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IRCT20121228011912N10 IRCT 2026-10-23 Mashhad University of Medical Sciences Effect of Manual Acupuncture, Embedding Acupuncture, and Laser Acupuncture on Improving Fatigue and Metabolic Status in Patients with Hypothyroidism “Efficacy of Manual Acupuncture, Thread Embedding and Laser Acupuncture Combined with Levothyroxine on Fatigue and Selected Inflammatory and Metabolic Parameters in Hypothyroid Patients” 2027-02-20 anticipated 100 Pending https://irct.ir/trial/91316 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Other design features: This is a 4-arm randomized controlled trial featuring a synergistic design that investigates the combined efficacy of Acupoint Embedding Therapy (AET) and Low-Level Laser Therapy (LLLT) in patients with hypothyroidism. The use of AET as a primary intervention—facilitating sustained stimulation of acupuncture points—serves as the distinctive feature of this protocol compared to conventional acupuncture trials. This multidimensional approach concurrently evaluates biochemical markers and patient-reported outcomes (PROs). While complete blinding of the practitioner and patient is not feasible due to the nature of the interventions, we employ a rigorous blinding protocol for outcome assessors, laboratory personnel, and data analysts to minimize bias. The study adheres to a strictly standardized protocol for point selection and laser dosimetry to ensure high reproducibility, Randomization description: The study is a randomized controlled trial with the unit of randomization being the individual participant. We will use a block randomization method with variable block sizes of 4 and 6 (allocation ratio 1:1:1:1). The randomization sequence will be generated using the Randomization.com website by an independent researcher not involved in recruitment or data collection. Stratified randomization is not applied in this study. To ensure allocation concealment, we will employ the Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) technique. Upon verifying eligibility criteria and obtaining informed consent, the researcher will open the envelopes in numerical order to reveal the assigned group, Blinding description: Due to the nature of physical interventions and distinct procedural differences among study arms (manual acupuncture, catgut embedding, laser acupuncture, and standard pharmacotherapy), blinding of participants and the interventionists (acupuncturists) is not feasible. However, blinding is strictly implemented for outcome assessment and statistical analysis: Outcome Assessors: All follow-up evaluations and questionnaire assessments are conducted by an independent research assistant blinded to group allocation. Laboratory Personnel: Laboratory staff analyzing biochemical samples (thyroid profiles) are completely blinded to the allocated interventions, and samples are identified solely by unique alphanumeric codes. Data Analyst / Statistician: Statistical analysis is performed by an independent biostatistician with treatment arms coded as masked groups (e.g., Groups A, B, C, D), and unblinding will occur only after the final statistical analysis is finalized. 3 Hypothyroidism - Fatigue - Acupuncture - Acupoint Thread-Embedding - Laser Acupuncture. Intervention 1: Intervention group 1: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will undergo manual acupuncture. The intervention consists of 12 sessions (two sessions per week for 6 weeks). In each session, sterile disposable needles with dimensions of 0.25 by 40 mm (manufactured by SMC Acupuncture Needle Co.) will be inserted into selected acupuncture points and retained for 30 minutes. Intervention 2: Intervention group 2: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will undergo thread embedding therapy. This intervention consists of a single session of embedding absorbable polydioxanone (PDO) surgical threads (size 0) into selected acupuncture points. The continuous stimulatory and therapeutic effect of these threads will persist in the targeted points for 4 to 6 weeks. Intervention 3: Intervention group 3: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will receive laser acupuncture therapy. This intervention consists of 12 sessions (two sessions per week for 6 weeks). In each session, laser irradiation will be applied to the selected acupuncture points using a specific wavelength and a specialized laser probe. Intervention 4: Control group: Patients in this group will only receive standard medical treatment consisting of levothyroxine tablets (1.7 mcg/kg/day) adjusted to maintain thyroid-stimulating hormone levels within the normal range (0.35 to 3.5 mIU/L). The dosage is adjusted based on periodic laboratory tests, and no auxiliary interventions such as manual acupuncture, thread embedding, or laser acupuncture will be performed. Yes - There is a plan to make this available What will be shared: در مقاله ای که منتشر شود جزیات آماری داده ها ذکر می گردند. When: بعد از اتمام طرح To whom: تمام کسانی که به مقاله منتشره دسترسی یابند یا با مجوز نظارتی معاونت پژوهشی دانشگاه علوم پزشکی مشهد Conditions: با اجازه محقق مسئول و موافقت شورای پژوهشی دانشگاه و تنها به منظور استطلاعی بدون هرگونه امکان بهره برداری از محتوای داده ها. Where to obtain: بعد از چاپ مقاله به نویسنده مسئول و قبل از چاپ در صورت نیاز توسط مبادی ذیربط به محقق مسئول. How to obtain: از طریق معاونت پژوهشی دانشگاه Comments:
public Masoumeh Zibandeh Gorji
Acupuncture Clinic, Imam Reza Hospital Educational and Research Center, University Street, Mashhad, Khorasan Razavi, Iran
mashhsd Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2035 zibandehm4031@mums.ac.ir Mashhad University of Medical Sciences scientific Dr.Hamidreza Bahrami Taghanaki
Acupuncture Clinic, Imam Reza Hospital Educational and Research Center, University Street, Mashhad, Khorasan Razavi, Iran
mashhad Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3802 2035 bahramihr@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Age range of 18 to 65 years. Diagnosis of primary hypothyroidism confirmed by medical history, patient records, or specialist assessment. Receiving standard levothyroxine therapy for at least 3 months prior to study enrollment. Stable dosage of levothyroxine for at least 6 to 8 weeks prior to enrollment. Documented euthyroid status with TSH levels within the normal range (0.35–3.5 mIU/L) in the past 3 months. Fatigue Severity Scale (FSS) score ≥ 4 (indicating significant clinical fatigue). Willingness and ability to attend scheduled treatment sessions and follow-up assessments. Agreement to refrain from initiating any new complementary or alternative therapies related to fatigue or thyroid condition during the study period. Ability to read, understand, and complete the Persian-language study questionnaires. Provision of written informed consent to participate in the research. 18 years 65 years Both Secondary or central hypothyroidism (due to pituitary or hypothalamic disease). History of thyroid surgery due to thyroid cancer. Pregnancy or lactation. Severe acute or chronic medical conditions that could significantly affect fatigue levels or inflammatory markers, including: - Active systemic inflammatory diseases - Acute clinical infections - Clinically significant anemia - Active autoimmune disorders - Active malignancies - Severe cardiac, hepatic, or renal insufficiency - Uncontrolled psychiatric disorders (e.g., severe major depressive disorder or severe anxiety disorders) capable of causing significant fatigue. Concurrent use of medications that significantly influence fatigue, systemic inflammation, or metabolic rate, such as: - Systemic corticosteroids - Immunosuppressive agents - Central Nervous System (CNS) stimulants - New or recently initiated antidepressant medications. Any dosage adjustment of levothyroxine within the past 6 to 8 weeks prior to study enrollment. Pregnancy occurring during the study or planning to become pregnant during the follow-up period (for female participants of childbearing potential). Initiation of new medications affecting fatigue, inflammation, metabolism, or thyroid function (e.g., systemic corticosteroids, immunosuppressants, new antidepressants, weight-loss drugs, lipid-lowering agents, or drugs interfering with levothyroxine absorption/metabolism). Failure to complete the primary study questionnaires or scheduled laboratory evaluations at the designated time points. Serious protocol violation or persistent non-cooperation by the patient, at the discretion of the principal investigator. E03 Other hypothyroidism Treatment - Other Treatment - Other Treatment - Other Other Intervention group 1: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will undergo manual acupuncture. The intervention consists of 12 sessions (two sessions per week for 6 weeks). In each session, sterile disposable needles with dimensions of 0.25 by 40 mm (manufactured by SMC Acupuncture Needle Co.) will be inserted into selected acupuncture points and retained for 30 minutes. Intervention group 2: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will undergo thread embedding therapy. This intervention consists of a single session of embedding absorbable polydioxanone (PDO) surgical threads (size 0) into selected acupuncture points. The continuous stimulatory and therapeutic effect of these threads will persist in the targeted points for 4 to 6 weeks. Intervention group 3: Patients in this group, in addition to receiving standard medical treatment with levothyroxine (1.7 mcg/kg/day), will receive laser acupuncture therapy. This intervention consists of 12 sessions (two sessions per week for 6 weeks). In each session, laser irradiation will be applied to the selected acupuncture points using a specific wavelength and a specialized laser probe. Control group: Patients in this group will only receive standard medical treatment consisting of levothyroxine tablets (1.7 mcg/kg/day) adjusted to maintain thyroid-stimulating hormone levels within the normal range (0.35 to 3.5 mIU/L). The dosage is adjusted based on periodic laboratory tests, and no auxiliary interventions such as manual acupuncture, thread embedding, or laser acupuncture will be performed. Fatigue score measured by the FSS questionnaire. Timepoint: At baseline (before the intervention), at week 6 (end of the intervention), and 12 weeks after completion of the interventions. Method of measurement: Measurement of fatigue score using the Fatigue Severity Scale questionnaire. Serum thyroid stimulating hormone level(TSH). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Blood test for measurement of serum thyroid stimulating hormone level. Neutrophil to lymphocyte ratio(NLR). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Complete blood count and calculation of neutrophil to lymphocyte ratio. Platelet to lymphocyte ratio(PLR). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Complete blood count and calculation of platelet to lymphocyte ratio. Systemic immune inflammation index(SII). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Complete blood count and calculation of systemic immune inflammation index. Fasting blood sugar(FBS). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Fasting blood test for measurement of blood sugar level. Blood lipid profile. Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Fasting blood test for measurement of total cholesterol, triglyceride, high density lipoprotein, and low density lipoprotein. Triglyceride glucose index(TyG). Timepoint: Before intervention, six weeks after the start of the intervention, and twelve weeks after the end of the intervention. Method of measurement: Calculation of triglyceride glucose index based on fasting blood sugar and triglyceride values. Mashhad University of Medical Sciences Mashhad University of Medical Sciences Mashhad University of Medical Sciences Approved 2026-10-19 Imam Reza Hospital, Educational, Research, and Treatment Center - Mashhad University of Medical Scie Imam Reza Hospital Educational and Research Center, University Street, Mashhad, Khorasan Razavi, Iran mashhad Razavi Khorasan Iran (Islamic Republic of)