1
Clinical Trial Protocol
Iranian Registry of Clinical Trials
05 Nov 2022
Evaluation of Ghamz and its Applications in Iranian Traditional Medicine Resources and Evaluation of Ghamz Effect on Pain and Shoulder Function in People with Chronic Shoulder Pain
Protocol summary
Study aim
The effect of Ghamz on shoulder pain and function in patients with chronic shoulder pain
Design
Parallel group randomized controlled clinical trial Settings and conduct
70 patients aged 18-60 years with chronic shoulder pain who have acute problems that do not require emergency procedures such as surgery, are volunteered after obtaining consent. After a randomization, a group treated with a traditional medicine called Ghamz . This intervention is performed for a period of 4 weeks( There is a treatment session every week), which lasts for 10 to 15 minutes each treatment session.The control group is in the waiting list without any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: • Informed consent • Age 18 - 60 years
• Chronic pain in the shoulder (more than 4 months) Exclusion criteria : • The severity of pain is such that there is a need for other treatments • Use of other therapeutic interventions within the last 3 months (only oral analgesic is allowed) • Complete rupture of the rotator cuff • Hemophilia, epilepsy, DVT, anaphylaxis • Neurological signs of the upper extremity and signs of pressure on the roots of the cranial nerves • Severe psychiatric illnesses • Pregnancy • History of surgery, blow, fracture or dislocation in the shoulder • The use of anticoagulants such as warfarin • Insulin-dependent diabetes
Intervention groups
"Ghamz" is a deep massage. The therapist pushes the nerves, tendons and muscle tissue deeply with his fingers. Routine rehabilitation interventions such as massage and heat are performed in the control group.
Main outcome variables Shoulder pain and function
General information
Reason for update
The recruitment end date and the trial completion date were updated. The shoulder's range of motion was added to the outcomes. The primary and secondary outcomes were corrected. The recruitment center was changed. In order to investigate the effects of ghamz alone, the recommendation to exercise at home was removed. The duration of the intervention was changed from 15 minutes to 10 to 15 minutes.
Acronym
IRCT registration information
IRCT registration number: IRCT20171218037941N1 Registration date: 2018-10-13, 1397/07/21
Registration timing: registered_while_recruiting
Last update: 2022-04-27, 1401/02/07 Update count: 2
Registration date 2018-10-13, 1397/07/21 Registrant information
Name
Fatemeh Behdad
Name of organization / entity Country
Iran (Islamic Republic of) Phone
+98 21 5560 1274 Email address
[email protected] Recruitment status
Recruitment complete Funding source
Expected recruitment start date 2018-09-23, 1397/07/01
2 Expected recruitment end date
2019-03-21, 1398/01/01 Actual recruitment start date
2018-09-23, 1397/07/01 Actual recruitment end date
2019-04-28, 1398/02/08 Trial completion date
2019-04-28, 1398/02/08 Scientific title
Evaluation of Ghamz and its Applications in Iranian Traditional Medicine Resources and Evaluation of Ghamz Effect on Pain and Shoulder Function in People with Chronic Shoulder Pain
Public title
"Ghamz" shoulder pain Purpose
Treatment
Inclusion/Exclusion criteria Inclusion criteria:
chronic shoulder pain(More than 4 months) Informed consent Age of 18 to 60 years
Exclusion criteria:
The severity of the pain is such that there is a need for other treatments. Use of other therapeutic interventions during the last 3 months (only oral analgesic is allowed).
Full rotator cuff rupture Hemophilia, Epilepsy, DVT, Anaphylaxis • Neurological signs of the upper limb and signs of pressure on the roots of the cranial nerves Severe mental illness Pregnancy History of surgery, trauma, fracture, or shoulder dislocation Anticoagulants such as warfarin Insulin-dependent diabetes
Age
From 18 years old to 60 years old Gender
Both Phase
2-3
Groups that have been masked No information
Sample size
Target sample size: 70
Actual sample size reached: 70
Randomization (investigator's opinion) Randomized
Randomization description
Randomization is done by block method. Random unit is the person. Four blocks of two interventions A, B are selected using the table of random numbers . The randomization list is based on A, B. Then the number of patients and their intervention are written on a paper and placed inside the envelope. Each patient chooses a closed envelope.
Blinding (investigator's opinion) Not blinded
Blinding description Placebo
Not used Assignment
Parallel
Other design features
Secondary Ids empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Hemat Highway, next to Milad Tower City
Tehran Province
Tehran Postal code
1449614535 Approval date
2017-11-18, 1396/08/27
Ethics committee reference number IR.IUMS.REC.1396.9321309009
Health conditions studied
1
Description of health condition studied chronic shoulder pain
ICD-10 code M25.519
ICD-10 code description Pain in unspecified shoulder
Primary outcomes
1
Description shoulder pain Timepoint
At the baseline, 1st, 2nd, 3rd, and 4th week of intervention, and 3rd month after the end of the intervention.
Method of measurement Visual analogue scale
Secondary outcomes
1
Description
Patients’ disability Timepoint
At baseline, 4th week of intervention, and 3rd month after the end of the intervention.
Method of measurement
Shoulder Pain and Disability Index
3
2
Description
shoulder’s range of motion Timepoint
At baseline, 4th week of intervention, and 3rd month after the end of the intervention.
Method of measurement goniometer
Intervention groups
1
Description
Intervention group: ghamz 4 times with intervals of one week.Each visit is done for 10-15 minutes.There is no need to equipment or medicine. And done with fingers.The first technique is GRAP: grab the armpit to get the nerve and ligaments of the site and then release them. Second technique: Poke: In this technique, the points are compressed by pressing the fingertips. This technique is done in the deltoid region and the sides of the arm.
Category
Treatment - Other
2
Description
Control group: patients in the waiting list without intervention
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Iranian Blood Transfusion Organization Full name of responsible person
Fatemeh Behdad Street address
Hemmat Exp., next to the Milad Tower, Tehran, Iran City
Tehran Province
Tehran Postal code
146651157 Phone
+98 21 8205 2246 Fax
+98 21 8860 1574 Email
Sponsors / Funding sources
1 Sponsor
Name of organization / entity Iran University of Medical Sciences Full name of responsible person
Kazem Malakuti Street address
Hemat Highway, next to Milad Tower City
Tehran Province
Tehran Postal code
۱۴۴۹۶۱۴۵۳۵ Phone
+98 21 8670 1021 Email
[email protected] 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
Fatemeh Behdad Position
Phd student Latest degree
Medical doctor
Other areas of specialty/work Traditional Medicine
Street address
Tehran, Hassan Abad Square, Vahdat-e-Islami St., South side of Park City, Behesht Street, 847, Faculty of Traditional Medicine
City Tehran Province
Tehran Postal code
۱۱۱۴۷۳۳۳۱۱ Phone
+98 21 5560 1274
4 Fax
Person responsible for scientific inquiries
Contact
Name of organization / entity Iran University of Medical Sciences Full name of responsible person
Fatemeh Behdad Position
Phd student Latest degree
Medical doctor
Other areas of specialty/work Traditional Medicine
Street address
Tehran, Hassan Abad Square, Vahdat-e-Islami St., South side of Park City, Behesht Street, 847, Faculty of Traditional Medicine
City Tehran Province
Tehran Postal code
۱۱۱۴۷۳۳۳۱۱ Phone
+98 21 5560 1274 Fax
Person responsible for updating data
Contact
Name of organization / entity Iran University of Medical Sciences Full name of responsible person
Fatemeh Behdad Position
Phd student Latest degree
Medical doctor
Other areas of specialty/work Traditional Medicine
Street address
Tehran, Hassan Abad Square, Vahdat-e-Islami St., South side of Park City, Behesht Street, 847, Faculty of Traditional Medicine
City Tehran Province
Tehran Postal code
۱۱۱۴۷۳۳۳۱۱ Phone
+98 21 5560 1274 Fax
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
Not applicable Data Dictionary Not applicable
Title and more details about the data/document The SPSS file without the name of the participants is sharable.
When the data will become available and for how long
After publishing the article for 1 year To whom data/document is available
Academic researchers
Under which criteria data/document could be used There is no limit to data analysis. Presentation of data to others is prohibited and the publication of the results of new analyzes is allowed only for meta-analysis.
From where data/document is obtainable via this email address: [email protected]
What processes are involved for a request to access data/document
the data will be sent via email one week after receiving the request.
Comments
