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Comparison of the Effectiveness of Methyl Prednisolone Acetate Injection at the Jianqian Acupoint versus Oral Piroxicam in Reducing Pain and Improving Function in patients with Non Specific Shoulder Pain

Protocol summary

Study aim
Comparison of the effect of Methyl Prednisolone Acetate injection at the Jianqian acupoint versus oral Piroxicam in reducing pain and improving function in patients with non specific shoulder pain
Design
Study of a clinical trial with a control group, with parallel groups, double-blinded, randomized on 58 patients. There is no trial phase. Permutation block is used for randomization.
Settings and conduct
The samples are selected from patients with non-specific shoulder pain referred to Imam Reza Clinic and Rajaei Hospital and divided into two groups. Blocked random method is used and the study begins after obtaining informed consent. We give oral Piroxicam for control group and inject Methyl Prednisolone acetate at the Jianqian acupoint for the intervention group . Finally effect on pain reduction, functional improvement and range of motion of shoulder are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Non-specific shoulder pain lasted more than 6 weeks with active movement restriction in at least one plane Exclusion criteria: Any infection and inflammation, Acute trauma, Fractures, Dislocations, History of allergy to drugs, Any contraindications for the used drugs, Pregnant, Lactating, Malignancy, History of injection or physical therapy in the past month, Active rheumatism, Uncontrolled hypertension, Diabetes Mellitus
Intervention groups
Intervention Group: A mixture of 40 mg Methyl Prednisolone Acetat and 4 cc Lidocaine 2% is injected at Jianqian acupoint. Control Group: This group takes 10mg Piroxicam capsules twice daily for 2 weeks.
Main outcome variables
Pain; Range of motion of shoulder; Function of patient

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20220718055488N1
Registration date: 2022-07-28, 1401/05/06
Registration timing: prospective

Last update: 2022-07-28, 1401/05/06
Update count: 0
Registration date
2022-07-28, 1401/05/06
Registrant information
Name
Lale Zare
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3621 2959
Email address
dr.lalezare@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-08-06, 1401/05/15
Expected recruitment end date
2023-02-20, 1401/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the Effectiveness of Methyl Prednisolone Acetate Injection at the Jianqian Acupoint versus Oral Piroxicam in Reducing Pain and Improving Function in patients with Non Specific Shoulder Pain
Public title
Effect of Methyl Prednisolone Acetate injection at the Jianqian Acupoint in Patients with Non Specific Shoulder Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years old Non-specific shoulder pain lasted more than 6 weeks Limitation of active range of motion in at least one plane Absence of any disease around the affected shoulder Completing and signing the informed consent
Exclusion criteria:
Any systemic or local infection Acute trauma Fracture or Dislocation Malignancy Liver or Renal failure Gastrointestinal disease, Cardiovascular disease, Asthma, DM, uncontrolled HTN History of injection or physical therapy during the last month Clinical symptoms of inflammation or infection Severe deformity of shoulder Any bleeding tendency disorders or use of anti coagulants Active rheumatologic disease Post stroke shoulder pain History of allergic reactions to the used drugs Pregnant or Lactating women Inability to communicate and completing questionnaires
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
  • Care provider
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 58
Randomization (investigator's opinion)
Randomized
Randomization description
The random allocation method in this study will be permutation block method in such a way that A represents the person for whom injection is done and B represents the person who receives oral Piroxicam. This method is based on blocks of six so that the total number of possible permutations of six is ​​equal to 6 (including: ABAB, BABA, AABB, BBAA, ABBA and BAAB). Then, by using the table of random numbers and assigning a code from 0 to 9 to each of the permutations, the desired random list of 60 items, which includes 15 blocks of 4 items (total number of samples = 60 x 15) is generated and the order of assigning each One of the methods is specified for each of the samples participating in the study.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: In this study, we do not have the ability to blind the patient because the patients are aware of the type of intervention. Clinical caregiver: We train the person who is in charge of the care and follow-up of patients how to complete the questionnaire. This person has no awareness of the patient's intervention. Researcher: In this study, we do not have the ability to blind the researcher because the intervention is carried out by him. Outcome assessor: Completed questionnaires are given to a person who does not know about the interventions and he is asked to determine the amount of pain reduction and performance improvement in each person according to the questionnaire. Data Analyzer:Finally, after completing and collecting all the information, the questionnaires are given to a person to check the information, who does not know about any of the work steps and how the intervention is divided.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee ofShiraz University of Medical Sciences
Street address
Shiraz university of medical science, Zand Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2022-05-23, 1401/03/02
Ethics committee reference number
IR.SUMS.MED.REC.1401.094

Health conditions studied

1

Description of health condition studied
Non Specific Shoulder Pain
ICD-10 code
M25.519
ICD-10 code description
Pain in unspecified shoulder

Primary outcomes

1

Description
Shoulder pain
Timepoint
Before intervention and two, four and eight weeks after intervention
Method of measurement
Visual Analog Scale and Oxford Shoulder Score questionnaires

2

Description
Range of motion of shoulder
Timepoint
Before intervention and two, four and eight weeks after intervention
Method of measurement
By goniometer, which is a device for measuring angles, the one that is used in this study is a plastic type with 360 degree rotation and an arm length of 30 cm.

Secondary outcomes

1

Description
Function of patient
Timepoint
Before intervention and two, four and eight weeks after intervention
Method of measurement
Shoulder Pain And Disability Index and Oxford Shoulder Scale questionnaires

Intervention groups

1

Description
Intervention group: At the Jianqian acupoint, which is between the axillary fold and the LI-15 acupoint (under the acromion), we inject a mixture of 40 mg of Methyl Prednisolone Acetate and 4 ml of Lidocaine2% in 5 directions in such a way that First, we insert the needle perpendicularly about 1.5 to 2 cm on the joint surface and outside the capsule and inject 1 cc of the substance, then without removing the needle, by changing the direction angle to 40 degrees to the vertical line , at upward ,downward and outside , we inject one cc on each side. At the inside, we enter at an angle of 10 degrees to the perpendicular line close to the joint capsule, and we are careful not to enter the pleura, and the injection is done. During the injection, we pay attention to the patient's reactions so as not to enter the blood vessels and nerves.
Category
Rehabilitation

2

Description
Control group: They take 10 mg Piroxicam capsules twice daily after meal and with enough water.
Category
Rehabilitation

Recruitment centers

1

Recruitment center
Name of recruitment center
Imam Reza rehabilitation clinic
Full name of responsible person
Mani Ramzi
Street address
Namazi Square
City
Shiraz
Province
Fars
Postal code
71473771348
Phone
+98 71 3212 7700
Email
motahari@sums.ac.ir

2

Recruitment center
Name of recruitment center
Rajaee hospital
Full name of responsible person
Amirreza Mesbahi
Street address
Next to Niayesh Blvd, Chamran Blvd
City
Shiraz
Province
Fars
Postal code
7194815711
Phone
+98 71 3636 4001
Email
rajaeehospital@sums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Front of Maaref school, Khalili Ave
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3628 1506
Email
info@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
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
Lale Zare
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No.3, 2nd Alley, Rayehe Ave, Golestan Town
City
Shiraz
Province
Fars
Postal code
7189895361
Phone
+98 71 3621 2959
Email
dr.lalezare@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Lale Zare
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 3, 2nd Alley, Rayehe Ave, Golestan Town
City
Shiraz
Province
Fars
Postal code
7189895361
Phone
+98 71 3621 2959
Fax
Email
dr.lalezare@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Lale Zare
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
No. 3, 2nd Alley, Rayehe Ave, Golestan Town
City
Shiraz
Province
Fars
Postal code
7189895361
Phone
+98 71 3621 2959
Fax
Email
dr.lalezare@gmail.com

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
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data can be shared after making people unidentifiable.
When the data will become available and for how long
Start access period one year after publishing the results.
To whom data/document is available
Everyone can access to this information.
Under which criteria data/document could be used
If the information in this study helps to improve the science process.
From where data/document is obtainable
dr.lale zare dr.lalezare@gmail.com
What processes are involved for a request to access data/document
After sending the desired message, all authors of the study will be consulted, all information will be sent within a maximum of three weeks if permitted.
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