Efficacy of Mesotherapy in Patients With Knee Osteoarthritis

NCT05190588 | Completed

• 1 other identifier: E-60116787-020-63769
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• VAS

  Visual analogue scale (Total scale score can be ranged between 0 to 10. 0: no pain, 10:worst pain)

  3 weeks

Secondary Outcomes (1)

• WOMAC scale

  3 weeks

Study Arms (2)

Exercise

NO INTERVENTION

Quadriceps Strength 10 repetition in three-set, 5 times a week

Mesotherapy

ACTIVE COMPARATOR

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.

Other: Mesotherapy

Interventions

Mesotherapy OTHER

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.

Mesotherapy

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed as Knee Osteoarthritis according to ACR criteria

You may not qualify if:

• 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

Sponsors & Collaborators

• Pamukkale University: lead

Study Sites (1)

Pamukkale University

Denizli, None Selected, 20100, Turkey (Türkiye)

Location

Related Publications (5)

• 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.

  PMID: 12965941 BACKGROUND

• 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.

  PMID: 11407681 BACKGROUND

• 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.

  PMID: 11281736 BACKGROUND

• 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.

  PMID: 28544687 BACKGROUND

• 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.

  PMID: 30876777 BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Mesotherapy

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Cosmetic Techniques; Injections, Subcutaneous; Injections; Drug Administration Routes; Drug Therapy

Study Officials

• Ayşe Sarsan

  Pamukkale U

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: prospective randomized controlled clinical study

Study Record Dates

• First Submitted: November 26, 2021
• First Posted: January 13, 2022
• Study Start: April 27, 2022
• Primary Completion: July 15, 2022
• Study Completion: December 15, 2022
• Last Updated: November 8, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)