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IRCT20260811070621N1 IRCT 2026-10-22 Ahvaz University of Medical Sciences Comparison of the Additive Effect of Acupuncture Combined with Extracorporeal Shock Wave Therapy Versus Shock Wave Therapy Alone in the Treatment of Plantar Fasciitis Comparison of the Additive Effect of Acupuncture Combined with Extracorporeal Shock Wave Therapy Versus Shock Wave Therapy Alone in the Treatment of Plantar Fasciitis : a clinical trial study 2026-08-31 anticipated 74 Recruiting https://irct.ir/trial/92501 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The allocation sequence will be generated using permuted block randomization with a block size of 4 and a 1:1 allocation ratio between the intervention and control groups. This process will be carried out using SPSS software by an independent statistician who is not involved in participant enrollment, assessment, or intervention delivery; the allocation list will not be disclosed to the principal investigators until the study concludes. To ensure allocation concealment, sequentially numbered, opaque, sealed envelopes will be used. These envelopes will be prepared by an independent individual and stored in a secure location. Upon the enrollment of an eligible participant—and only after confirming inclusion criteria and obtaining informed consent—the envelope corresponding to the next sequence number will be opened by an individual not involved in outcome assessment or intervention delivery to reveal the assigned group. This process ensures that both researchers and participants remain unaware of the group assignment until the moment of allocation, Blinding description: Following the acquisition of written informed consent and the patient's enrollment in the study, individuals are assigned to one of two groups—either the intervention group (routine shockwave therapy plus acupuncture) or the routine treatment group (shockwave therapy)—using a random number table. The randomization process is double-blind; participants, those assigning individuals to groups, and outcome assessors (the treating physician) remain completely unaware of the group allocations. Blinding is achieved through the use of opaque, sealed envelopes, each containing a unique code designating either the intervention or control group. Upon enrollment, each participant is assigned an envelope that determines their group placement. To implement the treatment protocol, Individual A administers shockwave therapy to all patients, while Individual B treats a subset of patients based on acupuncture groupings; consequently, Individual A—the physician in charge of the study—is blinded. The individuals responsible for data collection and statistical analysis, the person drafting the manuscript, and the data monitoring committee are also blinded, as they remain unaware of the defined codes. 3 plantar fasciitis. Intervention 1: Intervention group: shockwave therapy. Intervention 2: Intervention group: shockwave+ acupuncture. 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 Haven t decided yet
public Atieh Lal Vazifeh
Golestan
َAhvaz Iran (Islamic Republic of) 6135718765 +98 915 218 5518 atieh.l.vazifeh@gmail.com Ahvaz University of Medical Sciences scientific Seyed Reza Saeidian
Azadegan
Ahvaz Iran (Islamic Republic of) 613564236 +98 916 111 2778 seyedrezasaeidian@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Plantar fasciitis (pain in the sole of the foot—particularly in the morning) patients who have suffered from this pain for a month. no limit no limit Both Inflammatory diseases such as rheumatoid arthritis; A history of direct trauma—with or without fracture of the metatarsal bones A history of injections into the plantar fascia Incomplete shockwave therapy within at least the past two months Incomplete acupuncture within at least the past two months Pregnancy M72.2 Plantar fascial fibromatosis Treatment - Devices Treatment - Devices Intervention group: shockwave therapy Intervention group: shockwave+ acupuncture Comparison of the additive effect of acupuncture to shockwave therapy versus shockwave therapy alone in the treatment of plantar fasciitis: A clinical trial. Timepoint: Before treatment, immediately after treatment (2 weeks), and 4 weeks after the start of treatment. Method of measurement: Foot and Ankle Disability Index (FADI) and VAS questionnaire form. Ahvaz University of Medical Sciences Approved 2026-08-31 Ethics committee of Ahvaz University of Medical Sciences Ethics Committee, Ahvaz University of Medical Sciences, Golestan Highway Ahvaz Khouzestan Iran (Islamic Republic of)