The Comparison of the Effectiveness of Piroxicam Mesotherapy versus Ultrasound-Guided Corticosteroid Injection in Reducing Pain and Improving Function in Patients with Non Specific Shoulder Pain
Comparison of piroxicam mesotherapy with ultrasound-guided corticosteroid injection in reducing pain and improving function in patients with non specific shoulder pain
Design
The research is a randomized double blind clinical trial on 58 patients
Settings and conduct
Samples are selected from patients with non specific shoulder pain referred to Imam Reza Clinic and Rajaee Hospital divided into two groups The blocked randomized method is used. After obtaining informed consent, In control group corticosteroid is injected under guide of ultrasound and in intervention group piroxicam mesotherapy is done Finally effects on pain reduction and functional improvement are measured
Participants/Inclusion and exclusion criteria
Inclusion criteria:Age over 18 y/o Shoulder pain lasted more than 4 weeks with VAS score of at least 4 in a recent month Absence of any disease around the shoulder joint
Exclusion criteria:Any pathology on radiograph Degenerative shoulder joint Clinical signs of inflammation in affected shoulder Diabetes Mellitus Uncontrolled hypertension Rheumatic and collagen vascular diseases Lupus Gout Radiculopathy Myopathy Nerve injuries Neuropathy Stroke Infection Brucellosis BMI above 42 Shoulder joint replacement on the affected side Hx of shoulder trauma,fracture Severe deformities of the upper limbs Bleeding disorders Use of anticoagulants Mental Psychological problems Hx of allergies to the used drugs Hx of significant liver, kidney, brain, cardiopulmonary disorders Hx of intraarticular or periarticular injections at the affected joint in the last 3 months Hx of shoulder and upper limb physiotherapy in the last 1 month Pregnancy Lactating Malignancy
Intervention groups
Group A undergoes piroxicam mesotherapy in the affected shoulder Group B undergoes local corticosteroid injection using ultrasound guide in the affected shoulder
Main outcome variables
Pain, Activity of daily living
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210423051050N1
Registration date:2021-05-11, 1400/02/21
Registration timing:prospective
Last update:2021-05-11, 1400/02/21
Update count:0
Registration date
2021-05-11, 1400/02/21
Registrant information
Name
Mohammad Hossein Jabbedari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3633 2701
Email address
h_jabbedari@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-21, 1400/03/31
Expected recruitment end date
2022-01-20, 1400/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of the Effectiveness of Piroxicam Mesotherapy versus Ultrasound-Guided Corticosteroid Injection in Reducing Pain and Improving Function in Patients with Non Specific Shoulder Pain
Public title
Evaluation of the Effect of Subcutaneous Injection of Piroxicam in Patients with Non Specific Shoulder Pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients over 18 years of age
Male or Female gender
Completing and signing the informed consent form
Patients with shoulder pain lasted more than 4 weeks and with a shoulder pain Visual Analog Scale (VAS) score of at least 4 in a recent month
Absence of any disease around the affected shoulder joint
Exclusion criteria:
Any pathology found on plain radiograph such as degenerative findings of the shoulder joint
Any clinical signs of effusion, inflammation, redness and warmth of the affected shoulder
Diabetes Mellitus
Uncontrolled Hypertension
Rheumatic and Collagen Vascular Diseases such as Lupus and Gout
Concomitant Radiculopathy (cervical radiculopathy), Myopathy, Nerve injuries and Neuropathies (including CTS)
Stroke
Any serious systemic and local infection
Brucellosis
BMI above 42
History of shoulder joint replacement on the affected side
History of shoulder trauma and fracture and severe deformities of the upper limbs
Bleeding tendency and bleeding disorders and/or use of anticoagulants
Inability to communicate and complete questionnaires (Mental and Psychological problems)
History of allergies and allergic reactions to the used drugs including piroxicam, corticosteroids and lidocaine
History of significant liver, kidney, brain and cardiopulmonary disorders
History of intraarticular or periarticular injections at the affected shoulder joint in the last 3 months
History of shoulder and upper limb physiotherapy (physical therapy) in the last 1 month
Pregnant and Lactating women
Patients with Cancer or Malignancy
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
To match patients in the intervention and control groups, patients are randomly assigned to one of two treatment groups. The random allocation method in this study will be the permutation blocks randomization method with 4 samples in each block and a random list of data will be obtained by using Random Allocation software. We will have two lists of 29 patients, including the two intervention and control groups, at random. For concealment, method of random sequencing is given to another person who is unaware of the research process, and the questionnaires are completed by a person unaware of the division of groups.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant: in this study, we does not have the ability to blind the participant because the participant is aware of receiving each intervention. Clinical care giver: we teach the caregiver how to complete the questionnaire. This person is not aware of receiving patient’s intervention. Researcher: this study does not have the ability to blind the researcher due to performing both interventions by himself and being aware of receiving the kind of intervention in each group. The outcome assessor of the complete questionnaires is given to a person who is not aware of the intervention performed and he/she is asked to determine the level of performance in each person according to the questionnaires. Data analyzer: questionnaire are finally given to a person to review the information. This person does not know any of the steps of the work and the way of classification in which the intervention performed.
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
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
City
Shiraz
Province
Fars
Postal code
7185988717
Approval date
2021-04-21, 1400/02/01
Ethics committee reference number
IR.SUMS.MED.REC.1400.051
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; two weeks, four weeks, eight weeks and twelve weeks later
Method of measurement
Visual Analogue Scale; Oxford Shoulder Score
Secondary outcomes
1
Description
Function of patient
Timepoint
Before intervention; two weeks, four weeks, eight weeks and twelve weeks later
Method of measurement
Oxford Shoulder Score
Intervention groups
1
Description
Intervention group: Subcutaneous injection (mesotherapy) of 1 ml piroxicam 20 mg/ml with 4 ml lidocaine 2% is applied in tender points of the affected shoulder and around the affected shoulder as a grid pattern where each point was at least 1 cm away from the others. Mesotherapy is performed in 3 sessions at intervals of one week according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and 12 weeks after intervention.
Category
Rehabilitation
2
Description
Control group: Injection of 1 ml corticosteroid methylprednisolone acetate 40 mg/ml with 4 ml lidocaine 2% is applied locally at the site of the lesion and in the affected shoulder under guide of ultrasonography. Corticosteroid injection is performed in one session according to the common and sterile protocol along with lifestyle modification and doing appropriate exercises for shoulder pain. The patients have to complete the Visual Analog Scale and Oxford Shoulder Score questionnaires before entering the study and 2,4,8 and12 weeks after intervention.
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
714737-71348
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
Chamran Blvd, near to Niayesh Boulevard
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 Avenue
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
Mohammad Hossein Jabbedari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
City
Shiraz
Province
Fars
Postal code
7185988717
Phone
+98 71 3633 2701
Email
ja.mohammadh@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Jabbedari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
City
Shiraz
Province
Fars
Postal code
7185988717
Phone
+98 71 3633 2701
Email
ja.mohammadh@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Mohammad Hossein Jabbedari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
6th Alley, Takestan Ave., Shahid Rajaei Blvd.
City
Shiraz
Province
Fars
Postal code
7185988717
Phone
+98 71 3633 2701
Email
ja.mohammadh@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 available 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. Mohammad Hossein Jabbedari, 00989389443577 , ja.mohammadh@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.