Effectiveness of acupuncture on pain and function of the patients who have shoulder pain
Design
A double blinded Randomized Control Trial (RCT)
Settings and conduct
Patients with shoulder pain more than 6 weeks are referred to the sports medicine clinic of Rasoul-e-Akram Hospital, they are examined by the sports medical specialist and if tendinopathy or incomplete tear of their Rotator Cuff would be diagnosed by physical exams & confirmed by MRI findings,The therapist who performs the assessments as well as the analyzer will not know the treatment information. Outcomes are compared before and after treatment.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Shoulder pain more than six weeks Tendinopathy or partial tear of rotator cuff tendons Exclusion criteria Total tear of rotator cuff The history of shoulder surgery
Intervention groups
Intervention group 1: Acupuncture; Intervention group 2: Sham acupuncture group; Control group 3: Exercise therapy
Main outcome variables
Patients' pain and function
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20100718004409N13
Registration date:2020-04-24, 1399/02/05
Registration timing:registered_while_recruiting
Last update:2020-04-24, 1399/02/05
Update count:0
Registration date
2020-04-24, 1399/02/05
Registrant information
Name
Parisa Nejati
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4480 0361
Email address
parisanejati@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-04-19, 1399/01/31
Expected recruitment end date
2020-10-22, 1399/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of acupuncture on pain and function of the patients who have shoulder pain
Public title
The effectiveness of acupuncture on the patients who have shoulder pain
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Shoulder pain lasted more than 6 weeks
At least 3 positive specific shoulder tests
MRI findings implying tendinopathy or partial tear of rotator cuff
Exclusion criteria:
The presence of sensory or motor disturbances in the upper extremity
Evidence from other pathologies that can lead to shoulder pain. For example, the presence of calcified tendonitis or adhesive capsulitis and ...
History of shoulder surgery in the last 6 months
The presence of inflammatory rhomatologic diseases such as rheumatoid arthritis, fibromyalgia, poly mialia rheumatica and ...
Complete rupture of rotator cuff tendons based on MRI findings
History of corticosteroid, analgesic or hyaluronic acid injection in the shoulder joint over the past 3 months
History of exercise therapy and physiotherapy modalities over the past 6 weeks
Use of other therapies during the intervention period
Patients request for discontinuing the treatment
Contraindications for performing MRI
Age
From 40 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The included patients will be randomized in a simple randomization method. The random number tables found in the most statistical text books will be used for the random numbers. The numbers between 0-23 are considered for the first group, 24-47 for the second group and 48 -73for the third group. The 3 groups are 1- Acupuncture, 2- Sham & 3- Exercise therapy. concealment is performed in sequentially numbered, sealed & opaque envelopes, and will be kept by the department secretory.
Blinding (investigator's opinion)
Double blinded
Blinding description
After randomization the patients of the each group will be introduced to the researcher 2 by the researcher 1 for evaluation of the outcomes. The researcher 2 only evaluates the outcomes and records the findings without
being informed of the intervention and its effects. The analyzer receives the data at the end of the study and is not informed of the intervention groups at all.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic committee of Iran university of medical sciences
Street address
Iran University of Medical Sciences, Near the Milad Tower,Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2020-01-21, 1398/11/01
Ethics committee reference number
IR.IUMS.FMD.REC.1399.013
Health conditions studied
1
Description of health condition studied
rotator cuff tendinopathy, partial tear of rotator cuff
ICD-10 code
M75.1
ICD-10 code description
Rotator cuff tear or rupture, not specified as traumatic
2
Description of health condition studied
Shoulder impingement
ICD-10 code
M75.40
ICD-10 code description
Impingement syndrome of unspecified shoulder
Primary outcomes
1
Description
pain amount
Timepoint
Before intervention, 1 ,3 ,6 months after intervention
Method of measurement
Visual Analog Scale
2
Description
Function of the patients
Timepoint
Before intervention, 1 ,3 ,6 months after itervention
Method of measurement
Western Ontario Rotator cuff Index(WORC)questionnaires ,The Disabilities of the Arm, Shoulder, and Hand Outcome Measure (DASH) questionnaires
Secondary outcomes
1
Description
Shoulder range of motion
Timepoint
Before the intervention, 1,3,6 months after intervention
Method of measurement
Goniometry
2
Description
Rotator cuff strength
Timepoint
Before the intervention, 1,3,6 months after intervention
Method of measurement
Muscle Manual Test
Intervention groups
1
Description
Intervention group1: Accupuncture group are needled in accupuncture points in shoulder , 20 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes
Category
Treatment - Devices
2
Description
Intervention group2: Sham accupuncture group are needled in accupuncture points in shoulder ,With distance 20 centimeter of main points ,10 millimeter deep inside the skin ,3 sessions a week for 10 session .each session is 10 minutes
Category
Treatment - Devices
3
Description
Control group: In exercise group , streching exercise for shoulder ,isometric exercises and passive range of motion each session 3 set 10 repetition daily and strengthening exercises and progressive strengthening exercises ,each session 3 set 10 repetition daily for 6 weeks.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iran university of medical sciences, Rasool hospital,sports medicine clinic
Full name of responsible person
Parisa Nejati
Street address
Sattarkhan, Niayesh st.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 6435 2446
Email
parisanejati2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Abbas Motevalian
Street address
Iran University of Medical Sciences, Near the Milad Tower, Hemmat Highway
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 86701
Email
amotevalian@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool hospital, Niayesh st.
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
parisanejati2@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
parisanejati@iums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Parisa Nejati
Position
Associate professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
Rasool hospital, Niayesh street, Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6651 5001
Email
parisanejati2@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