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IRCT20241111063665N1 IRCT 2025-03-17 self Clinical Outcomes of Low Versus Versus High Intensity Laser Therapy in the Treatment of Patients with Subacute Carpal Tunnel Syndrome Clinical Outcomes of Low Versus Versus High Intensity Laser Therapy in the Treatment of Patients with Subacute Carpal Tunnel Syndrome 2024-08-29 anticipated 69 Complete https://irct.ir/trial/80174 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The study utilized block randomization to allocate participants into two groups. Individuals were the unit of randomization. To ensure balance between groups, blocks of size 4 or 6 were created, with a pre-determined sequence of assignments (e.g., AABB, ABBA). A computer-based randomization tool was used to generate the random sequence, ensuring unbiased group allocation. The sequence was concealed, meaning participants were assigned to the next available slot in the random sequence without prior knowledge of the upcoming assignments. This allocation concealment prevented bias in group assignment. However, since the sampling method was non-probability, generalizability may be limited. The randomization tool ensured that the process was reliable and transparent, Blinding description: The study used double blinding to reduce bias. Participants were unaware of their group assignments and the specifics of the treatment they received. Similarly, assessors evaluating the outcomes were also blinded to the group allocations. This ensured that neither the participants' responses nor the assessors' evaluations were influenced by knowledge of the treatment protocols. The double-blinding helped maintain the objectivity and integrity of the study. N/A Subacute Carpal Tunnel Syndrome. Intervention 1: Intervention group: A High-Intensity Laser Therapy + Physical Therapy Participants in Group A will receive High-Intensity Laser Therapy combined with Physical Therapy. The laser therapy will be delivered using a device emitting low fluency (1/6 W, 8 J/cm²). The therapy will be administered three times per week for 5 weeks. Alongside laser therapy, participants will perform four standard exercises: active and active-assisted wrist extension, active finger flexion and extension, and weight-bearing exercises on extended wrists. These treatments aim to assess the combined effects of high-intensity laser therapy and physical therapy on pain reduction and functional recovery. Intervention 2: Intervention group: B Low-intensity laser therapy group + Physical Therapy Group B will receive Low-Level Laser Therapy (LLLT) in combination with Physical Therapy. The LLLT will be delivered using high fluency (50 mW, 20 J/cm²), administered three times per week for 5 weeks. As with Group A, participants will perform the same four standard exercises, aimed at improving wrist and finger movements along with functional strength. This group will evaluate the impact of low-intensity laser therapy combined with physical therapy on recovery and pain management. Intervention 3: Intervention group: C Physical Therapy Group C will receive Physical Therapy only, with no laser therapy. The same four standard exercises (active wrist extension, active finger flexion/extension, and weight-bearing wrist exercises) will be provided. This group serves as a control to compare the effectiveness of physical therapy alone against the laser therapy groups. Participants will receive no laser treatment, allowing for assessment of the placebo effect of the laser therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is undecided
public Arif Ali Rana
665-F block Central Park Housing Society Ferozpur Road Lahore
Lahore Pakistan 54000 +92 42 34500003 Arifalirana@gmail.com University of Lahore scientific Arif Ali Rana
665-F block Central Park Housing Society Ferozpur Road Lahore
Lahore Pakistan 54000 +92 42 34500003 Arifalirana@gmail.com Central Park Medical College, Lahore Pakistan Age of participants 20-40 years Individuals who have been diagnosed with carpal tunnel syndrome, regardless of gender Based on electromyography-nerve conduction velocity (EMG-NCV) investigation, the diagnosis of mild carpal tunnel syndrome was confirmed. This involves the involvement of both sensory and motor fibers to the extent that none are absent, with a sensory and motor delay of more than 3.6 msec and 4.1 msec, respectively. 20 years 40 years Both According to an EMG-NCV investigation, there are patients with mild (sensory nerve latency >3.5 ms at third digit) and severe (missing sensory or motor waves) CTS. Patients with a history of continuous physical therapy or exercise during the previous two weeks, or taking analgesic or anti-inflammatory drugs during the week before the baseline assessment. Hypothyroidism Cancer Active infection Pulmonary disease Acquired immunodeficiency syndrome Associated Myopathy Myelopathy History of neck and/or shoulder surgery, drug abuse, corticosteroid consumption, and high-risk pregnancy G56.0 Carpal tunnel syndrome Treatment - Devices Treatment - Devices Rehabilitation Intervention group: A High-Intensity Laser Therapy + Physical Therapy Participants in Group A will receive High-Intensity Laser Therapy combined with Physical Therapy. The laser therapy will be delivered using a device emitting low fluency (1/6 W, 8 J/cm²). The therapy will be administered three times per week for 5 weeks. Alongside laser therapy, participants will perform four standard exercises: active and active-assisted wrist extension, active finger flexion and extension, and weight-bearing exercises on extended wrists. These treatments aim to assess the combined effects of high-intensity laser therapy and physical therapy on pain reduction and functional recovery. Intervention group: B Low-intensity laser therapy group + Physical Therapy Group B will receive Low-Level Laser Therapy (LLLT) in combination with Physical Therapy. The LLLT will be delivered using high fluency (50 mW, 20 J/cm²), administered three times per week for 5 weeks. As with Group A, participants will perform the same four standard exercises, aimed at improving wrist and finger movements along with functional strength. This group will evaluate the impact of low-intensity laser therapy combined with physical therapy on recovery and pain management. Intervention group: C Physical Therapy Group C will receive Physical Therapy only, with no laser therapy. The same four standard exercises (active wrist extension, active finger flexion/extension, and weight-bearing wrist exercises) will be provided. This group serves as a control to compare the effectiveness of physical therapy alone against the laser therapy groups. Participants will receive no laser treatment, allowing for assessment of the placebo effect of the laser therapy Ultrasound changes. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Ultrasound. CMAP and SNAP latencies. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Nerve Conduction Studies. Pain. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Visual Analogue Scale. Electrophysiological Changes. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Nerve Conduction Studies and EMG. Hand Grip/ Strength. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Handheld Dynamometer. Quality of Life. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: Quality of Life Scale. Hand Function. Timepoint: Before intervention and after 5 weeks of Intervention. Method of measurement: SF-36. Self Approved 2024-08-22 Research Ethics Committee (REC-Phd) FAHS, University of Lahore 6-km Defence Road Bhobatian Chawk Lahore Lahore Punjab Pakistan