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

• Sponsor: Mustafa Kemal University (Other)
• Overall Status: Completed
• CT.gov ID: NCT04958213
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Actual Duration (Months): 9.6
• Patients Per Site Per Month: 6.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Knee Osteoarthritis; Dextrose Prolotherapy Injection; Physical Therapy	Drug: Dextrose prolotherapy injection; Combination Product: conventional physical therapy	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Isokinetic Evaluation of the Efficacy of Dextrose Prolotherapy Treatment in Women With Knee Osteoarthritis.
• Actual Study Start Date: Sep 1, 2020
• Actual Primary Completion Date: Jun 1, 2021
• Actual Study Completion Date: Jun 20, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: 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).	Combination Product: conventional physical therapy; 4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).
Active Comparator: Dextrose prolotherapy treatment 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; 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.

Outcome Measures

Primary Outcome Measures

1. 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)

2. 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.

3. 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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 50 Years to 75 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Hatay Mustafa Kemal University Faculty of Medicine	Hatay		Turkey

Sponsors and Collaborators

• Mustafa Kemal University

Investigators

• Study Director: Halil Ogut, Dr., Hatay Mustafa Kemal University Faculty of Medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Kamil Mursit Yildiz, Research assistant, Mustafa Kemal University
• ClinicalTrials.gov Identifier: NCT04958213
• Other Study ID Numbers: MustafaKU-KOA-Prolo
• First Posted: Jul 12, 2021
• Last Update Posted: Jul 12, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No
• Additional relevant MeSH terms: Osteoarthritis; Osteoarthritis, Knee

Study Results

No Results Posted as of Jul 12, 2021