NCT05537077

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
128

participants targeted

Target at P75+ for not_applicable knee-osteoarthritis

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2021

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

September 3, 2022

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 13, 2022

Completed
Last Updated

September 13, 2022

Status Verified

September 1, 2022

Enrollment Period

1 year

First QC Date

September 3, 2022

Last Update Submit

September 8, 2022

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (4)

  • Change in Visual Analog Scale (VAS)

    VAS is a scale used to evaluate pain severity. Pain severity is evaluated between 0 and 10. A high score indicates a bad result.

    Pre-intervention, sixth week, twelfth week.

  • Change in Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC)

    WOMAC; It consists of three subcategories: pain, stiffness, and physical function difficulty. A score of 20 for pain, 8 for stiffness, 68 for physical function difficulty, and a total of 96 points can be obtained. An increase in the score is interpreted as more pain, stiffness and loss of function.

    Pre-intervention, sixth week, twelfth week.

  • Change in Knee Joint Range of Motion

    Knee flexion in the prone position and knee extension in the supine position were measured actively and passively with a goniometer.

    Pre-intervention, sixth week, twelfth week.

  • Change in The Timed "Up & Go" Test

    In this test, balance, walking speed and functional capacity are evaluated. Patients who complete the test in less than 10 seconds are considered independent.

    Pre-intervention, sixth week, twelfth week.

Secondary Outcomes (1)

  • Change in Short Form 36 (SF-36)

    Pre-intervention, twelfth week.

Study Arms (4)

Group 1

ACTIVE COMPARATOR

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

Other: ProlotherapyOther: Home based exercise programOther: Hotpack therapy

Group 2

ACTIVE COMPARATOR

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

Other: ProlotherapyOther: Home based exercise programOther: Hotpack therapy

Group 3

ACTIVE COMPARATOR

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

Other: ProlotherapyOther: Home based exercise programOther: Hotpack therapy

Group 4

ACTIVE COMPARATOR

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

Other: Home based exercise programOther: Hotpack therapy

Interventions

ProlotherapyOTHER

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.

Group 1Group 2Group 3
Home based exercise programOTHER

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

Group 1Group 2Group 3Group 4
Hotpack therapyOTHER

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

Group 1Group 2Group 3Group 4

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ataturk University Faculty of Medicine

Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (3)

  • 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: 34046305BACKGROUND

  • 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.

    PMID: 32223554BACKGROUND

  • 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.

    PMID: 37540383DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Prolotherapy

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Complementary TherapiesTherapeutics

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

September 3, 2022

First Posted

September 13, 2022

Study Start

March 1, 2020

Primary Completion

March 1, 2021

Study Completion

March 1, 2021

Last Updated

September 13, 2022

Record last verified: 2022-09

Locations

TU(1)