The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis

Phase 4

Completed

• Conditions: Physical Therapy; Dextrose Prolotherapy Injection; Knee Osteoarthritis
• Interventions: Combination Product: conventional physical therapy; Drug: Dextrose prolotherapy injection

• Registration Number: NCT04958213
• Lead Sponsor: Mustafa Kemal University

Brief Summary

Osteoarthritis is a degenerative joint disease characterized by erosion of the articular cartilage, bone hypertrophy at the margins of the joint, subchondral sclerosis, and some biochemical and morphological changes in the synovial membrane and joint capsule. It is the most common joint disease that causes serious morbidity and its prevalence increases with age. It is known that there is a decrease in the muscle strength around the knee in knee osteoarthritis, which creates difficulties in daily living activities.

Prolotherapy is a regenerative treatment method in the treatment of chronic musculoskeletal pain, in which an irritating solution is injected, often hypertonic dextrose, into painful ligament and tendon attachments and adjacent joint spaces.

In this study, it is aimed to investigate the effect of dextrose prolotherapy application in and around the knee on pain, range of motion and knee flexor/extensor muscle strength.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-09-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-20
• Study First Submitted: 2021-06-30
• Status Verified: 2021-07
• Study First Submitted QC: 2021-07-09
• Last Update Submitted: 2021-07-09
• Study First Posted: 2021-07-12
• Last Update Posted: 2021-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

• Women aged 50-75 years
• 2-3 knee osteoarthritis by Kellgren Lawrence stage
• Knee pain and functional limitation

Exclusion Criteria

• Past knee surgery
• Intra articular knee injections in the last six months
• Symptomatic heart and lung disease
• Joint contracture
• History of malignant disease
• Bleeding disorder

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional physical therapy	conventional physical therapy	Conventional physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises) will be applied to this group for 4 weeks (20 sessions).
Dextrose prolotherapy treatment	Dextrose prolotherapy injection	This group will be treated with 15% dextrose prolotherapy around and inside the knee, 2 times with a two-week interval, and home exercise program (isometric and isotonic exercises).

Primary Outcome Measures

Name	Time	Method
Visual Analogue Scale (VAS)	VAS will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.	10 cm Visual Analogue Scale (0 best, 10 worst pain)
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	WOMAC will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.	A 24-item scale that assesses pain, stiffness, and physical function for knee osteoarthritis. The questions are evaluated by the participants between 0-4 points and the scale takes a value between 0-96 points in total.
Knee isokinetic power	This will be evaluated 3 times before treatment, 1 and 3 months after treatment. Afterwards, the changes between the pre-treatment and 1st month values and the pre-treatment and 3rd month values will be examined.	Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.

Trial Locations

Locations (1)

Hatay Mustafa Kemal University Faculty of Medicine; 🇹🇷 Hatay, Turkey