Clinical trial NCT04958213: The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis
Official title: Isokinetic Evaluation of the Efficacy of Dextrose Prolotherapy Treatment in Women With Knee Osteoarthritis.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Knee Osteoarthritis
Dextrose Prolotherapy Injection
Physical Therapy
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2021-07-12
Enrollment: 60
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 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.
measure: Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
timeFrame: 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.
measure: Knee isokinetic power
timeFrame: 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.
Secondary outcomes:
Other outcomes:
Locations:
city: Hatay
country: Turkey
facility: Hatay Mustafa Kemal University Faculty of Medicine
Study officials:
affiliation: Hatay Mustafa Kemal University Faculty of Medicine
name: Halil Ogut, Dr.
role: STUDY_DIRECTOR
References:
citation: 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.
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.