HDP vs NS Intra-articular Injection Among KOA With Obese Patient

NCT05966948 | Completed

• 1 other identifier: RSUHajiJaTimProv
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized controlled trial study was to compare the effect of intra-articular injection of Hypertonic Dextrose Prolotherapy (HDP) with Normal Saline (NS) in the clinical improvement of knee osteoarthritis (KOA) patients with comorbid obesity. The main questions to be answered are:

• How does the effect of HDP versus NS intra-articular injection compare to the numerical rating score (NRS) in obese KOA patients?
• How does the effect of HDP versus NS intra-articular injection compare to scores of The Western Ontario and McMaster Universities Arthritis Index (WOMAC) in obese KOA patients?
• How does the effect of HDP versus NS intra-articular injection compare to the thickness of the femoral cartilage in obese KOA patients? Participants who meet the inclusion and exclusion criteria will be randomized based on the order of the outpatient department each day, with odd numbers as the HDP intervention group and even numbers as NS. They received ultrasound-guided intra-articular injections on day 1 and day 30. Researchers will compare HDP versus NS groups to see which group improves NRS, WOMAC, and femoral cartilage thickness.

Conditions

Knee Osteoarthritis; Obesity

Keywords

knee osteoarthritis; obesity

Outcome Measures

Primary Outcomes (1)

• Numeric Rating Scale

  A numerical rating scale (NRS) requires the patient to rate their pain on a defined scale. We classified from 0 to 10, where 0 is no pain and 10 is the worst pain.

  Before intervention, day 1, and day 30 after intervention

Secondary Outcomes (2)

• WOMAC Score

  Before intervention, day 1, and day 30 after intervention

• Femoral Cartilage Thickness

  Before intervention, day 1, and day 30 after intervention

Study Arms (2)

Hypertonic Dextrose Prolotherapy

EXPERIMENTAL

This group received a Hypertonic dextrose intra articular is 25%, while extra articular 20% injection on day 1 and day 30 with same dose.

Drug: Dextrose Solution

Normal Saline

PLACEBO COMPARATOR

This group received Normal Saline injection on day 1 and day 30.

Drug: Normal Saline

Interventions

Dextrose Solution DRUG

Prolotherapy is a regenerative tissue therapy that is considered efficacious for reducing the symptoms and morbidity of Knee Osteoarthritis (KOA) using hypertonic dextrose as an injectable substance. Treatment will be given two times, on day 1st and 30th day.

Also known as: Dextrose Injection

Hypertonic Dextrose Prolotherapy

Normal Saline DRUG

Normal Saline will be intra-articular injected and given two times, on day 1st and 30th day.

Also known as: Normal Saline Injection

Normal Saline

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient was diagnosed with knee osteoarthritis (KOA).
• Patient was diagnosed with obesity.

You may not qualify if:

• Patient with a history of knee trauma.
• Patient with a history of knee surgery.
• Patient with a history of intra-articular injection before.

Sponsors & Collaborators

• Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia: lead

Study Sites (1)

Rumah Sakit Umum Daerah Haji Provinsi Jawa Timur, Indonesia

Surabaya, East Java, Indonesia

Location

Related Publications (10)

• Cortez VS, Moraes WA, Taba JV, Condi A, Suzuki MO, Nascimento FSD, Pipek LZ, Mattos VC, Torsani MB, Meyer A, Hsing WT, Iuamoto LR. Comparing dextrose prolotherapy with other substances in knee osteoarthritis pain relief: A systematic review. Clinics (Sao Paulo). 2022 May 17;77:100037. doi: 10.1016/j.clinsp.2022.100037. eCollection 2022.

  PMID: 35594623 BACKGROUND

• Topol GA, Pestalardo IG, Reeves KD, Elias F, Steinmetz NJ, Cheng AL, Rabago D. Dextrose Prolotherapy for Symptomatic Grade IV Knee Osteoarthritis: A Pilot Study of Early and Longer-Term Analgesia and Pain-Specific Cytokine Concentrations. Clin Pract. 2022 Nov 14;12(6):926-938. doi: 10.3390/clinpract12060097.

  PMID: 36412676 BACKGROUND

• Yu T, Yan S, Chi Z, Zhu D, Cheng P, Li H, Qin S, Zhong G, Ouyang X, Chen R, Jiao L. Comparative efficacy and safety of injection therapies for knee osteoarthritis: A protocol for systematic review and Bayesian network meta analysis. Medicine (Baltimore). 2020 Nov 20;99(47):e22943. doi: 10.1097/MD.0000000000022943.

  PMID: 33217798 BACKGROUND

• Sit RWS, Wu RWK, Rabago D, Reeves KD, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of Intra-Articular Hypertonic Dextrose (Prolotherapy) for Knee Osteoarthritis: A Randomized Controlled Trial. Ann Fam Med. 2020 May;18(3):235-242. doi: 10.1370/afm.2520.

  PMID: 32393559 BACKGROUND

• Pane RV, Setiyaningsih R, Widodo G, Al Hajiri AZZ, Salsabil JR. Femoral Cartilage Thickness in Knee Osteoarthritis Patients and Healthy Adults: An Ultrasound Measurement Comparison. ScientificWorldJournal. 2023 Feb 17;2023:3942802. doi: 10.1155/2023/3942802. eCollection 2023.

  PMID: 36845755 BACKGROUND

• Akcay S, Gurel Kandemir N, Kaya T, Dogan N, Eren M. Dextrose Prolotherapy Versus Normal Saline Injection for the Treatment of Lateral Epicondylopathy: A Randomized Controlled Trial. J Altern Complement Med. 2020 Dec;26(12):1159-1168. doi: 10.1089/acm.2020.0286. Epub 2020 Sep 28.

  PMID: 32990454 BACKGROUND

• Sit RWS, Wu RWK, Reeves KD, Rabago D, Chan DCC, Yip BHK, Chung VCH, Wong SYS. Efficacy of intra-articular hypertonic dextrose prolotherapy versus normal saline for knee osteoarthritis: a protocol for a triple-blinded randomized controlled trial. BMC Complement Altern Med. 2018 May 15;18(1):157. doi: 10.1186/s12906-018-2226-5.

  PMID: 29764447 BACKGROUND

• Wee TC, Neo EJR, Tan YL. Dextrose prolotherapy in knee osteoarthritis: A systematic review and meta-analysis. J Clin Orthop Trauma. 2021 May 20;19:108-117. doi: 10.1016/j.jcot.2021.05.015. eCollection 2021 Aug.

  PMID: 34046305 BACKGROUND

• Chen YW, Lin YN, Chen HC, Liou TH, Liao CD, Huang SW. Effectiveness, Compliance, and Safety of Dextrose Prolotherapy for Knee Osteoarthritis: A Meta-Analysis and Metaregression of Randomized Controlled Trials. Clin Rehabil. 2022 Jun;36(6):740-752. doi: 10.1177/02692155221086213. Epub 2022 Mar 8.

  PMID: 35257594 BACKGROUND

• Arias-Vazquez PI, Tovilla-Zarate CA, Legorreta-Ramirez BG, Burad Fonz W, Magana-Ricardez D, Gonzalez-Castro TB, Juarez-Rojop IE, Lopez-Narvaez ML. Prolotherapy for knee osteoarthritis using hypertonic dextrose vs other interventional treatments: systematic review of clinical trials. Adv Rheumatol. 2019 Aug 19;59(1):39. doi: 10.1186/s42358-019-0083-7.

  PMID: 31426856 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee; Obesity

Interventions

Glucose; Saline Solution

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Rita Vivera Pane, MD, PhD

  Universitas Nahdlatul Ulama Surabaya

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants who met the eligibility of the study who were on outpatient treatment on that day were randomized in order of queue, odd numbers as the intervention group and even numbers as the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This study involves two arms assigned randomly for receiving different treatment. One arm for Hypertonic Dextrose Prolotherapy as intervention group and Normal Saline as control group.

Study Record Dates

• First Submitted: July 11, 2023
• First Posted: August 1, 2023
• Study Start: May 1, 2023
• Primary Completion: September 30, 2023
• Study Completion: October 1, 2023
• Last Updated: October 18, 2023

Record last verified: 2023-10

Locations

ID (1)