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IRCT20230204057316N1 IRCT 2023-04-21 Mashhad University of Medical Sciences Effects of face and body acupuncture on frown lines in women aged 30-59 years 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 2023-07-02 anticipated 72 Complete https://irct.ir/trial/68408 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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.), 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 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. N/A Wrinkles and aging of the facial skin. Intervention 1: 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). Intervention 2: 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. http://dx.doi.org/10.1111/jocd.70144 ABSTRACT Background: As life expectancy rises, facial rejuvenation has gained significance. Aims: This study aimed to evaluate the effects of body and facial acupuncture on reducing frown lines in women aged 30–59 in Mashhad, Iran. Patients/Methods: In this double-arm randomized wait-list controlled trial, 72 participants were randomly assigned to either an intervention group, receiving facial and body acupuncture twice weekly for 6weeks, or a control group with no treatment. The primary outcome was assessed using the Global Aesthetic Improvement Scale (GAIS) based on standardized photographs. Secondary outcomes included the Subject Satisfaction Scale (SSS) and Quality of Life (QOL) scores. Measurements were taken at three time points: week 0 (pre-treatment), week 7 (post-treatment), and week 12 (follow-up). Results: At week 7, 63% of the intervention group showed reduced frown lines at rest, and 72% during maximum frowning, significantly outperforming the control group. The improvements observed in the intervention group persisted at week 12 with 68.6% at rest and 57.2% at maximum frown. The SSS indicated that 72.2% and 62.9% of the intervention group were satisfied with their frown lines at weeks 7 and 12, respectively. Notable QOL improvements in social functioning were observed in the inter vention group compared to the control group at both weeks 7 and 12. No serious adverse effects were reported; minor bleeding occurred in 4.86% of treatment sessions, resulting in bruising in 0.69%. Conclusion: This study demonstrates that facial and body acupuncture is an effective and safe method for reducing frown lines. Trial Registration: IRCT20230204057316N1 (https://irct.behdasht.gov.ir/trial/68408) Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public Hossein Haghir
Department of Anatomy and Cell Biology, School of Medicine, Ground floor, East Entrance of the University campus, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2488 haghirh@mums.ac.ir Mashhad University of Medical Sciences scientific Hoda Azizi
Department of Acupuncture, School of Persian and Complementary Medicine, East Entrance of the University campus, Azadi square
Mashhad Iran (Islamic Republic of) 9177899191 +98 51 3884 8931 azizih@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 30-59-year-old females Suffered from frown lines Having informed consent to participate in the study 30 years 59 years Female 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 L57.9 Skin changes due to chronic exposure to nonionizing radiation, unspecified Treatment - Other Other 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). 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. 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. 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. 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). 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. Mashhad University of Medical Sciences Approved 2023-04-07 Ethics commitee of Mashhad University of Medical Sciences Research chancellor of Mashhad University of Medical Sciences, 2nd floor, Ghoreishi Building, Daneshgah Street Mashhad Razavi Khorasan Iran (Islamic Republic of)