Article Figures & Data
Figures
- Figure 1
Study flowchart.
- Figure 2
Change in observed WOMAC pain score from baseline to 52 weeks follow up.
WOMAC = Western Ontario McMaster University Osteoarthritis Index.
Tables
- Table 1
Baseline Demographic and Clinical Characteristics of the Dextrose and Normal Saline Injection Groupsa
Characteristic Total
(n = 76)DPT
(n = 38)NS
(n = 38)Age, y 63.2 (5.5) 62.8 (5.8) 63.7 (5.2) Body mass index, No. (%) 24.5 (3.3) 24.0 (3.4) 25.0 (3.3) Normal (18.5–22.9) 24 (31.6) 15 (39.5) 9 (23.7) Underweight (<18.5) 1 (1.3) 1 (2.6) 0 (0.0) Overweight (23–24.9) 16 (21.1) 6 (15.8) 10 (26.3) Obese (≥25) 35 (46.1) 16 (42.1) 19 (50.0) Sex, No. (%) Male 22 (28.9) 11 (28.9) 11 (28.9) Female 54 (71.1) 27 (71.1) 27 (71.1) Duration of knee pain, y 8.9 (8.0) 9.7 (9.8) 8.2 (5.7) Previous knee interventions, No. (%) 48 (63.2) 27 (71.1) 21 (55.3) Knee exercise 6 (7.9) 6 (15.8) 0 (0.0) Physiotherapy 33 (43.4) 17 (44.7) 16 (42.1) Traditional Chinese medicine 28 (36.8) 16 (42.1) 12 (31.6) Other 4 (5.3) 4 (10.5) 0 (0.0) OA knee pain intensity (VAS: 0–100) 61.6 (20.2) 63.1 (21.2) 60.1 (19.2) Kellgren-Lawrence grading, No. (%) 0 - Normal or 1 - Doubtful JSN and possible osteophytic lipping 13 (17.1) 8 (21.1) 5 (13.2) 2 - Definite osteophytes and possible JSN on anteroposterior weight-bearing radiograph 28 (36.8) 12 (31.6) 16 (42.1) 3 - Multiple osteophytes, definite JSN, sclerosis, possible bony deformity 29 (38.2) 16 (42.1) 13 (34.2) 4 - Large osteophytes, marked JSN, severe sclerosis and definite bony deformity 6 (7.9) 2 (5.3) 4 (10.5) IPAQ (Met), median (IQR) 2,620 (2,779) 2,991 (2,626) 2,333 (2,066) Inactive, No. (%) 4 (5.3) 1 (2.6) 3 (7.9) Minimally active, No. (%) 40 (52.6) 16 (42.1) 24 (63.2) Undertakes HEPA, No. (%) 32 (42.1) 21 (55.3) 11 (28.9) WOMAC (pain) 47.0 (21.9) 49.9 (23.1) 44.0 (20.4) WOMAC (stiffness) 47.4 (26.5) 48.0 (26.3) 46.8 (27.0) WOMAC (function) 47.5 (21.9) 49.0 (21.8) 45.9 (22.1) WOMAC (composite) 47.4 (21.4) 49.1 (21.8) 45.6 (21.2) Timed up and go 12.6 (5.8) 12.6 (7.1) 12.5 (4.3) 30-second chair stand 8.5 (2.8) 8.6 (2.6) 8.5 (3.0) 40-m fast-paced walk 42.4 (13.7) 42.1 (12.9) 42.7 (14.6) EuroQol-5D VAS 67.7 (15.6) 70.1 (13.5) 65.3 (17.3) EuroQol-5D index score 0.564 (0.305) 0.569 (0.295) 0.558 (0.318) DPT = dextrose prolotherapy; HEPA = health-enhancing physical activity; IPAQ = International Physical Activity Questionnaire; IQR = interquartile range; JSN = joint space narrowing; Met = metabolic equivalent; NS = normal saline; OA = osteoarthritis; SD = standard deviation; VAS = visual analogue scale; WOMAC = Western Ontario McMaster University Osteoarthritis Index.
↵a The data are shown as the mean (SD) unless otherwise indicated.
Measurement 16 Weeks 26 Weeks 52 Weeks Overall Trendb Primary outcome WOMAC (pain) −4.81 (−13.47 to 3.85) −9.73 (−18.39 to −1.07)c −10.34 (−19.20 to −1.49)c −8.26 (−14.83 to −1.69)c Secondary outcomes WOMAC (stiffness) −0.74 (−11.06 to 9.58) −5.79 (−16.11 to 4.53) −8.01 (−18.56 to 2.54) −4.73 (−12.61 to 3.15) WOMAC (function) −4.50 (−12.49 to 3.49) −6.71 (−14.70 to 1.28) −9.55 (−17.72 to −1.39)c −6.84 (−12.99 to −0.69)c WOMAC (composite) −4.33 (−12.27 to 3.62) −7.34 (−15.28 to 0.61) −9.65 (−17.77 to −1.53)c −7.03 (−13.14 to −0.92)c Pain intensity (VAS) −3.70 (−13.83 to 6.43) −6.73 (−16.86 to 3.40) −10.98 (−21.36 to −0.61)c −7.02 (−14.50 to 0.46) Timed up and go −1.13 (−2.74 to 0.49) −1.73 (−3.34 to −0.12)c −0.3 (−2.38 to 0.92) −1.22 (−2.46 to 0.02) 30-second chair stand 0.02 (−0.96 to 0.99) 0.81 (−0.17 to 1.78) 0.03 (−0.96 to 1.03) 0.30 (−0.48 to 1.08) 40-m fast-paced walk −1.07 (−4.29 to 2.16) −2.62 (−5.84 to 0.61) −1.78 (−5.07 to 1.51) −1.84 (−4.40 to 0.71) EuroQol-5D VAS … 4.26 (−2.83 to 11.36) 8.64 (1.36 to 15.92)c 6.36 (0.74-11.98)c EuroQol-5D index score … 0.10 (−0.004 to 0.21) 0.08 (−0.02 to 0.19) 0.09 (0.01-0.18)c VAS = visual analogue scale; WOMAC = Western Ontario McMaster University Osteoarthritis Index.
↵a The data are shown as interaction term between treatment variable and time (95% CI). Normal saline group as the reference group.
↵b Overall treatment effect is examined with time indicator 0 for baseline and 1 for follow-up visits.
↵c P value <.05.
Supplemental Appendixes
Supplemental Appendixes
Files in this Data Supplement:
- Supplemental data: Appendixes - PDF file
The Article in Brief
Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial
, and colleagues
Background Knee osteoarthritis is ubiquitous in primary care, leading to pain, disability, and substantial individual and societal costs. Conservative care is limited, and total knee replacement is effective, but is costly and carries operative risk. Identifying safe and effective non surgical therapy remains a high priority in clinical practice and orthopedic research.
What This Study Found A randomized controlled trial conducted by a research team at a primary care clinic at the Chinese University of Hong Kong indicates that intra-articular-only injection therapy with hypertonic dextrose is safe and effective for alleviating symptoms of knee osteoarthritis. Over 52 weeks of treatment, the study followed 76 patients who were between 45 and 75 years old who had been diagnosed with knee osteoarthritis and who suffered moderate to severe chronic knee pain for at least three months. One group of 38 patients received the hypertonic dextrose injection therapy, while the other had the same therapy only using normal saline. While both groups reported some improvement, the hypertonic dextrose group reported more significant reductions in pain by the conclusion of the study.
Implications
- Intra-articular dextrose prolotherapy injections reduced pain, improved function and quality of life in patients with KOA compared with blinded saline injections. The procedure is straightforward and safe; the adherence and satisfaction were high. The researchers note that longer-term follow-up, direct comparison with other injection therapies, and cost-effective analysis are all needed.
