Investigation of acupuncture effectiveness in reducing pain and improving shoulder function in patients with rotator cuff tendinopathy
Design
Clinical trials with a control group, single-blind, randomized. Patients are randomly divided into two groups using SPSS software.
Settings and conduct
This study will be performed on all patients referred to the Physical Medicine and Rehabilitation Clinics of Isfahan University of Medical Sciences in 2019, whose diagnosis of rotator cuff tendinopathy has been confirmed. Sampling will be done based on inclusion and exclusion criteria and for each treatment group, 18 samples and a total of 36 samples will be considered. The statistical analyst of this study will be blinded (single-blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria: patients with unilateral rotator cuff tendinopathy, the signature of the consent form and have previous normal radiography of the shoulder.
Exclusion criteria: previous surgery of the injured shoulder, luxation or fracture near the shoulder, direct or indirect severe injuries following traction, neurological injuries or illnesses with musculoskeletal disorders, vascular disorders in the lower extremities.
Intervention groups
Control group: In this group, the drug treatment will be one tablet of meloxicam 15 mg with food once a day for two weeks and exercise therapy three times a week for three weeks.
Intervention group: In this group, the drug treatment will be one tablet of meloxicam 15 mg with food once a day for two weeks and exercise therapy three times a week for three weeks and acupuncture treatment three sessions per week over three weeks.
Main outcome variables
Clinical parameters include: pain, shoulder joint function, and Painful range of shoulder joint before, immediately and three months after the intervention.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200514047443N1
Registration date:2020-10-08, 1399/07/17
Registration timing:registered_while_recruiting
Last update:2020-10-08, 1399/07/17
Update count:0
Registration date
2020-10-08, 1399/07/17
Registrant information
Name
Faranak Seydi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 84 3362 2690
Email address
faranakseydi1992@resident.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-05-28, 1399/03/08
Expected recruitment end date
2021-03-20, 1399/12/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of acupuncture effectiveness in reducing pain and improving shoulder function in patients with rotator cuff tendinopathy
Public title
Acupuncture effectiveness in reducing pain and improving shoulder function in patients with rotator cuff tendinopathy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with unilateral rotator cuff tendinopathy
Signature of consent form
Have previous normal radiography of the shoulder
Exclusion criteria:
previous surgery of the injured shoulder
luxation or fracture near the shoulder
Direct or indirect severe injuries following traction
Coagulation disorders
neurological injuries or illnesses with musculoskeletal disorders
Vascular disorders in the lower extremities
lymphedema
Kidney disease (creatinine greater than 1.5)
ِDrug consumption
History of cancer
Inability to communicate and cognitive impairment
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
Data analyser
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Samples are selected by available and non-probabilistic methods and from among them, patients who meet the
inclusion criteria will be selected. Then patients will be divided into two groups of control and intervention by simple random method (code will be assigned to each sample) and using SPSS statistical software. In this study, concealment will be performed by using the method of using sequentially numbered, sealed, opaque envelopes.
Blinding (investigator's opinion)
Single blinded
Blinding description
In this study, only the statistical analyst will be unaware of the groups studied.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-29, 1398/12/10
Ethics committee reference number
IR.MUI.MED.REC.1398.621
Health conditions studied
1
Description of health condition studied
Rotator cuff tendinopathy
ICD-10 code
M75.4
ICD-10 code description
Impingement syndrome of shoulder
Primary outcomes
1
Description
Pain
Timepoint
Before, immediately and three months after the intervention
Method of measurement
with Visual analogue scale (VAS)
2
Description
Shoulder joint function
Timepoint
Before, immediately and three months after the intervention
Method of measurement
Disabilities of the Arm, Shoulder, and Hand outcome Measure (DASH)
3
Description
Painful range of shoulder joint
Timepoint
Before, immediately and three months after the intervention
Method of measurement
with Goniometer
Secondary outcomes
empty
Intervention groups
1
Description
Control group: In this group, the drug treatment will be one tablet of meloxicam 15 mg with food once a day for two weeks and exercise therapy three times a week for three weeks.
Category
Treatment - Other
2
Description
Intervention group: In this group, the drug treatment will be one tablet of meloxicam 15 mg with food once a day for two weeks and exercise therapy three times a week for three weeks and acupuncture treatment three sessions per week over three weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Clinics of Isfahan University of Medical Sciences
Full name of responsible person
Faranak Seydi
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Faranakseydi71@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Parisa Taheri
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
prs_taheri@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Faranak Seydi
Position
Post Graduate
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Faranakseydi71@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faranak seydi
Position
Post Graduate
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Faranakseydi71@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Faranak seydi
Position
Post Graduate
Latest degree
Medical doctor
Other areas of specialty/work
Physical Medicine
Street address
Hezar Jerib Ave
City
Isfahan
Province
Isfehan
Postal code
8174675731
Phone
+98 31 3670 0666
Email
Faranakseydi71@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
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