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Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group (oral medication and splinting alone)

Protocol summary

Study aim
Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group
Design
The clinical trial has a control group, with parallel groups, randomized, phase 2 on 54 patients, the random allocation method in this study will be the permutation block method of 6.
Settings and conduct
Patients referred to the physical medicine and rehabilitation clinics of Shiraz University of Medical Sciences are divided into three groups. The first group is administered oral naproxen 500 mg tablets twice a day (once every twelve hours) for 7 days. The second group Mesotherapy with piroxicam is used in the desired acupuncture points and the maximum tenderness point with a combination of 1 cc of 20 mg piroxicam and 4 cc of 2% lidocaine on two occasions of 0 and 7 days.The third group of acupuncture is inserted in the desired acupuncture points and points with maximum tenderness. Acupuncture sessions are performed for 4 weeks and between 2 to 3 times per week. Patients benefit from joint treatment of stretching exercises and strengthening wrist extensors.
Participants/Inclusion and exclusion criteria
Patients who have been at least 3 months since the onset of symptoms and have not responded to initial and conservative treatments are included in the study, and patients with any elbow injection, elbow and upper limb physiotherapy during the past 3 months are excluded from the study.
Intervention groups
Group A: oral naproxen and stretching and strengthening exercises for wrist extensor muscles + cock up splint Group B: Piroxacam and lidocaine mesotherapy + stretching exercises and strengthening the wrist extensor muscles Group C: Acupuncture and stretching exercises and strengthening the wrist extensor muscles
Main outcome variables
Amount and severity of pain and functional limitations of patients with tennis elbow

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20250122064481N1
Registration date: 2025-01-24, 1403/11/05
Registration timing: prospective

Last update: 2025-01-24, 1403/11/05
Update count: 0
Registration date
2025-01-24, 1403/11/05
Registrant information
Name
Mahshid Malekmohamadi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 34 3261 1443
Email address
malekmohammadi@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-19, 1403/12/01
Expected recruitment end date
2025-09-22, 1404/06/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group (oral medication and splinting alone)
Public title
Investigating the effect of acupuncture versus mesotherapy in the treatment of tennis elbow compared to the control group (oral medication and splinting alone)
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Completing and signing the consent form Clinical diagnosis of tennis elbow in the form of pain in the external epicondyle region of the humerus bone by local pressure and wrist extension against resistance Age between 25 and 70 years At least 3 months have passed since the onset of symptoms They have not responded to primary and conservative treatments
Exclusion criteria:
Any clinical symptoms of effusion, inflammation, redness and warmth of the involved area Having uncontrolled diabetes, rheumatic diseases and vascular collagen, myopathy, any serious systemic and local infection, Brucella, bleeding diseases History of surgery in the elbow joint of the affected side Severe deformity of the upper limbs Inability to communicate and complete questionnaires History of allergies and allergic reactions to the drugs used, history of significant liver, kidney, brain and cardiopulmonary disorders, history of injections in or around the affected joint in the last 3 months, history of elbow and upper limb physiotherapy in the last 1 month Stable use of NASID in the last 48 hours Pregnant and lactating women, people with cancer People who are using anticoagulants
Age
From 25 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 54
More than 1 sample in each individual
Number of samples in each individual: 18
The study of a clinical trial on 54 patients in three treatment groups, each treatment group includes 18 patients, and the therapeutic interventions of the groups are compared.
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization: The random allocation method in this study will be the permutation block method of 6 such that A represents the person who receives intervention 1, B represents the person who receives intervention 2, and C represents the person who is placed in the control group. How to hide the allocation of participants: 1. A______________________________________ 2. C______________________________________ 3. C______________________________________ 4. C______________________________________ 5. A______________________________________ 6. B______________________________________ 7. B______________________________________ 8. B______________________________________ 9. C______________________________________ 10. A______________________________________ 11. B______________________________________ 12. C______________________________________ 13. C______________________________________ 14. B______________________________________ 15. A______________________________________ 16. A______________________________________ 17. A______________________________________ 18. B______________________________________ 19. B______________________________________ 20. B______________________________________ 21. C______________________________________ 22. A______________________________________ 23. B______________________________________ 24. A______________________________________ 25. B______________________________________ 26. C______________________________________ 27. A______________________________________ 28. C______________________________________ 29. A______________________________________ 30. A______________________________________ 31. B______________________________________ 32. C______________________________________ 33. A______________________________________ 36. C______________________________________ 35. C______________________________________ 36. B______________________________________ 37. B______________________________________ 38. B______________________________________ 39. C______________________________________ 40. A______________________________________ 41. C______________________________________ 42. B______________________________________ 43. B______________________________________ 44. A______________________________________ 45. C______________________________________ 46. A______________________________________ 47. A______________________________________ 48. C______________________________________ 49. B______________________________________ 50. A______________________________________ 51. A______________________________________ 52. C______________________________________ 53. B______________________________________ 54. C______________________________________ In order to hide the random sequence method, another person who is unaware of the research process is provided, and the questionnaires are completed by a person who is unaware of the division of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
The differences of opinion among the treatment methods for tennis elbow and the lack of a study comparing the effect of mesotherapy and acupuncture against the control group in the treatment of these patients, due to the safety and low cost of these two treatment methods and the absence of side effects Other treatment methods such as side effects caused by corticosteroid injection, this study was conducted with the aim of comparing these treatment methods.

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
No.6 Eram dormitory, Eram square
City
Shiraz
Province
Fars
Postal code
7194685791
Approval date
2025-01-20, 1403/11/01
Ethics committee reference number
IR.SUMS.MED.REC.1403.680

Health conditions studied

1

Description of health condition studied
Tennis elbow
ICD-10 code
M77.1
ICD-10 code description
Lateral epicondylitis

Primary outcomes

1

Description
intensity of pain
Timepoint
Before starting the treatment and 2 and 4 weeks after the treatment
Method of measurement
Visual Analog Scale

2

Description
performance
Timepoint
Before starting the treatment and 2 and 4 weeks after the treatment
Method of measurement
Patient-Rated Tennis Elbow Evaluation

Secondary outcomes

empty

Intervention groups

1

Description
The first intervention group: to perform mesotherapy with piroxicam, we insert the needle into the skin at an angle of 10 degrees and horizontally. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and the maximum tenderness point, which is composed of one cc of piroxicam 20 mg. And 4 cc of 2% lidocaine is used in each point with a depth of one to three millimeters and on two occasions of 0 and 7 days. Injections are performed using 5 cc disposable sterile syringes with a thin needle head (0.27 mm x 4 mm).Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance.
Category
Treatment - Drugs

2

Description
The second intervention group: A special acupuncture needle with a size of 13 x 18 cm is used to perform acupuncture. The needle entry point is the acupuncture points Lu5, Li10, Li11, Li12 and points with maximum tenderness. The depth of needle insertion is selected according to the recommendations of traditional Chinese acupuncture for classic points and the needles are removed after 25 minutes. Acupuncture sessions are performed for 4 weeks and between 2 to 3 sessions per week (on average, each patient has at least 10 sessions during He is treated with acupuncture for 4 weeks.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance.
Category
Treatment - Devices

3

Description
Control group: Oral naproxen tablets of 500 mg are used twice a day (once every twelve hours) for a period of 7 days.Stretching exercises (for two weeks) and strengthening of wrist extensors (after two weeks) are used. The duration of each exercise is 15 to 30 seconds and is repeated 10 to 30 times a day according to the patient's tolerance.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Rajaei hospital
Full name of responsible person
Hossein Alikhalili
Street address
Shahid Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
sharareh.roshanzamir@gmail.com
Web page address
https://rajaeehosp.sums.ac.ir

2

Recruitment center
Name of recruitment center
Imam Reza (a.s.) special specialized and super-specialized clinic
Full name of responsible person
Ali jangjou
Street address
Namazi Square, next to Namazi Hospital
City
Shiraz
Province
Fars
Postal code
7134814734
Phone
+98 71 3212 7000
Fax
Email
sharareh.roshanzamir@gmail.com
Web page address
https://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
Shiraz, Zand Street, in front of Palestine Street, central building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
mohammadi@sums.ac.ir
Web page address
https://research.sums.ac.ir/assistant
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
Mahshid Malekmohamadi
Position
Physical medicine and rehabilitation Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.6 Eram dormitory.,Eram square.,Shiraz
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 34 3261 1443
Fax
Email
malekmohammadi@sums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahshid Malekmohamadi
Position
Physical medicine and rehabilitation Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.6 Eram dormitory.,Eram square.,Shiraz
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 34 3261 1443
Fax
Email
malekmohammadi@sums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mahshid Malekmohamadi
Position
Physical medicine and rehabilitation Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.6 Eram dormitory.,Eram square.,Shiraz
City
Shiraz
Province
Fars
Postal code
7194685791
Phone
+98 34 3261 1443
Fax
Email
malekmohammadi@sums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is 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
Title and more details about the data/document
The results of completing the questionnaires on improving pain and function are published without mentioning the names and personal information of the patients.
When the data will become available and for how long
The access period starts after the results are printed
To whom data/document is available
Only for researchers working in academic and scientific institutions
Under which criteria data/document could be used
Only data analysis in terms of quality of life improvement in tennis elbow patients is allowed.
From where data/document is obtainable
malekmohammadi@sums.ac.ir
What processes are involved for a request to access data/document
3 to 6 months after receiving the applicant's email
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