspects of the trial. The findings will determine whether IA DPT, an inexpensive and simple injection, is a safe and effective non-surgical option for KOA. The results can be translated directly to clinical practice, with potentially substantial impact to patient care.Trial registrationThe trial (ChiCTR-IPC-15006617) is registered under Chinese Clinical Trials Registry on 17th June 2015.

Highlights

Knee Osteoarthritis (KOA) is a very common condition with prevalence rising with age
The findings will determine whether IA Dextrose Prolotherapy (DPT), an inexpensive and simple injection, is a safe and effective non-surgical option for KOA
There is a compelling need to conduct a high quality randomized controlled trial (RCT) with rigorous study design to determine the clinical efficacy of a brief intervention, IA DPT for KOA

Summary

Introduction

Knee Osteoarthritis (KOA) is a very common condition with prevalence rising with age. Knee osteoarthritis (KOA) is a common chronic arthritis leading to joint pain and disability worldwide [1]. While exercise and weight reduction are effective in KOA, factors such as fatigue, accessibility and the arthritis itself have been identified as barriers for the actual participation [7]. Other conservative therapies such as physiotherapy, oral analgesic medications and complementary therapies such as acupuncture and herbal treatment have marginal effectiveness [8,9,10,11]. Total knee replacement (TKR) for advanced KOA is effective but costly [12].a safe and effective treatment option that complements the current conservative therapy remains a top priority in clinical practice and research [13, 14]

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