Protocol summary

Study aim
Comparison of effectiveness of piroxicam ampoule mesotherapy injection and shockwave modality on clinical manifestations and performance in patients with knee arthritis
Design
The clinical trial has a control group, with parallel groups, a blind strain, randomized, phase two on 60 patients, the method of random assignment in This study is the permutation block method of 4
Settings and conduct
Project location: Imam Reza Physical Medicine and Rehabilitation Clinic the patients are divided into two groups, the first group is the mesotherapy injection of piroxicam ampoule in certain points of the knee and the second group is the shockwave modality in the painful points around the knee. Blinding is also done in a one-way blind way where the clinical supervisor does not know the type of study
Participants/Inclusion and exclusion criteria
Inclusion criteria: mild and moderate osteoarthritis of the knee exclusion criteria: history of knee injection and knee injury, any kind of surgery on the knee. Various diseases including diabetes and...
Intervention groups
The first group: patients received a subcutaneous injection containing a Combination of piroxicam and lidocaine 2%, at the acupuncture points ST34, ST35, SP9, BL 38, SP10, LR7 around the knee. After 10 days, the injection will Be done again (each patient will receive two mesotherapy sessions). The second group treated with shockwave modality, patients will receive 0.05 MJ/mm2 of total energy with 1000 pulses per week for 3 weeks.
Main outcome variables
Patient performance ,dependent ,somewhat continuous Pain level ,dependent ,somewhat discrete

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250622066221N1
Registration date: 2025-08-18, 1404/05/27
Registration timing: prospective

Last update: 2025-08-18, 1404/05/27
Update count: 0
Registration date
2025-08-18, 1404/05/27
Registrant information
Name
Ramin Ardeshiri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 933 935 3624
Email address
ramin_ardeshiri@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-02, 1404/06/11
Expected recruitment end date
2026-02-10, 1404/11/21
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A comparative study of the efficacy of piroxicam ampoule mesotherapy injection and shockwave modality on the clinical manifestations of knee osteoarthritis patients
Public title
A comparative study of the efficacy of piroxicam ampoule mesotherapy injection and shockwave modality on the clinical manifestations of knee osteoarthritis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Mild to moderate knee osteoarthritis
Exclusion criteria:
Injections in or around the knee joint in the last three months . Use of NSIAD in the last three days .History of cancer ,diabetes ,rheumatological disease and vascular collagen .Heat and redness in the knee ,History of knee injury ,History of knee Arthroplasty or other surgeries on the knee ,Presence of active Radiculopathy ,myopathy ,peripheral neuropathy ,Pregnancy or breastfeeding ,BMI>42 ,Allergy to piroxicam and other NSAID ,Severe gastrointestinal ,cardiovascular ,liver and kidney disease ,Any serious systemic or local infection such as brucellosis , Patients who have other musculoskeletal complications which Causes lower limb pain like secondary arthritis ,Patients who do Not complete the informed consent form to participate in the Study .
Age
From 35 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
  • Care provider
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be the permuted block randomization with blocks of size four. In this method, "A" represents the individual receiving the intervention, and "B" represents the individual receiving the control. Considering blocks of four, the total number of possible permutations is six, which are: ABAB, BABA, AABB, BBAA, ABBA, and BAAB. Then, using a table of random numbers and assigning codes from 0 to 9 to each permutation, a random list of 60 assignments is generated. This list includes 25 blocks of four (4 × 25 = 60, which corresponds to the total sample size). The order of assigning each method to the study participants is then determined accordingly. For example, the permutations are assigned codes as follows: ABAB = 0, BABA = 1, AABB = 2, BBAA = 3, BAAB = 4, and ABBA = 5 to 9. Then, using a table of random numbers, a random starting point is selected, and 25 numbers are randomly chosen (either row-wise or column-wise). The permutation corresponding to each selected number is recorded. (The order of the permutations will be arranged from left to right.) This process determines the allocation of all 60 participants into the two groups, A and B.
Blinding (investigator's opinion)
Single blinded
Blinding description
The study is one sided blind Clinical caregiver: to the person who is in charge of the care and follow-up of patients how to complete the questionnaires ,this person has no knowledge of the type of patients intervention .
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Emam hosaein dormitory hedaiat street
City
Shiraz
Province
Fars
Postal code
7134934748
Approval date
2025-08-17, 1404/05/26
Ethics committee reference number
IR.SUMS.MED.REC.1403.751

Health conditions studied

1

Description of health condition studied
Osteoarthritis of knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee

Primary outcomes

1

Description
Osteoarthritis of knee
Timepoint
Measurement of knee joint cartilage thickness and evaluation of knee effusion before immediately after and one month after injection of piroxicam ampoule and shockwave modality
Method of measurement
Visual analog scale , western Ontario and Mc master universities arthritis index , Oxford knee scale

Secondary outcomes

1

Description
Improve pain and function
Timepoint
Investigation of pain improvement and performance ten days and one month after piroxicam mesotherapy injection and shockwave modality
Method of measurement
Visual analog scale , Western Ontario and Mc Master universities arthritis index ,oxford knee scale

Intervention groups

1

Description
The first intervention group: Patients received subcutaneous injections containing a combination of 20 mg, 1 ml of piroxicam and 5 cc of lidocaine 2%, in acupuncture points ST34, ST35, SP9, BL 38, SP10, LR7 around the knee ,The angle of the needle when entering the skin should be 30-45 degrees, after 10 days, the injection will be done again (each Patient will receive two mesotherapy sessions).The second intervention group: Under treatment with shock wave modality, patients will receive 0.05 millijoules per square millimeter of total energy with 1000 pulses per week for 3 weeks.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam reza clinic
Full name of responsible person
Sharareh roshanzamir
Street address
Emam raza clinic namazi square
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Hamid mohamadi
Street address
Emam hosaien dormitory hedaiat street
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7001
Email
emamreza@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ramin Ardeshiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam hosaein dormitory ,hadaiat street
City
Shiraz
Province
Fars
Postal code
7134934748
Phone
+98 83 3835 3624
Email
ramin.ardeshiri@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Sharareh roshanzamir
Position
Associate professo
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Emam hosaein dormitory , hedaiat street
City
Shiraz
Province
Fars
Postal code
7134934748
Phone
+98 83 3835 3624
Email
Sharareh.roshanzamir@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Ramin ardeshiri
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Emam hosaein dormitory ,hedaiat street
City
Shiraz
Province
Fars
Postal code
7134934748
Phone
+98 83 3835 3624
Email
ramin.ardeshiri@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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