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IRCT20221030056342N3 IRCT 2024-10-24 Mashhad University of Medical Sciences The effect of physical therapy combined with dry needling compared to physical therapy alone on hand muscle strength in people with carpal tunnel syndrome Investigating the effect of physical therapy combined with dry needling compared to physical therapy alone on hand muscle strength in people with carpal tunnel syndrome: a randomized clinical trial 2024-12-02 anticipated 34 Complete https://irct.ir/trial/79296 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In the present study, the quadruple randomization block method will be used for randomization. For this method, the volume of each block must be determined first (for example, a quadruple block). Then write the list of blocks and assign numbers to them (AABB(1)- ABAB(2)-ABBA(3)-BBAA(4)- BABA(5)- BAAB(6)) then choose random numbers between 1 and 6 (for example, 1, 4, 5, etc.) and finally specifying the treatment allocation list based on the previous random numbers (...AABB-BBAA-BABA-).}. The website www.sealedenvelope.com will be used to generate the assigned sequences, Blinding description: Patients are randomly assigned to two groups of physical therapy alone (control group) and physical therapy with dry needling (treatment group) by the method of quadruple random blocks by a person who is not involved in any of the intervention and evaluation stages. N/A Carpal tunnel syndrome. Intervention 1: Intervention group: In the treatment group, in addition to the standard rehabilitation program that is also performed in the control group, dry needling will be applied in the wrist region based on the Four Pole Carpal Dry Needling technique by the physiotherapist. In this method, needles with dimensions of 25*0.30 mm are placed in their position in all patients according to anatomical references. The highest needles are at the scaphoid (proximal-radial: P-R) and pisiform (proximal-ulnar: P-U) bones, while the lowest ones are at the level of the trapezium (distal-radial: D-R) and hamate (distal-ulnar: D-U) bones. ) are placed. 4 oblique directional needles (45 degrees in both cranio-caudal and internal-external directions), slightly inclined to the back and at the same time follow the midline. Each needle is inserted into the tissue until an elastic state is felt, which in the absence of ultrasound confirmation is attributed to the transverse carpal ligament. Fascial winding technique (FWT) is then applied to each needle, which involves twisting them in one direction until reaching the final threshold of "Needle grasp". The rotation of the needles is limited due to their adhesion to the tissue, which means that by applying force to remove the needles, the tissue will be exposed to tension. This force is along the longitudinal axis of the needles, but it is not enough to pull them out of the tissue and it must be done simultaneously on each pair of opposite needles that are two by two miles together (i.e. P-R with D-U and P-U with D-R). At this moment, we consider the FWT complete. This method leads to continuous tension on the transverse carpal ligament, which is stronger and more effective. In the treatment group, dry needling will be performed at the beginning of the first, fifth and ninth sessions before routine physiotherapy, and patients will be advised to refrain from taking NSAIDs 24 hours before and after the dry needling treatment. Intervention 2: Control group: In the control group, the standard rehabilitation program includes electrotherapy, ultrasound modality, median nerve mobilization techniques and gliding flexor tendons, and exercises that will be placed in the form of brochures to be performed at the patient's home. The mobilization technique of the median nerve, which is performed by the physiotherapist, and the gliding of the flexor tendons will be explained in detail, and the patient will be taught how to do the exercise at home. The treatment duration of the standard rehabilitation program is 45 to 60 minutes per session. And it is as follows: 20 minutes of electrotherapy in the form of tennis with a frequency of 80 Hz and a pulse width of 60 microseconds - 5 minutes of interrupted ultrasound on the carpal tunnel area of ​​the wrist with a frequency of 1 MHz and an intensity of 1 watt per square centimeter - mobilization of the median nerve in 3 sets with 15 repetitions in Each session - Glide the flexor tendons of the hand so that each exercise is repeated 1 to 3 times for 10 times and each position is maintained for 5 seconds. Teaching exercises to stretch the transverse carpal ligament and glide the median nerve and flexor tendons to be done at home as follows: 1) Stretching the transverse carpal ligament by the patient: the patient is asked to bend his wrist upwards at a 90 degree angle. and connect his palm to the opposite wall, and with his opposite hand, slowly pull the thenar ridge towards him so that the transverse carpal ligament is stretched. Participants are asked to hold each stretch for 30 seconds and do it 4 times a day during their treatment period. Participants in this study will be treated for 12 sessions, 3 sessions per week. Yes - There is a plan to make this available What will be shared: All data will be reported in the form of a research article. Raw data will be delivered to researchers for meta analysis. When: 6 months after publication To whom: For researchers only Conditions: For meta-analysis Only Where to obtain: zeinalzadehAF@mums.ac.ir How to obtain: The response will be sent 3 within months after considering the researcher's request. Comments:
public Shayeste Jan Alizadeh
Faculty of Paramedical and Rehabilitation Sciences, Kharazmi Building, University Campus, East Door of Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 Janalizadehs4002@mums.ac.ir Mashhad University of Medical Sciences scientific Afsaneh Zeinalzadeh
Faculty of Paramedical and Rehabilitation Sciences, Kharazmi Building, University Campus, East Door of Mashhad University of Medical Sciences, Azadi Square
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 zeinalzadehAF@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Clinical diagnosis of CTS based on at least two criteria proposed by Chang Presence of symptoms for at least 4 weeks Confirmation of mild to moderate severity of CTS based on electrodiagnostic findings 20 years 65 years Both Clinical conditions that can mimic CTS include cervical radiculopathy, brachial plexus injury, proximal median neuropathy, or significant polyneuropathy. Severe CTS with visible muscle atrophy Diabetes Rheumatoid arthritis Hypothyroidism and hyperthyroidism Pregnancy and breastfeeding Alcohol abuse Taking medicine Malignancy G56.0 Carpal tunnel syndrome Rehabilitation Rehabilitation Intervention group: In the treatment group, in addition to the standard rehabilitation program that is also performed in the control group, dry needling will be applied in the wrist region based on the Four Pole Carpal Dry Needling technique by the physiotherapist. In this method, needles with dimensions of 25*0.30 mm are placed in their position in all patients according to anatomical references. The highest needles are at the scaphoid (proximal-radial: P-R) and pisiform (proximal-ulnar: P-U) bones, while the lowest ones are at the level of the trapezium (distal-radial: D-R) and hamate (distal-ulnar: D-U) bones. ) are placed. 4 oblique directional needles (45 degrees in both cranio-caudal and internal-external directions), slightly inclined to the back and at the same time follow the midline. Each needle is inserted into the tissue until an elastic state is felt, which in the absence of ultrasound confirmation is attributed to the transverse carpal ligament. Fascial winding technique (FWT) is then applied to each needle, which involves twisting them in one direction until reaching the final threshold of "Needle grasp". The rotation of the needles is limited due to their adhesion to the tissue, which means that by applying force to remove the needles, the tissue will be exposed to tension. This force is along the longitudinal axis of the needles, but it is not enough to pull them out of the tissue and it must be done simultaneously on each pair of opposite needles that are two by two miles together (i.e. P-R with D-U and P-U with D-R). At this moment, we consider the FWT complete. This method leads to continuous tension on the transverse carpal ligament, which is stronger and more effective. In the treatment group, dry needling will be performed at the beginning of the first, fifth and ninth sessions before routine physiotherapy, and patients will be advised to refrain from taking NSAIDs 24 hours before and after the dry needling treatment. Control group: In the control group, the standard rehabilitation program includes electrotherapy, ultrasound modality, median nerve mobilization techniques and gliding flexor tendons, and exercises that will be placed in the form of brochures to be performed at the patient's home. The mobilization technique of the median nerve, which is performed by the physiotherapist, and the gliding of the flexor tendons will be explained in detail, and the patient will be taught how to do the exercise at home. The treatment duration of the standard rehabilitation program is 45 to 60 minutes per session. And it is as follows: 20 minutes of electrotherapy in the form of tennis with a frequency of 80 Hz and a pulse width of 60 microseconds - 5 minutes of interrupted ultrasound on the carpal tunnel area of ​​the wrist with a frequency of 1 MHz and an intensity of 1 watt per square centimeter - mobilization of the median nerve in 3 sets with 15 repetitions in Each session - Glide the flexor tendons of the hand so that each exercise is repeated 1 to 3 times for 10 times and each position is maintained for 5 seconds. Teaching exercises to stretch the transverse carpal ligament and glide the median nerve and flexor tendons to be done at home as follows: 1) Stretching the transverse carpal ligament by the patient: the patient is asked to bend his wrist upwards at a 90 degree angle. and connect his palm to the opposite wall, and with his opposite hand, slowly pull the thenar ridge towards him so that the transverse carpal ligament is stretched. Participants are asked to hold each stretch for 30 seconds and do it 4 times a day during their treatment period. Participants in this study will be treated for 12 sessions, 3 sessions per week. Hand grip. Timepoint: Before, immediately after and six weeks after the end of treatment. Method of measurement: Grip strength will be measured in kilograms using a hand-held dynamometer. First, patients are taught how to work with the device. They are then asked to maintain maximum grip strength and press the handle 3 times with 10 seconds of rest between each test, and the average score of the three presses of the machine will be calculated. Pain severity. Timepoint: Before, immediately after and six weeks after completion. Method of measurement: Visual analog scale (VAS) will be used to evaluate pain intensity at rest (8). VAS is a 10-point scale from 0 to 10, where 0 represents "no pain" and 10 represents "worst possible pain". All participants are instructed to rate pain intensity based on the past 7 days. Functional status and symptom severity. Timepoint: Before, immediately after and six weeks after completion. Method of measurement: Functional status and severity of self-reported symptoms will be measured using the self-reported Boston Carpal Tunnel Questionnaire (BCTQ). This is a CTS-specific questionnaire that refers to a typical 24-hour period in the past two weeks. It consists of two different scales: Symptom Severity Scale (SSS) and Functional Status Scale (FSS). The SSS consists of 11 questions about symptom severity, while the FSS consists of 8 daily activities that are rated by severity. These two scales will be rated on a 5-point scale, where greater impairment is indicated by higher scores, and finally, the average of each section is calculated, and the higher the average, the greater the severity of the patient's symptoms and disability. The BCTQ is responsive to clinically relevant changes and is therefore an appropriate measure of treatment outcome. This questionnaire was Persianized by Mashhad University of Medical Sciences and its reliability and validity have been reported before. The effectiveness of treatment. Timepoint: Before, immediately after and six weeks after completion. Method of measurement: Global rating of change (GRC) will be used to evaluate the effectiveness of the treatment, which evaluates the patient's current health status compared to the patient's status at the beginning of the treatment. It is an 11-point Likert scale ranging from +5 (much better) to -5 (much worse). Mashhad University of Medical Sciences Approved 2024-02-24 Ethics Committee of Mashhad University of Medical Sciences Central Organization of Mashhad University of Medical Sciences, Knowledge and Health City, End of Shahid Fakuri Blvd. Mashhad Razavi Khorasan Iran (Islamic Republic of)