Efficacy of Mesotherapy in Patients With Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Mesotherapy
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Diagnosed as Knee Osteoarthritis according to ACR criteria
Exclusion Criteria:
- Smaller than 40 years old
- Those who give false and contradictory information,
- Those who are poorly oriented with cooperation, -Patients using non-steroidal anti-inflammatory, patients with a history of knee surgery, --
- Patients with meniscus lesions
Sites / Locations
- Pamukkale UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
Exercise
Mesotherapy
Arm Description
Quadriceps Strength 10 repetition in three-set, 5 times a week
Group 2: Mesotherapy (MT) Sterile and disposable (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used. Patients will receive 2 ml of 2% lidocaine, 2 ml of pentoxifylline and will be used. Injection techniques (IDP=2-4 MM) AND (IDS=1-2 MM) will be used. One time a week for a total of 3 times.
Outcomes
Primary Outcome Measures
VAS
Visual analogue scale (Total scale score can be ranged between 0 to 10. 0: no pain, 10:worst pain)
Secondary Outcome Measures
WOMAC scale
Western Ontario and McMaster Universities Osteoarthritis Index (Test Questions are scored on a scale of 0-4 which correpond to: none(0), mild(1), moderate (2), severe (3) extreme (4). The scores for each subscales are summed up with a possible score 0-20 for pain, 0-8 for stiffness, 0-68 for physical function.)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05190588
Brief Title
Efficacy of Mesotherapy in Patients With Knee Osteoarthritis
Official Title
Efficacy of Mesotherapy on Pain and Function in Patients With Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 27, 2022 (Actual)
Primary Completion Date
July 15, 2022 (Anticipated)
Study Completion Date
August 15, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Purpose: The investigators aimed to determine whether this treatment is effective on pain and function by applying mesotherapy treatment to patients followed up with gonarthrosis.
Methods: This study is a prospective randomized controlled study. The research will be carried out between November 2021 and April 2022 in Pamukkale University Physical Medicine and Rehabilitation (PMR) After the approval of the Pamukkale University Faculty of Medicine Ethics Committee, 38 patients diagnosed with gonarthrosis will be divided into 2 groups using a table of random numbers. The first group will be the group that only applied quadriceps strength exercise and Mesotherapy will be applied to the second group along with quadriceps strength exercise.
The data will be analyzed with the SPSS package program. Continuous variables will be given as mean ± standard deviation and categorical variables as numbers and percentages. parametric test Test of Significance of Difference Between Two Means in comparison of independent group differences when assumptions are met; When parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent group differences. In addition, the relationships between continuous variables will be examined with Spearman or Pearson correlation analyzes and the differences between categorical variables will be examined with Chi-square analysis. Since there is no similar study conducted and there is no possibility to conduct a pilot study, assuming that a moderate effect size will be obtained as a result of the power analysis made in the direction of the hypothetical expectations, it was taken to obtain 80% power with 95% confidence, and it was calculated that at least 38 people should be included in the study.
Detailed Description
Detailed Description:
This study is a prospective randomized controlled study. The research will be carried out in Pamukkale University Physical Medicine and Rehabilitation (PMR) After the approval of the Pamukkale University Faculty of Medicine Ethics Committee,38 participants will be admitted to Pamukkale University PMR clinic will be included in this study. Patients will be informed about the content, purpose, and application of the study and their written consent will be obtained.
Treatment Protocol 38 patients diagnosed with gonarthrosis will be divided into 2 groups using random numbers table. The first group will be the group that only applied quadriceps strength exercise and Mesotherapy will be applied to the second group along with quadriceps strength exercise.
Group 1: Exercise Group (Quadriceps Strength)10 repetition in three-set, 5 times a week for three weeks Group 2: Mesotherapy (MT) once a week for three weeks. Patients will receive 2 ml of 2% lidocaine, 2 ml of pentoxifylline will be used. Sterile and disposable (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used for mesotherapy. and injection techniques (IDP=2-4 MM) AND (IDS=1-2 MM) will be used.
Statistics The data will be analyzed with the SPSS package program. Continuous variables will be given as mean ± standard deviation and categorical variables as numbers and percentages. parametric test
Test of Significance of Difference Between Two Means in comparison of independent group differences when assumptions are met; When parametric test assumptions are not met, the Mann-Whitney U test will be used to compare independent group differences. In addition, the relationships between continuous variables will be examined with Spearman or Pearson correlation analyzes and the differences between categorical variables will be examined with Chi-square analysis. Since there is no similar study conducted and there is no possibility to conduct a pilot study, assuming that a moderate effect size will be obtained as a result of the power analysis made in the direction of the hypothetical expectations, it was taken to obtain 80% power with 95% confidence, and it was calculated that at least 38 people should be included in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomized controlled clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
No Intervention
Arm Description
Quadriceps Strength 10 repetition in three-set, 5 times a week
Arm Title
Mesotherapy
Arm Type
Active Comparator
Arm Description
Group 2: Mesotherapy (MT) Sterile and disposable (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used. Patients will receive 2 ml of 2% lidocaine, 2 ml of pentoxifylline and will be used. Injection techniques (IDP=2-4 MM) AND (IDS=1-2 MM) will be used. One time a week for a total of 3 times.
Intervention Type
Other
Intervention Name(s)
Mesotherapy
Intervention Description
Mesotherapy (MT) Sterile and disposable (0.26mm × 4mm and 0.3mm × 13 mm, Terumo) will be used. Patients will receive 2 ml of 2% lidocaine, 2 ml of pentoxifylline and will be used. Injection techniques (IDP=2-4 MM) AND (IDS=1-2 MM) will be used.
Primary Outcome Measure Information:
Title
VAS
Description
Visual analogue scale (Total scale score can be ranged between 0 to 10. 0: no pain, 10:worst pain)
Time Frame
3 weeks
Secondary Outcome Measure Information:
Title
WOMAC scale
Description
Western Ontario and McMaster Universities Osteoarthritis Index (Test Questions are scored on a scale of 0-4 which correpond to: none(0), mild(1), moderate (2), severe (3) extreme (4). The scores for each subscales are summed up with a possible score 0-20 for pain, 0-8 for stiffness, 0-68 for physical function.)
Time Frame
3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosed as Knee Osteoarthritis according to ACR criteria
Exclusion Criteria:
Smaller than 40 years old
Those who give false and contradictory information,
Those who are poorly oriented with cooperation, -Patients using non-steroidal anti-inflammatory, patients with a history of knee surgery, --
Patients with meniscus lesions
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ayşe Sarsan, M.D
Phone
+902582966000
Email
aysa90@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayşe Sarsan
Organizational Affiliation
Pamukkale U
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
None Selected
ZIP/Postal Code
20100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayşe Sarsan
Phone
+902582966000
Email
aysa90@yahoo.com
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
12965941
Citation
Felson DT, McLaughlin S, Goggins J, LaValley MP, Gale ME, Totterman S, Li W, Hill C, Gale D. Bone marrow edema and its relation to progression of knee osteoarthritis. Ann Intern Med. 2003 Sep 2;139(5 Pt 1):330-6. doi: 10.7326/0003-4819-139-5_part_1-200309020-00008.
Results Reference
background
PubMed Identifier
11407681
Citation
Pelletier JP, Martel-Pelletier J, Abramson SB. Osteoarthritis, an inflammatory disease: potential implication for the selection of new therapeutic targets. Arthritis Rheum. 2001 Jun;44(6):1237-47. doi: 10.1002/1529-0131(200106)44:63.0.CO;2-F. No abstract available.
Results Reference
background
PubMed Identifier
11281736
Citation
Felson DT, Chaisson CE, Hill CL, Totterman SM, Gale ME, Skinner KM, Kazis L, Gale DR. The association of bone marrow lesions with pain in knee osteoarthritis. Ann Intern Med. 2001 Apr 3;134(7):541-9. doi: 10.7326/0003-4819-134-7-200104030-00007.
Results Reference
background
PubMed Identifier
28544687
Citation
Huang L, Guo B, Xu F, Zhao J. Effects of quadriceps functional exercise with isometric contraction in the treatment of knee osteoarthritis. Int J Rheum Dis. 2018 May;21(5):952-959. doi: 10.1111/1756-185X.13082. Epub 2017 May 25.
Results Reference
background
PubMed Identifier
30876777
Citation
Kocak AO. Intradermal mesotherapy versus systemic therapy in the treatment of musculoskeletal pain: A prospective randomized study. Am J Emerg Med. 2019 Nov;37(11):2061-2065. doi: 10.1016/j.ajem.2019.02.042. Epub 2019 Feb 28.
Results Reference
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Efficacy of Mesotherapy in Patients With Knee Osteoarthritis
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