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IRCT20190306042945N6 IRCT 2025-06-04 Iran University of Medical Sciences Studying the effect of dry needling and shockwave therapy on calf muscles in the treatment of plantar fasciitis Comparison of the effectiveness of dry needling and extracorporeal shockwave therapy (ESWT) of calf muscles (gastrosoleus) in the treatment of patients with plantar fasciitis 2025-06-15 anticipated 44 Recruiting https://irct.ir/trial/83325 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 3 Plantar fasciitis. Intervention 1: Intervention group 1: Patients will be treated with ESWT of the plantar fascia and the trigger points of the cuff muscles. ESWT treatment will be performed using a STORZ Medical MASTERPULS MP100 device with a protocol of 3000 shock waves per session / Energy Flux Density 0.2 mJ/mm² (average energy flux density: 0.10–0.20 mJ/mm²) / Frequency 8-10 Hz / Intensity 1.3 times based on patient tolerance (adjustable between 1.5 and 2.5 times) for the heel region and for the trigger points of the cuff muscles, 300 shock waves per session for each trigger point / Energy Flux Density 0.2 mJ/mm² / Frequency 8-10 Hz / Intensity up to 2.5 times based on patient tolerance. The treatment sessions of the patients will be arranged and performed in 3 sessions at one-week intervals. In addition, a shared treatment program is taught, including home exercises for stretching the plantar fascia and calf muscles, and the use of cold in the form of ice massage. Intervention 2: Intervention group 2: Patients undergoing ESWT of the plantar fascia and dry needling of the calf muscles will receive trigger points. Treatment will be performed using dry needling (DN) with acupuncture needles measuring 50 x 0.6 mm on the trigger points in the gastrosoleus muscles. The physical therapist will manually examine the muscles for the presence of active or latent trigger points. Referred pain after squeezing taut bands/trigger points is considered active trigger points. Local pain after palpation of the trigger points is assessed as latent trigger points. Dry needling is applied based on the location of myofascial trigger points in the gastrosoleus muscles, as defined by Simons et al. The patient will be in the prone position during treatment. The needle will be adjusted with processing or withdrawal movements until a local twitch response is obtained. If the patient feels severe discomfort, the treatment will be performed intermittently. ESWT treatment of the heel region is performed by the STORZ Medical MASTERPULS MP100 device with a protocol of 3000 shock waves per session / Energy Flux Density 0.2 mJ/mm² (average energy flux density: 0.10–0.20 mJ/mm²) / Frequency 8-10 Hz / Intensity 1.3 times based on patient tolerance (adjustable between 1.5 and 2.5 times). Patients' treatment sessions are arranged and performed in 3 sessions at one-week intervals. In addition, a joint treatment program is taught, including home exercises for stretching the plantar fascia and calf cuff muscles and the use of cold in the form of ice massage. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individual ID data When: The access period starts 6 months after the results are published To whom: It will be available only to researchers working in academic and scientific institutions Conditions: If needed, for use in future researches, please send a written request via email Where to obtain: Main researcher: Dr. Bijan Forough Email: forogh.b@iums.ac.ir How to obtain: After sending the request to the e-mail, the information will be accessible within a period of about one week Comments:
public Mohammad Rajabi
Firoozgar Hospital, Beh Afarin Street, Karim Khan Zand Street, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1612 Rajabi.m.1373@gmail.com Iran University of Medical Sciences scientific Bijan Forogh
Firoozgar Hospital, Beh Afarin Street, Karim Khan Zand Street, Valiasr Square, Tehran
Tehran Iran (Islamic Republic of) 1593747811 +98 21 8214 1612 forogh.b@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Pain severity: Baseline pain intensity ≥ 4 on a Visual Analog Scale (VAS) 0-10 Duration of symptoms: Presence of symptoms of plantar fasciitis for at least 6 weeks. Clinical diagnosis: Patients with plantar fasciitis and have tender points in the gastrocnemius-soleus muscles on the same side of the affected area, and this issue is clinically assessed and diagnosed by a physical medicine and rehabilitation specialist. No previous treatment or failure of conservative treatment: The patient must not have previously received any medical treatment for this disease or previous conservative treatments (NSAIDs or other analgesics, exercise programs and shoe inserts) have not been effective. Commitment to not taking anti-inflammatory drugs: Acceptance of not taking anti-inflammatory drugs during the treatment period. General health: No known acute or chronic inflammatory diseases or taking medications that interfere with the effects of treatment, including NSAIDs for other reasons Informed consent to participate in the study. Education level: Having sufficient education to understand the treatment methods and interventions performed and the ability to complete the assessment forms in this study 18 years 70 years Both Malignancy (cancer) Active infections History of systemic inflammatory diseases or disseminated inflammatory rheumatic diseases Trauma Open wounds or injuries in the legs Neuropathy (nerve disorders) Radiculopathy (pressure on the spinal nerves) Peripheral vascular disorders (circulation problems in the limbs) Coagulation disorders (blood clotting problems) Use of anticoagulant drugs (due to increased risk of bleeding) Arthropathy (joint disease) Congenital or acquired deformities in the lower extremities Sequelae of previous fractures in the lower extremities Presence of metal prostheses or implants (including screws, pacemakers or internal fixators) in the treatment area Inability to understand the treatment or cognitive impairment if the person is unable to understand the treatment or complete the relevant assessment forms Previous treatment history including ESWT, injections in the area (corticosteroids, Platelet-rich plasma (PRP), prolotherapy) Not willing to participate in the study Contraindications to ESWT and dry needling, such as metal allergies, pregnancy, bleeding disorders Severe mental disorder including conditions that may impair the ability to provide informed consent or adhere to treatment protocols M72.2 Plantar fascial fibromatosis Treatment - Devices Treatment - Devices Intervention group 1: Patients will be treated with ESWT of the plantar fascia and the trigger points of the cuff muscles. ESWT treatment will be performed using a STORZ Medical MASTERPULS MP100 device with a protocol of 3000 shock waves per session / Energy Flux Density 0.2 mJ/mm² (average energy flux density: 0.10–0.20 mJ/mm²) / Frequency 8-10 Hz / Intensity 1.3 times based on patient tolerance (adjustable between 1.5 and 2.5 times) for the heel region and for the trigger points of the cuff muscles, 300 shock waves per session for each trigger point / Energy Flux Density 0.2 mJ/mm² / Frequency 8-10 Hz / Intensity up to 2.5 times based on patient tolerance. The treatment sessions of the patients will be arranged and performed in 3 sessions at one-week intervals. In addition, a shared treatment program is taught, including home exercises for stretching the plantar fascia and calf muscles, and the use of cold in the form of ice massage. Intervention group 2: Patients undergoing ESWT of the plantar fascia and dry needling of the calf muscles will receive trigger points. Treatment will be performed using dry needling (DN) with acupuncture needles measuring 50 x 0.6 mm on the trigger points in the gastrosoleus muscles. The physical therapist will manually examine the muscles for the presence of active or latent trigger points. Referred pain after squeezing taut bands/trigger points is considered active trigger points. Local pain after palpation of the trigger points is assessed as latent trigger points. Dry needling is applied based on the location of myofascial trigger points in the gastrosoleus muscles, as defined by Simons et al. The patient will be in the prone position during treatment. The needle will be adjusted with processing or withdrawal movements until a local twitch response is obtained. If the patient feels severe discomfort, the treatment will be performed intermittently. ESWT treatment of the heel region is performed by the STORZ Medical MASTERPULS MP100 device with a protocol of 3000 shock waves per session / Energy Flux Density 0.2 mJ/mm² (average energy flux density: 0.10–0.20 mJ/mm²) / Frequency 8-10 Hz / Intensity 1.3 times based on patient tolerance (adjustable between 1.5 and 2.5 times). Patients' treatment sessions are arranged and performed in 3 sessions at one-week intervals. In addition, a joint treatment program is taught, including home exercises for stretching the plantar fascia and calf cuff muscles and the use of cold in the form of ice massage. Patient's pain intensity with Visual Analogue Scale. Timepoint: In 3 sessions, before the start of the intervention, one month and three months after completing the three intervention sessions. Method of measurement: Completion of the Visual Analogue Scale by the patient. Ankle function assessment based on Foot function index (FFI). Timepoint: In 3 sessions, before the start of the intervention, one month and three months after completing the three intervention sessions. Method of measurement: Completion of the Foot Function Index (FFI) questionnaire by the patient. Response to treatment and satisfaction with patient treatment based on the Roles and Maudsley Scale (RMS). Timepoint: In 3 sessions, before the start of the intervention, one month and three months after completing the three intervention sessions. Method of measurement: The patient describes their condition after treatment, and the doctor, based on these descriptions and clinical assessment, selects one of the four levels of the Roles and Maudsley Scale (RMS) and assigns the patient a score. Iran University of Medical Sciences Approved 2025-03-12 Ethics committee of Iran University of Medical Sciences Vice-Chancellor of Research and Technology , Central Headquarters Building, Iran University of Medical Sciences, next to Milad tower, Hemmat Highway Tehran Tehran Iran (Islamic Republic of)