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

Determining the additive effect of acupuncture combined with shockwave therapy versus shockwave therapy alone in the treatment of plantar fasciitis; and comparing pain and disability levels—measured before treatment, immediately after treatment (at 2 weeks), and four weeks after the start of treatment—between the shockwave-only method and the combined shockwave and acupuncture approach.

Patients presenting with sole-of-the-foot pain persisting for more than one month will be referred to the Physical Medicine Department at the Ahvaz University of Medical Sciences medical center; the diagnosis of plantar fasciitis will be confirmed through clinical and/or radiological evaluations. Following initial assessments, 74 patients—selected based on inclusion and exclusion criteria—will be assigned via a random number table (using a double-blind randomization method) to one of two groups: one receiving shockwave therapy and the other receiving a combination of shockwave therapy and acupuncture. Instruments to be used: FADI and the VAS questionnaire.

Physical Medicine Department, Ahvaz University of Medical Sciences

Inclusion criteria: Diagnosis of plantar fasciitis presenting with localized pain in the sole of the foot—particularly morning pain—persisting for at least one month. Exclusion criteria: Inflammatory diseases such as rheumatoid arthritis; history of direct trauma (with or without fracture of the foot bones); pregnancy; and a history of injections into the plantar fascia or incomplete courses of shockwave therapy or acupuncture within the preceding two months.

One group will undergo shockwave therapy, while the other will receive a combination treatment of shockwave therapy and acupuncture.

Age Gender BMI Occupation Comorbidity Treatment type Pain Disability

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.

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.