The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis, Dextrose Prolotherapy Injection, Physical Therapy
Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Dextrose prolotherapy injection
conventional physical therapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
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
Sites / Locations
- Hatay Mustafa Kemal University Faculty of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Active Comparator
Arm Label
Conventional physical therapy
Dextrose prolotherapy treatment
Arm Description
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).
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).
Outcomes
Primary Outcome Measures
Visual Analogue Scale (VAS)
10 cm Visual Analogue Scale (0 best, 10 worst pain)
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.
Knee isokinetic power
Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04958213
Brief Title
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
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
September 1, 2020 (Actual)
Primary Completion Date
June 1, 2021 (Actual)
Study Completion Date
June 20, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mustafa Kemal University
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis, Dextrose Prolotherapy Injection, Physical Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional physical therapy
Arm Type
Other
Arm Description
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).
Arm Title
Dextrose prolotherapy treatment
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Dextrose prolotherapy injection
Intervention Description
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.
Intervention Type
Combination Product
Intervention Name(s)
conventional physical therapy
Intervention Description
4 weeks (20 sessions) physical therapy (Hotpack, TENS and Ultrasound) and home exercise program (isometric and isotonic exercises).
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
10 cm Visual Analogue Scale (0 best, 10 worst pain)
Time Frame
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.
Title
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Description
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.
Time Frame
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.
Title
Knee isokinetic power
Description
Knee flexion and extension strengths will be evaluated with an isokinetic dynamometer.
Time Frame
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.
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Knee osteoarthritis is more common in women.
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Halil Ogut, Dr.
Organizational Affiliation
Hatay Mustafa Kemal University Faculty of Medicine
Official's Role
Study Director
Facility Information:
Facility Name
Hatay Mustafa Kemal University Faculty of Medicine
City
Hatay
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29403602
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.
Results Reference
result
PubMed Identifier
23690322
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-Oct;11(5):480.
Results Reference
result
Learn more about this trial
The Effect of Dextrose Prolotherapy on Isokinetic Power in the Treatment of Knee Osteoarthritis
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