Study aim:
To assess the effectiveness of different acupuncture methods (manual, laser, acupoint embedding) combined with standard medication in reducing fatigue and improving specific biochemical markers in hypothyroidism patients.
Design:
This is a Phase III, four-arm, single‑blinded(assessor and analyst) randomized clinical trial involving 100 patients.
Randomization: Permuted block randomization (blocks of 4 and 6), with allocation concealment via SNOSE envelopes.
Arms:
Manual Acupuncture (MA) + Levothyroxine (LT4): 2 times/week for 6 weeks
Acupoint Embedding (AET) + LT4: 1 session
Laser Acupuncture (LA) + LT4: 2 times/week for 6 weeks
Control: LT4 only.
Settings and conduct:
Study Type: Phase III, randomized, four-arm clinical trial.
Location: Acupuncture Clinic of Imam Reza Hospital, Mashhad, Iran.
Patients: 100 patients with hypothyroidism.
Randomization: Permuted block randomization method, SNOSE envelopes.
Groups: MA, AET, LA, control (Levothyroxine only).
Intervention Period: 6 weeks.
Blinding: Assessors, laboratory personnel, statistical analysts blinded. Patients and practitioners not blinded.
Participants/Inclusion and exclusion criteria:
Age 18-65, primary hypothyroidism, stable levothyroxine, normal TSH, severe fatigue (FSS≥4).
Commitment to protocol and consent
/
Secondary/central hypothyroidism, history of thyroid cancer, pregnancy/lactation.
Severe illnesses, specific medications (steroids, immunosuppressants...).
Recent levothyroxine dose change, recent acupuncture/embedding/laser therapy.
Coagulation/anticoagulation issues, skin problems, non-compliance.
Intervention groups:
MA + Standard: 12 MA sessions over 6 weeks + Levothyroxine
AET + Standard: 1 single AET session + Levothyroxine
LA + Standard: 12 LA sessions over 6 weeks + Levothyroxine
Control: Levothyroxine only
Main outcome variables:
Primary : Mean change in FSS
Secondary: TSH, T4, NLR, PLR, SII, lipid profile, TyG , FBS, QoL
IRCTID: IRCT20121228011912N10