Examining the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Knee Pain

NCT06345222 | Completed

• 1 other identifier: GETAT 23/05
• Study Type: interventional
• Target: 65
• Locations: 1 country
• Sites: 1

Brief Summary

92 patients with a diagnosis of primary knee pain of unknown cause followed at the family medicine outpatient clinic and who met our exclusion criteria were invited to the study. When creating patient list, the examination of patients, interviews with patients, as well as their medical records and examinations were used. Patients were divided into two groups: prolotherapy (n=46) and control group (n=46) by simple randomization method. However, when the study started, 32 people in the prolotherapy group and 33 people in the control group of these patients participated in the study. Prior to the research, detailed information was provided about the research in the experimental and control groups and signed consent was obtained from all participants that they volunteered to participate in the research. 5% dectrose was applied to the prolotherapy group by injection method to the pain area. In the control group, existing medical treatments were continued and no injection procedure was performed. Before the research, all participants were evaluated with Case Report Form, Visual Analog Scale (VAS) and Quality of Life Scale Short Form (SF-36). The cases in the experimental and control groups were re-evaluated with the VAS and SF-36 scales at the first month.

Conditions

The Aim of This Research is to Investigate the Effect of Prolotherapy on Quality of Life and Painkiller Use in Patients With Chronic Knee Pain

Outcome Measures

Primary Outcomes (2)

• change in knee pain with prolotherapy application

  Visual Analog Scale (VAS) scores determines pain relief. VAS scale use numbers from 0 to 10. A score of 0 means no pain, and 10 means the worst pain you have ever felt.

  1 month

• change in quality of life

  The Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health.SF-36 Scale scores determines change in quality of life. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.

  1 month

Study Arms (2)

Prolotherapy

EXPERIMENTAL

Patients to whom prolotherapy treatment applied (n=32).

Procedure: Prolotherapy

Control

OTHER

Patients to whom no prolotherapy applied. No intervention with their treatment (n=33).

Procedure: Prolotherapy

Interventions

Prolotherapy PROCEDURE

The "Modified Prolotherapy" technique was applied in the study and 0.5cc 5% Dextrose injection was applied per injection to the tendon entesis and/or tendon of the patient's non-rheumatic chronic, myoskeletal knee-induced, pain-inducing sensation. The follow-up period was determined as 1 month after the last injection. The ligaments to be injected within the scope of the research (context knee pain) were determined as Lateral Collateral Ligament (LCL), AnteroLateral Collateral Ligament (ALL), Medial Collateral Ligament (MCL), Pes Anserius and Patellar Ligament.

Control; Prolotherapy

Eligibility Criteria

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

You may qualify if:

• patients who suffer from primary knee osteoarthritis

You may not qualify if:

• Inflammatory knee pain
• Cellulitis
• Septic arthritis
• Local abscess
• Bleeding disorders
• Patient on anticoagulant medication
• Patients allergic to dextrose
• Diabetes Mellitus
• breathing problems
• Electrolyte imbalance
• Kidney or liver disease

Sponsors & Collaborators

• Bursa Yuksek Ihtisas Training and Research Hospital: lead

Study Sites (1)

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Türkiye, 16310, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Prolotherapy

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics

Study Officials

• Hakan Demirci, Professor

  Bursa Yuksek Ihtisas Training and Research Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: Case control study

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 3, 2024
• Study Start: May 1, 2023
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: April 4, 2024

Record last verified: 2024-04

Locations

TU (1)