Comparison of the effectiveness of dry needling and extracorporeal shockwave therapy (ESWT) of calf muscles (gastrosoleus) in the treatment of patients with plantar fasciitis

The aim of this study was to compare the effectiveness of two treatment methods, dry needling and extracorporeal shockwave therapy (ESWT), on trigger points of the calf muscle in treating patients with plantar fasciitis.

A two-group, single-blind, randomized, parallel-group clinical trial on 44 patients. Block randomization was used for randomization.

The study site is the Department of Physical Medicine and Rehabilitation of Firoozgar Hospital in Tehran. Among the patients complaining of foot pain, 44 patients with a clinical diagnosis of plantar fasciitis and calf muscle trigger points who meet the inclusion criteria will be enrolled in the study after obtaining written consent and randomly divided into two groups. Blinding is single-blind in which the assessor and data analyst are blinded.

Inclusion criteria: Patients with a clinical diagnosis of plantar fasciitis with trigger points in the cuff muscles, symptoms for at least 6 weeks, and a commitment to not taking anti-inflammatory medications. Exclusion criteria: History of inflammatory diseases, use of anticoagulant medications, contraindications to ESWT and dry needling (pregnancy, bleeding disorders).

The first group will receive extracorporeal shockwave therapy (ESWT) of the plantar fascia and trigger points of the calf muscles, and the second group will receive ESWT of the plantar fascia and dry needling of the trigger points of the calf muscles. Both groups will be taught a home exercise program and ice massage.

Patient pain intensity with Visual Analog Scale, ankle function with Foot Function Index questionnaire, response to treatment with Roles and Maudsley Scale

This study uses a block randomization method, as follows: To ensure a balanced number of subjects in each group, blocks of equal size will be used. Given the sample size of 44 subjects, 11 blocks of 4 subjects will be designed, with each block containing two subjects in the ESWT group and two subjects in the dry-needling group. The order of assignment of subjects in each block is determined randomly using random number generation software. These combinations are written on identical pieces of paper, and each piece of paper is placed in an opaque envelope. The envelopes are organized in blocks and the patient is asked to select one envelope at random when he or she visits. The number inside the envelope determines the patient's treatment group, and this information is recorded on special forms. 1- Preparation of the randomization list: A random list containing different combinations of groups in each block (such as 1-2-1-2) is generated using the random number generation section of SPSS software. This list is given to the principal investigator and is used to assign patients to groups. 2- Preparation of envelopes: Same-sized pieces of paper are prepared and the numbers *1* for ESWT and *2* for dry needling are written on them. Each block will contain a combination of numbers according to the randomly generated list. The papers are placed separately inside opaque envelopes of the same size and shape. The papers are numbered sequentially and placed neatly in the blocks. 3- Allocation of patients to groups: The participant, upon visiting the clinic, randomly selects an envelope from the relevant block. After selecting the envelope, the number inside it indicates the treatment group to which the patient is assigned (1 or 2). The researcher records the allocation code and the remaining envelopes in the block are stored until the block is used up. In order to conceal allocation, the treatment group should not be known to the patient or the researcher until the moment each patient enters the study. This prevents bias.

In this study, due to the nature of the interventions, patients and therapists are aware of the type of treatment or intervention given to the patient, but the evaluator, who is responsible for collecting and analyzing the data, remains unaware of this information. • This is done as follows: 1- Use of coding: Treatment groups are identified without mentioning the intervention by labeling them as neutral codes (i.e., Group 1 and Group 2), and the evaluation team works only with these codes. The researcher will unassign the groups after conducting statistical analyses. 2- Separation of duties: Assessment and treatment are carried out by different individuals so that the evaluator has no direct interaction with the therapist.

All data is potentially shareable after de-identifying individual ID data

The access period starts 6 months after the results are published

It will be available only to researchers working in academic and scientific institutions

If needed, for use in future researches, please send a written request via email

Main researcher: Dr. Bijan Forough Email: forogh.b@iums.ac.ir

After sending the request to the e-mail, the information will be accessible within a period of about one week