Evaluation of effectiveness of Ghamz and Dalk On chronic neck pains
Design
The clinical trial of the effect of traditional massage on 32 patients with chronic neck pain. (Before & After Clinical Trial without control group, not randomized, not blinded)
Settings and conduct
In this clinical trial, patients with chronic neck pain who are referred to the traditional medical school of Iran University of Medical Sciences are selected.
Measurement method was based on NDI, NPDS Questionnaires, Visual Analog Scale (VAS), Quality of Life Questionnaire and Digital goniometer (to measure neck movements).
Follow up of these patients is in 3 stages (before the first intervention, after the end of the session and one month after the intervention).
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Age of 18 to 70 years ; Pain in the neck more than three months
Exclusion Criteria: Upper limb neurological symptoms; Every damage to the nerves or under the pressure of the spinal cord; History of fracture and dislocation on the neck region;Taking anticoagulants such as Warfarin; Peripheral nerve lesions and malignancy and cancer in the neck area; Fever and severe headache and meningitis symptoms
Intervention groups
The release of spasms with the help of technique "Ghamz and dalk": the volunteering group is placed under the massage (Ghamz and Dalk), which are designed by the researcher. This procedure is performed for 10 minutes and in 4 sessions for four weeks.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20171111037368N2
Registration date:2018-03-11, 1396/12/20
Registration timing:prospective
Last update:2018-03-11, 1396/12/20
Update count:0
Registration date
2018-03-11, 1396/12/20
Registrant information
Name
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 77469291
Email address
khoramizadeh.m@tak.iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-21, 1397/01/01
Expected recruitment end date
2018-05-22, 1397/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effectiveness of one type of Iranian traditional massage (Dalk and Ghamz) On chronic neck pains
Public title
Effect of Iranian traditional massage on chronic neck pains
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Informed consent
Age of 18 to 70 years
Pain in the neck
More than three months from the onset of pain in the neck (continuous or alternating)
Disrupting some routine tasks
Exclusion criteria:
Upper limb neurological symptoms
Severe psychiatric illnesses
Pregnancy
Any damage to the nerves or under the pressure of the spinal cord
A report on pathology and neck surgery and cancer
History of fracture and dislocation on the neck region
History of severe cervical disorder such as a herniated disc
Hemophilia
Diabetic neuropathy
Epilepsy
Deep venus thrombosis
Anaphylaxis
Taking anticoagulants such as Warfarin
There is a scar on the neck
Peripheral nerve lesions and malignancy and cancer in the neck area
Fever and severe headache and meningitis symptoms
Patients who have not completed their treatment sessions
Patient dissatisfaction
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
32
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
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
No.1, Mansouri alley, prayer street, Sattar Khan street
City
Tehran
Province
Tehran
Postal code
۱۴۴۵۶۱۳۱۱۱
Approval date
2017-10-28, 1396/08/06
Ethics committee reference number
IR.IUMS.FMD.REC 1396.9321309002
Health conditions studied
1
Description of health condition studied
Neck Pain With Mobility Deficits
ICD-10 code
M54.2
ICD-10 code description
Cervicalgia
2
Description of health condition studied
Neck Pain With Mobility Deficits
ICD-10 code
M54.6
ICD-10 code description
Pain in thoracic spine
3
Description of health condition studied
Neck Pain With Headache
ICD-10 code
R51
ICD-10 code description
Headache
4
Description of health condition studied
Neck Pain With Movement Coordination Impairment
ICD-10 code
S13.4
ICD-10 code description
Sprain of ligaments of cervical spine
5
Description of health condition studied
Neck Pain With Radiating Pain
ICD-10 code
M50.1
ICD-10 code description
Cervical disc disorder with radiculopathy
Primary outcomes
1
Description
Neck Pain
Timepoint
Before and after each intervention (first, one, two, three weeks later), one month after the last intervention
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
The range of motion in the neck and shoulders
Timepoint
Before and after each intervention (first, one, two, three weeks later), one month after the last intervention
Method of measurement
Goniometer
2
Description
Neck Disability
Timepoint
Start of intervention, at the end of the intervention (fourth session), one month after the end of the intervention
Method of measurement
Neck disability index questionnaire & neck pain and disability scale scoring questionnaire
3
Description
Quality of life score
Timepoint
Start of intervention, at the end of the intervention (fourth session), one month after the end of the intervention
Method of measurement
Quality of life questionnaire SF-36
Intervention groups
1
Description
The selection of the patient to enter the study is among the patients with neck pain that has criteria for entry. Initially, the individual patient information and disease characteristics (duration, symptoms, accompanying illnesses, treatments, medications, etc.) and patient records are reviewed. The procedure for entering patients is twofold: the first group of patients who have already been fully evaluated by the specialist for reasons of cervical pain and who do not have exclusion criteria and who do not need a re-examination by a physician. And will be directly included in the study by the researcher himself. The second group of patients who do not have the necessary examinations should first be examined by a physical therapist and then enter the study. After describing the goals and method of work and signing the written consent of the patient, the intervention on the patient is done as follows: 1. Preparation: The patient is sitting at the edge of the bed (hanging legs) and the massager stays in front of the patient and The head, neck and shoulders are covered with scarves or thin linen. 2. Determining the location of massage : Locating spasms by the patient, showing the patient's location of pain and spasm to the massager . Determine the location of spasms by the massager: Massage areas can be identified by seeing more prominent areas or the amount of movement restrictions in the neck and shoulders area or touching the painful areas and more prominent (with disposable gloves and without using oil at the tip of the first, second and third fingers). 3. The release of spasms with the help of technique "Ghamz and Dalk" . Ghamz techniques : At this stage, we stimulate the location of spasms with the help of fingertips in a transverse direction relative to the muscle path, from 5 to 10 times depending on the patient's tolerance. Dalk Technique: At this stage, massage is done with the help of finger tips in the longitudinal direction of the muscle, 5 to 10 times from the top down and from the posterior to the front. The duration of massage per session is ten minutes. The number of sessions, four sessions, and intervals of one week. The limitation of movement in the neck area will be evaluated before and after each intervention by a digital goniometer . Also, the rate of neck disability and quality of life of the patient will be evaluated before the intervention, the end of the intervention and one month after the last intervention.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
School of persian medicine
Full name of responsible person
Mansour khoramizadeh
Street address
No. 847 , Behesht Street Beginning , the south side of City Park , Vahdat-e-Islami St , Hassan Abad Square , School of persian medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
khoramizadeh.m@tak.iums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Sayed Kazem Malekoti
Street address
Hemat Highway next to Milad Tower, Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
۱۴۴۹۶۱۴۵۳۵
Phone
+98 21 8670 2503
Email
Malakoutik@gmail.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
Mansour Khoramizadeh
Position
Ph.D. Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
Traditional Medicine
Street address
No. 847 , Behesht Street Beginning, the south side of City Park, Vahdat-e-Islami St, Hassan Abad Square, School of persian medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
khoramizadeh.m@tak.iums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Hoorieh Mohammadi Kenari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Traditional Medicine
Street address
No. 847 , Behesht Street Beginning , the south side of City Park, Vahdat-e-Islami St, Hassan Abad Square, School of Persian Medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5563 9667
Email
hmk1358@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mansour Khoramizadeh
Position
Ph.D. Student of Traditional Medicine
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No. 847 , Behesht Street Beginning , the south side of City Park , Vahdat-e-Islami St , Hassan Abad Square , School of persian medicine
City
Tehran
Province
Tehran
Postal code
۱۱۱۴۷۳۳۳۱۱
Phone
+98 21 5558 0388
Fax
+98 21 8800 2651
Email
khoramizadeh.m@tak.iums.ac.ir
Web page address
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