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

NCT04958213 | Completed Phase 4

• 1 other identifier: MustafaKU-KOA-Prolo
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis; Dextrose Prolotherapy Injection; Physical Therapy

Outcome Measures

Primary Outcomes (3)

• 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.

• 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.

• 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.

Study Arms (2)

Conventional physical therapy

OTHER

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).

Combination Product: conventional physical therapy

Dextrose prolotherapy treatment

ACTIVE COMPARATOR

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).

Drug: Dextrose prolotherapy injection

Interventions

Dextrose prolotherapy injection DRUG

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.

Dextrose prolotherapy treatment

conventional physical therapy COMBINATION_PRODUCT

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

Conventional physical therapy

Eligibility Criteria

• Age: 50 Years - 75 Years
• Gender Eligibility Details: Knee osteoarthritis is more common in women.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mustafa Kemal University: lead

Study Sites (1)

Hatay Mustafa Kemal University Faculty of Medicine

Hatay, Turkey (Türkiye)

Location

Related 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 25;9(11):5663-5669. doi: 10.19082/5663. eCollection 2017 Nov.

  PMID: 29403602 RESULT

• 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.

  PMID: 23690322 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Study Officials

• Halil Ogut, Dr.

  Mustafa Kemal University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research assistant

Study Record Dates

• First Submitted: June 30, 2021
• First Posted: July 12, 2021
• Study Start: September 1, 2020
• Primary Completion: June 1, 2021
• Study Completion: June 20, 2021
• Last Updated: July 12, 2021

Record last verified: 2021-07

Locations

TU (1)