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IRCT20240125060803N1 IRCT 2024-06-01 The university of lahore Therapeutic Outcomes Of Dry Needling Coupled With Intramuscular Stimulation In Patients With Fibromyalgia Syndrome RCT Therapeutic Outcomes Of Dry Needling Coupled With Intramuscular Stimulation In Patients With Fibromyalgia Syndrome 2024-06-10 anticipated 78 Complete https://irct.ir/trial/76607 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Computerized method of randomization will be used to randomized screened eligible patients to Group A and B. OxMaR will be used for this purpose, which is an open source free software for online minimization and randomization for clinical trials, Blinding description: It will be single blinded, only the assessor would be managed to be masked from treatment options and outcomes. Ultimately, the decision about which type of blinding to use in a clinical trial will depend on the specific research question being addressed, the nature of the treatments being compared, and the resources and logistics of the study. N/A Fibromyalgia Syndrome. Intervention 1: Intervention group: Dry Needling With Intramuscular Electrical Stimulation. Intervention 2: Control group: Dry Needling Group. 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 There is no further information
public Muhammad Asim Arif
1-km defence road, off bhoptian chowk, raiwind road, Lahore
Lahore Pakistan 54000 +92 321 6597727 asim.arif@uipt.uol.edu.pk The University of Lahore scientific Muhammad Asim Arif
1-km defence road, off bhoptian chowk, raiwind road, Lahore
Lahore Pakistan 54000 +92 321 6597727 asim.arif@uipt.uol.edu.pk The University of Lahore Pakistan Both male and female patients Age over 18 years and under 60 years Pre diagnosed patients with FMS referred through consultant Manifesting chronic widespread musculoskeletal pain symptoms Presence of active trigger points, as confirmed by physical examination Willing and able to provide informed consent to participate in the study. Ability to understand and comply with the study requirements No contraindications to dry needling or IMS 18 years 60 years Both Pregnancy or breastfeeding Use of any medications that could interfere with the study results (e.g. muscle relaxants, opioids) within the past 48 hours. Previous treatment with dry needling or IMS within the past 6 months Presence of any other conditions that could interfere with the study results (e.g. cancer, infection) Participation in any other clinical trials within the past 30 days Anatomical anomaly Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis)o Any bone abnormality in neck region Traumatic/ Inflammatory/ Infectious Conditions such as Recent Trauma, Nerve root compromise, Metabolic or serious spinal pathologies (e.g., fractures, tumors, inflammatory, and infectious diseases), Previous neck surgery Psycho-social Instability such as Diagnosed stress/ depression/ Anxiety Risk Profile such as High Risk Inability to understand or comply with the study requirements, as determined by the physiotherapist M79.7 Fibromyalgia Treatment - Other Treatment - Other Intervention group: Dry Needling With Intramuscular Electrical Stimulation Control group: Dry Needling Group Pain. Timepoint: Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval. Method of measurement: Numeric Pain Rating Scale. Pressure. Timepoint: Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval. Method of measurement: Pain pressure threshold; algometer. Anxiety depression. Timepoint: Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval. Method of measurement: Hospital Anxiety and Depression Scale (HADS). Quality of Sleep. Timepoint: Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval. Method of measurement: Pittsburgh Sleep Quality Index (PSQI). Fatigue. Timepoint: Baseline screening, Assessment at 2nd week interval, Assessment at 4th week interval, Follow up at 8th week interval. Method of measurement: Multidimensional Fatigue Inventory (MFI). The university of lahore Approved 2024-05-22 Research ethical committee 1-Km Defence Road, Off Bhoptian Chowk, Raiwind Road, Lahore lahore punjab Pakistan