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

Knee Osteoarthritis Clinical Trial

Official title:

Isokinetic Evaluation of the Efficacy of Dextrose Prolotherapy Treatment in Women With Knee Osteoarthritis.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04958213
• Other study ID #: MustafaKU-KOA-Prolo
• Status: Completed
• Phase: Phase 4
• Start date: September 1, 2020
• Est. completion date: June 20, 2021

Study information

• Verified date: July 2021
• Source: Mustafa Kemal University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 20, 2021
• Est. primary completion date: June 1, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Knee Osteoarthritis
• Osteoarthritis
• Osteoarthritis, Knee
• Physical Therapy

Intervention

Drug:
• Dextrose prolotherapy injection
15% dextrose prolotherapy injection into the knee and 15% dextrose prolotherapy injection will be applied to the painful adhesions of the ligaments around the knee.

Combination Product:
• conventional physical therapy
4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University Faculty of Medicine	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

Farpour HR, Fereydooni F. Comparative effectiveness of intra-articular prolotherapy versus peri-articular prolotherapy on pain reduction and improving function in patients with knee osteoarthritis: A randomized clinical trial. Electron Physician. 2017 Nov — View Citation

Rabago D, Patterson JJ, Mundt M, Kijowski R, Grettie J, Segal NA, Zgierska A. Dextrose prolotherapy for knee osteoarthritis: a randomized controlled trial. Ann Fam Med. 2013 May-Jun;11(3):229-37. doi: 10.1370/afm.1504. Erratum in: Ann Fam Med. 2013 Sep-Oc — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	10 cm Visual Analogue Scale (0 best, 10 worst pain)	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.
Primary	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)	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.	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.
Primary	Knee isokinetic power	Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.	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.