Effects of face and body acupuncture on glabellar frown lines in women aged 30-59 years referred to the dermatology or acupuncture clinics of Mashhad University of Medical Sciences
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General information
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72
72
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2023-07-02, 1402/04/11
2023-07-02 00:00:00
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2024-06-16, 1403/03/27
2024-06-16 00:00:00
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2024-09-15, 1403/06/25
2024-09-15 00:00:00
Protocol summary
Study aim
Determining the effects of facial and body acupuncture on the frown line in women aged 30-59 referring to dermatology or acupuncture clinics of Mashhad University of Medical Sciences.
Design
A Two-arm parallel (36 patients in each arm), randomized trial with blinded assessors and data analysts
Settings and conduct
Intervention group: The acupuncture points of the body and face, as well as the depth of the frown line, are needled. Needling is done twice a week for 6 weeks and the needles last for twenty minutes in each session. Patients are subjected to imaging of the glabella area three times including at the time of the first visit, one week and six weeks after the end of the last treatment session under standard conditions in two states of rest and maximum frown. Control group: These patients are subjected to imaging of the glabella region three times including at the time of the first visit, seven and twelve weeks after the first visit under standard conditions in two states of rest and maximum frown without any intervention.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 72 women aged 30-59 suffered from frown lines with informed consent.
Exclusion criteria: performing facial rejuvenation procedures in the glabella and forehead area in the last six months or during treatment; skin diseases, diabetes, and tuberculosis; anticoagulant or thrombolytic use; pregnancy or breastfeeding; history of herpes.
Intervention groups
Intervention group: face and body acupuncture and Control group: no treatment
Main outcome variables
The three images of each patient, in two states of rest and maximum frown, are scored and compared independently by three trained physicians (outside of the research team) using the Glabellar Line Scale (GLS) and by one of the researchers using the Global Aesthetic Improvement Scale (GAIS).
General information
Reason for update
Adding the item #10 to the exclusion criteria (which is already recorded in the Pajuhan's proposal and implemented in the study)
Acronym
IRCT registration information
IRCT registration number:IRCT20230204057316N1
Registration date:2023-04-21, 1402/02/01
Registration timing:prospective
Last update:2025-01-11, 1403/10/22
Update count:4
Registration date
2023-04-21, 1402/02/01
Registrant information
Name
Hossein Haghir
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 3800 2488
Email address
haghirh@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-02, 1402/04/11
Expected recruitment end date
2024-03-17, 1402/12/27
Actual recruitment start date
2023-07-02, 1402/04/11
Actual recruitment end date
2024-06-16, 1403/03/27
Trial completion date
2024-09-15, 1403/06/25
Scientific title
Effects of face and body acupuncture on glabellar frown lines in women aged 30-59 years referred to the dermatology or acupuncture clinics of Mashhad University of Medical Sciences
Public title
Effects of face and body acupuncture on frown lines in women aged 30-59 years
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
30-59-year-old females
Suffered from frown lines
Having informed consent to participate in the study
Exclusion criteria:
Patients who have undergone one of the dermabrasion methods, deep skin peeling, laser peeling (ablative or nonablative), botulinum toxin injection, filler injection, or topical steroid treatment in the glabella and forehead area within six months prior to referral
Patients with obvious skin disease or a history of chronic skin disease
Pregnant or lactating patients
Patients with a history of herpes
Patients with a history of skin allergy and needle or metal allergy
Patients with diabetes and tuberculosis
Patients receiving anticoagulant or thrombolytic therapy
Patients with serious systemic diseases (heart, lung, kidney...)
Using any other facial rejuvenation treatment during the course of acupuncture treatment
Not participating in more than two sessions or creating an interval of more than one week between acupuncture sessions
Age
From 30 years old to 59 years old
Gender
Female
Phase
N/A
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
72
Actual sample size reached:
72
Randomization (investigator's opinion)
Randomized
Randomization description
The randomization will be performed using the sealedenvelope website (www.sealedenvelope.com) to generate a randomization sequence. Using permuted block randomization method with block size of 4, the methodologist will generate the randomization sequence. Then the codes will be placed in sequentially numbered, opaque, sealed envelopes to ensure allocation concealment.
Blinding (investigator's opinion)
Double blinded
Blinding description
In the present study, it is not possible to mask the patients, however, the outcome assessors who are outside the research team are unaware of the group assigned to the participants. The data analyzer will be blinded to the assigned group of each patient using A and B codes in the datasheet.
Placebo
Not used
Assignment
Parallel
Other design features
The research team conducted an extensive search based on existing studies that show the superiority of "waiting list" over "sham control" in this research field; It has been decided to use the waiting list model in the present study. (Liu J, Li L, Luo X, Qin X, Zhao L, Zhao J, Zhou X, Liu Y, Deng K, Ma Y, Zou K. Specification of Interventions and Selection of Control in Acupuncture Randomized Controlled Trials: A Cross-Sectional Study.)
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Mashhad University of Medical Sciences
Street address
Research chancellor of Mashhad University of Medical Sciences, 2nd floor, Ghoreishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Approval date
2023-04-07, 1402/01/18
Ethics committee reference number
IR.MUMS.REC.1402.011
Health conditions studied
1
Description of health condition studied
Wrinkles and aging of the facial skin
ICD-10 code
L57.9
ICD-10 code description
Skin changes due to chronic exposure to nonionizing radiation, unspecified
Primary outcomes
1
Description
The frown line depth score on "Glabellar Line Scale (GLS)"
Timepoint
Images will be taken from the patients and evaluated in three sessions. The first appointment will be at the first visit (in both groups), the second appointment will be one week after the end of the last treatment session in the intervention group and seven weeks after the first appointment in the control group, and the third appointment will be six weeks after the second appointment in both groups.
Method of measurement
Photographs of patients' foreheads are performed using a Canon 5D Mark III (Japan) digital camera mounted on a tripod. The photography room has no windows (no outside light). The patient's chin is placed on a support. Light conditions are standardized using two photographic lamps that were placed at an angle of 45 degrees to each other and at 45 degrees above the patient's forehead. By choosing the center of the image as a point just above the glabellar region, the entire forehead is shown on the image. The side margins of the photos were set 2 cm lateral to the lateral corner of the eye. All patients were photographed without makeup at rest and during function (maximum frown). The frown line depth score is evaluated by three physicians (outside the research executive team) independently and the average score of these three evaluators will be calculated for each case. To ensure the validity of results, clinicians performing GLS assessments will receive GLS training. The frown line depth score on a 4-degree "Glabellar Line Scale (GLS)": 0 = no line, There is no frown line at rest and maximum frown. 1 = mild, There is no frown line at rest, but a subtle frown line can be seen at the maximum frown state. 2 = moderate, At rest there is a subtle frown line that becomes more pronounced at maximum frown. 3 = severe, At rest there is a clear frown line that deepens in maximum frown.
2
Description
Aesthetic improvement score on "Global Aesthetic Improvement Scale (GAIS)"
Timepoint
This evaluation will be done in two stages. In the first stage, the score of aesthetic improvement between the images of the second appointment compared to the images of the first appointment, and in the second stage the score of aesthetic improvement between the images of the third appointment compared to the second and first appointments will be evaluated in each patient.
Method of measurement
Evaluation by a research team member, blinded to the patients, is performed based on the difference in the frown line depth score between three times of photography (at rest and maximum frown) for each patient according to the Glabellar Line Scale (GLS). The Global Aesthetic Improvement score on a 5-point "Global Aesthetic Improvement Scale (GAIS)": (+2) much improved = improving at least two degrees or reaching the zero degree (no frown line). (+1) improved = one degree of improvement without reaching the zero degree. (0) no change = no change. (-1) worse = a degree of worsening. (-2) much worse = two degrees worse.
Secondary outcomes
1
Description
The general level score of satisfaction in participants
Timepoint
This assessment is done by the patient herself one week after the end of the last treatment session in the intervention group and seven weeks after the first visit in the control group.
Method of measurement
Self-evaluation using "Subject Satisfaction Scale" (A five-point scale: 2=very satisfied, 1=satisfied, 0=no difference, -1=unsatisfied, -2=very unsatisfied)
2
Description
The Score of the Quality of Life
Timepoint
This evaluation is done at the first visit and then one week after the end of the last treatment session in the intervention group and seven weeks after the first visit in the control group and compared with the results at the time of first visit.
Method of measurement
Using the 36-Item Short Form Survey (SF-36) questionnaire.
Intervention groups
1
Description
Intervention group: The acupuncture treatment protocol for the intervention group is reported according to the criteria for reporting interventions in clinical trials of acupuncture (STRICTA). Points used in body acupuncture: A) Calming points of the mind that relax and relax the muscles and thus reduce frown lines: DU 20, LIV 3, PC 6, and ST 36 B) Effective points in regulating skin moisture: SP 9, LI 4, and LU 7 C) Effective points in helping to blood supply of the skin, anti-itching and anti-dryness of the skin: LI 11 and SP 10. These points are bilaterally needled (except for DU 20 which is located in the midline) by needles with 25mm (length) × 0.25mm (thickness) size. The depth of the needle insertion will depend on the thickness of the skin and subcutaneous fat tissue at the needle insertion site and according to the acupuncture reference texts. All the above points are used for all patients, regardless of other signs and symptoms. The needling will be the same in all points and with the even method. First, the points on the lower limb, including LIV 3, ST 36, SP 9, and SP 10 are needled from the distal to the proximal end of the limb, respectively (first the on the right and then on the left lower limb). Then the points on the upper limb including LI 4, LU 7, PC6, and LI 11 are needled, respectively from the distal to the proximal end of the limb (first the on the right and then on the left upper limb). Finally, DU 20 will be needled in the vertex. The total number of needles used in the body is 17. Points used in the face: BL 2, Ex-HN4 (Yuyao), TB 23, and Ex-HN3 (Yintang) are bilaterally used (except Ex-HN3 which is in the midline) by needles with 13mm (length) x 0.18mm (thickness) size. The depth of the needle insertion will depend on the thickness of the skin and subcutaneous fat tissue at the needle insertion site and according to acupuncture references. All the above points are used for all patients, regardless of other signs and symptoms. The needling will be the same in all points and with the even method. First, Ex-HN3 is needled in the middle of the glabella and between the two eyebrows. Then, BL 2, Ex-HN4, and TB 23 are needled from the medial end toward the lateral end of the eyebrow (first on the right and then on the left side). The total number of needles used in the face is 7. Points used in the depth of the frown line: Finally, intradermal needles with a size of 5 mm (length) x 0.22 mm (thickness) are used in the depth of the frown line and with a distance of 2 mm from each other. These needles are inserted at an angle of 45 degrees to the skin in the depth of the groove. The direction of entering the needles is upwards. By inserting the needles intradermally in the area of the frown line, very small damage is caused to the skin. Then the body tries to repair this damage by producing collagen, and in this way, the frown line is gradually filled. The patient is lying on the bed in the supine position and a small pillow is placed under her head during the entire period of acupuncture. All the needles used in the body, face, and frown line are made by Huanqiu (China), which remain in the patient's body for twenty minutes in each treatment session and are then removed. If there is bleeding and possible bruising after removing the needle, Arnica ointment and an ice pack are used. The total number of acupuncture sessions will be 12 sessions and acupuncture will be done twice a week for 6 weeks by an experienced therapist (14 years of experience).
Category
Treatment - Other
2
Description
Control group: The control group will be monitored for six weeks without any intervention and on a waiting list. At the end of the research (after the third appointment of imaging) and as a reward, the people of this group will also undergo acupuncture treatment according to the protocol of the intervention group.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Acupuncture Clinic of Mashhad University of Medical Sciences
Full name of responsible person
Hoda Azizi
Street address
Acupuncture clinic, 2nd floor, Imam Reza Hospital- west side, ِDaneshgah street (against Kafai street)
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2391
Email
azizih@mums.ac.ir
2
Recruitment center
Name of recruitment center
Dermatology Clinic of Mashhad University of Medical Sciences
Full name of responsible person
Mohammad Javad Yazdanpanah
Street address
Dermatology clinic, 1st floor, Imam Reza Hospital- west side, ِDaneshgah street (against Kafai street)
City
Mashhad
Province
Razavi Khorasan
Postal code
9137913316
Phone
+98 51 3802 2144
Email
yazdanpanahmj@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Majid Ghayour-Mobarhan
Street address
Research chancellor of Mashhad University of Medical Sciences, 2nd floor, Ghoreishi Building, Daneshgah Street
City
Mashhad
Province
Razavi Khorasan
Postal code
9138813944
Phone
+98 51 3841 1538
Email
ghayourm@mums.ac.ir
Grant name
Grant code / Reference number
4011855
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad 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
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Haghir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Anatomy and Cell Biology, School of Medicine, Ground floor, East Entrance of the University campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2488
Email
haghirh@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hoda Azizi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Acupuncture
Street address
Department of Acupuncture, School of Persian and Complementary Medicine, East Entrance of the University campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177899191
Phone
+98 51 3884 8931
Email
azizih@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Hossein Haghir
Position
Professor
Latest degree
Ph.D.
Other areas of specialty/work
Anatomy
Street address
Department of Anatomy and Cell Biology, School of Medicine, Ground floor, East Entrance of the University campus, Azadi square
City
Mashhad
Province
Razavi Khorasan
Postal code
9177948564
Phone
+98 51 3800 2488
Email
haghirh@mums.ac.ir
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