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

NCT ID: NCT06345222

Last Updated: 2024-04-04

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-05-01
• Study Completion Date: 2023-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Prolotherapy

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

Group Type: EXPERIMENTAL

Prolotherapy

Intervention Type: 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

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

Group Type: OTHER

Prolotherapy

Intervention Type: 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.

Interventions

Prolotherapy

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients who suffer from primary knee osteoarthritis

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bursa Yuksek Ihtisas Training and Research Hospital

OTHER_GOV

Sponsor Role: lead

Responsible Party

Hakan Demirci

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Hakan Demirci, Professor

Role: STUDY_CHAIR

Bursa Yuksek Ihtisas Training and Research Hospital

Locations

Bursa Yuksek Ihtisas Training and Research Hospital

Bursa, Türkiye, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

GETAT 23/05

Identifier Type: -

Identifier Source: org_study_id