Different Concentrations of Dextrose Prolotherapy Treatment in Knee Osteoartritis

NCT ID: NCT05537077

Last Updated: 2022-09-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

128 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-03-01

Brief Summary

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In this study, the investigators aimed to compare the efficacy of %5, %10 and %20 concentration dextrose prolotherapy (DPT) treatments in patients with primary knee osteoarthritis (OA). In this prospective, randomized, controlled, single-blind study, 128 patients who met the inclusion criteria were recruited and divided into four groups. Thirty patients from each group completed the study. %5 DPT was applied to Group 1, %10 to Group 2, and %20 to Group 3 in combination with home exercise program and hotpack therapy. Group 4 was given home exercise program and hotpack therapy. Groups were evaluated with VAS (Visual Analog Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index), knee ROM (Range of Motion), and Timed up and go test (TUG) parameters. DPT groups were evaluated in terms of side effects.

Detailed Description

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Conditions

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Knee Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Group 1

%5 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 1.

Group Type ACTIVE_COMPARATOR

Prolotherapy

Intervention Type OTHER

DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.

Home based exercise program

Intervention Type OTHER

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Hotpack therapy

Intervention Type OTHER

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Group 2

%10 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 2.

Group Type ACTIVE_COMPARATOR

Prolotherapy

Intervention Type OTHER

DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.

Home based exercise program

Intervention Type OTHER

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Hotpack therapy

Intervention Type OTHER

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Group 3

%20 Dextrose prolotherapy, hotpack therapy and home based exercise program was applied to group 3.

Group Type ACTIVE_COMPARATOR

Prolotherapy

Intervention Type OTHER

DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.

Home based exercise program

Intervention Type OTHER

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Hotpack therapy

Intervention Type OTHER

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Group 4

Hotpack therapy and home based exercise program was applied to group 4.

Group Type ACTIVE_COMPARATOR

Home based exercise program

Intervention Type OTHER

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Hotpack therapy

Intervention Type OTHER

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Interventions

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Prolotherapy

DPT was applied as a total of 3 sessions at 0, 3 and 6 weeks. In each session, intra-articular 5 ml and periarticular 10 ml dextrose injections were administered to the knee. Periarticular injection was applied to 10 points as 1 ml in each region. The regions were determined as medial and lateral coronary ligaments, proximal and distal medial and lateral collateral ligaments, pes anserinus region, proximal and distal patellar tendon, quadriceps tendon attachment area.

Intervention Type OTHER

Home based exercise program

Knee ROM, isometric and isotonic quadriceps strengthening exercises were given as 2 sets of 10 repetitions per day for 12 weeks.

Intervention Type OTHER

Hotpack therapy

Hotpack treatment was applied for 20 minutes at 0, 3 and 6 weeks.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patients aged 40-70 years,
* Knee pain for more than three months,
* Diagnosed with primary knee OA according to ACR clinical/radiological diagnostic criteria and Kellgren-Lawrence stage II-III.

Exclusion Criteria

* Total knee replacement
* Rheumatological diseases, systemic infection, and malignancy
* Pregnancy or breastfeeding
* Taking a nonsteroidal anti-inflammatory drug (NSAID) in the last week, taking steroid drugs in the last month
* Undergoing anticoagulant or immunosuppressive therapy
* Knee injection in the last 6 months
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Turkish League Against Rheumatism

OTHER

Sponsor Role lead

Responsible Party

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Muhammet Uğur ÖZTÜRK

Medical Doctor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ataturk University Faculty of Medicine

Erzurum, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 34046305 (View on PubMed)

Sert AT, Sen EI, Esmaeilzadeh S, Ozcan E. The Effects of Dextrose Prolotherapy in Symptomatic Knee Osteoarthritis: A Randomized Controlled Study. J Altern Complement Med. 2020 May;26(5):409-417. doi: 10.1089/acm.2019.0335. Epub 2020 Mar 30.

Reference Type BACKGROUND
PMID: 32223554 (View on PubMed)

Ozturk MU, Baygutalp F. A comparative analysis of prolotherapy efficacy in patients with knee osteoarthritis across varied dextrose concentrations. Clin Rheumatol. 2023 Dec;42(12):3321-3331. doi: 10.1007/s10067-023-06723-4. Epub 2023 Aug 4.

Reference Type DERIVED
PMID: 37540383 (View on PubMed)

Other Identifiers

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TRASD-MUO-TEZ

Identifier Type: -

Identifier Source: org_study_id

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