]>
IRCT20230225057527N1 IRCT 2023-03-14 Tehran University of Medical Sciences Comparison of Effects of Extra Shock Wave Therapy and Percussion Massagegun Comparison Study of Effects of Extra Corporeal Shock Wave Therapy and Percussion Massagegun on Pain, Spasm and Performance in Amateur Athletes with subacute Myofascial Pain in Gasterocenemious Muscle 2023-04-21 anticipated 42 Complete https://irct.ir/trial/68844 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Factorial, Purpose: Treatment, Randomization description: To randomize the interventions, three sealed envelopes containing the name of the group are provided to each individual, and without knowing the contents of the envelopes, and the subjects are randomly assigned to one of the treatment groups (massagegun, shock wave, and control) by taking one envelope without knowing its content. Then, the second researcher starts the therapeutic intervention, Blinding description: As for blinding, two researchers participate in this study, among whom the first is responsible for the initial and final evaluation of the patients, and another treats the patients without knowing the results of the evaluations. N/A Myofascial pain syndrome. Intervention 1: Intervention group I: Shock wave with 2500-3000 impulses in the most painful site of muscle and painful, as well as radial shock with 20 Hz and 300 impulses in the surrounding tissue; electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of shock wave treatment in home. Intervention 2: Control group: electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of treatment in home. Intervention 3: Intervention group II: Sweep massage of the whole muscle bulk for five minutes at a moderate rate (2400-2700 Hz or level 5 & 6) and direct massage in the most painful site of muscle and painful trigger point for three minutes; electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of treatment in home. Yes - There is a plan to make this available What will be shared: In this study, the data related to primary and secondary outcomes are comparatively shared in tables. When: The outcomes are accessible three months after publishing the article. To whom: Researchers working with the orthopedic and sports injuries of ordinary individuals and athletes at different levels in academic, sports medicine, and sports physiotherapy centers. Conditions: The data are allowed to be used in the studies on percussion massage gun, shock wave, and myofascial pain syndrome assessment, as well as evaluating and preparing an optimal treatment protocol for soft tissue and muscle disorders. Where to obtain: The applicants can correspond with Miss Seyedeh Zohreh Hosseini, the data manager, via email and request the desired data. zshosseini1998@gmail.com How to obtain: To access the study data, applicants should send their request containing the need to the data, reason for the request, and information indicating their affiliation to a university or a related research medical center, as well as the generalities of their research. Then, the data manager sends the intended data after assessing the person's information and its accuracy. Comments:
public Seyedeh zohreh Hosseini
No. 17, Alley 10, Tohid Blvd., Qom City
Qom Iran (Islamic Republic of) 3713898565 +98 25 3882 0138 zshosseini1998@gmail.com Tehran University of Medical Sciences scientific Siamak Bashardoust Tajali
Physical Therapy Department,. Rehabilitation school of Tehran University of Medical Sciences,. Pich Shemiran,. Enqelab St., Between Sadi St. & Darvazeh Shemiran, Tehran City
Tehran Iran (Islamic Republic of) 11489-65111 +98 21 7752 8468 s_bashardoust@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Amateur athletes aged 18-30 years with a BMI of 18-25. Pain in the posterior leg muscles (VAS: 3-7) during single-leg movements, affecting the person for at least two weeks. Local pain and tenderness in one or more points, or gastrocnemius muscle bundles in one leg, as well as at least one of the referred pain symptoms related to the TP or muscle bundle (e.g., muscle pain, tingling, and numbness) in the posterior leg muscles, or posterior medial part of ankle, toes, or behind the knee and thigh during rest or active ankle movement, which have limited the person for at least two weeks. Loss of ROM with pain and tissue tension in dorsiflexion movement. No history of systemic disease, especially hypertension, severe liver disease, renal dysfunction, or coagulopathy. No history of the neurological disease of the central nervous system (e.g., spondylolysis, spondylolisthesis ,and spinal canal stenosis, and epilepsy). No history of fracture or dislocation in the fibula and tibia bones during the last three months. No history of FX or dislocation in the ankle bones during the last three months. No history of tendinitis or Achilles tendon rupture during the last three months. Patients are physically examined, among whom those with symptoms such as swelling and blackening of the skin, as well as the swelling, stiffness, and pain in the involved vessels were excluded from the study as a case suspected of venous thrombosis. To enter the study, candidates must be devoid of any suspected symptoms of compartment syndrome, including general hardness in the entire involved muscle compartment, decreased pulse at the treatment site and its end, muscle herniation, and walking pattern with ankle pronation. Any extensive and painful echymosis and bruises in the cuff muscle along with a history of severe and sudden trauma or activities (were excluded and subjected a more detailed examination of soft tissue injuries in the area such as cuff contusion and strain of the gastrocnemius and soleus muscles). Patients should have no experience of strong sudden impact or movement along with sudden sharp pain and popping sound in the leg area in the last 3 months. No inflammation or redness or swelling on the site. Lack of wound or skin problems in the treatment site. Lack of active bleeding in the treatment site. Lack of infection in the treatment site. 18 years 30 years Both Unwillingness to continue the cooperation. Receiving drug or physical intervention at the same time as the treatment period. The patients with MPS who have neurological or atherogenic symptoms such as the symptoms of spinal canal stenosis, and rupture or chronic tendinitis of the Achilles tendon during treatment. Occurring Contraindications to massage (edema, wound, active bleeding, and infection) or contraindications to the use of shock wave (hypertension, wound, new bleeding, skin problems, severe liver disease, epilepsy, renal dysfunction, or coagulopathy) during the study. Any feeling of intense heat in the desired tissue, change in tissue color to dark colors along with increased pain, and any symptoms suggesting the possibility of deep vessel involvement is immediately recorded. The patient is excluded from the routine treatment process and evaluated with the necessary tests. Regarding the patient feeling significant stiffness and hardness in the gastrocnemius muscles along with paresthesia, decreased pulse in the end part of the limb, and other symptoms suggesting the possibility of compartment syndrome during the treatment sessions, the routine treatment is stopped, and the patient is excluded from the study process and subjected to emergency treatment. Rehabilitation Rehabilitation Rehabilitation Intervention group I: Shock wave with 2500-3000 impulses in the most painful site of muscle and painful, as well as radial shock with 20 Hz and 300 impulses in the surrounding tissue; electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of shock wave treatment in home Control group: electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of treatment in home Intervention group II: Sweep massage of the whole muscle bulk for five minutes at a moderate rate (2400-2700 Hz or level 5 & 6) and direct massage in the most painful site of muscle and painful trigger point for three minutes; electrotherapy involving 15 minutes of transcutaneous electrical stimulation (TENS) (100Hz and 0.2 ms width pulse) and standing gasterocnemius stretching with dorsi flexion for one set with 15s hold and eight repetitions, followed by two sets of muscle stretching with 15 s hold and eight repetitions after ending the sessions of treatment in home Pain. Timepoint: Pre-intervention and 3 days post-intervention. Method of measurement: Visual analog scale and assessing point pressure threshold based on algometer. Ankle joint range of motion (dorsi flexion and plantar flexion). Timepoint: Pre-intervention and 3 days post-intervention. Method of measurement: Goniameter. Gastrocnemius muscle strength. Timepoint: Pre-intervention and 3 days post-intervention. Method of measurement: Recording maximum isometric force by using dynamometery in non weight bearing position and single leg plantar flexor rising test in standing position. General performance. Timepoint: Pre-intervention and 3 days post intervention. Method of measurement: Lower Extremity Functional Scale (LEFS). Sport performance (strength performance). Timepoint: Pre-intervention and 3 days after intervention. Method of measurement: Single leg triple hop test for distance and vertical jump test. Tehran University of Medical Sciences Approved 2023-02-23 Ethics Committee of Tehran University of Medical Sciences Secretariat of the Committee for Ethics in Biomedical Research of Tehran University of Medical Sciences, Sixth Floor, Central Building of Tehran University of Medical Sciences, West Corner of Ghods St., Keshavarz Blvd., Tehran City, Tehran Tehran Tehran Iran (Islamic Republic of)