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IRCT20210205050256N2 IRCT 2021-09-03 University of Lahore Effects of Transcutaneous Electrical Nerve Stimulation with Home-Based Program in Postpartum Patients with Low Back Pain Comparison of the effectiveness of Transcutaneous Electrical Nerve Stimulation along with Home Based Care Program in Postpartum Patients with Low Back Pain for Improving Pain, Disability and Quality of Life 2021-08-01 anticipated 100 Complete https://irct.ir/trial/58442 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In each group, 70 patients will be randomly distributed to two groups with the use of the lottery method of randomization. Slips will be prepared from 1 to 70. They will be homogeneous in shape, color, and size etc. Furthermore, they will be shuffled and will be placed in a box. The selected 35 slips will be allocated to Group 1, who will receive TENS plus supervised conventional home physical therapy program and the other 35 will be allocated to Group 2, who will receive conventional home physical therapy program, Blinding description: Outcome assessor blinding: Every patient will be assessed by an independent assessor at the start and end of total treatment sessions to keep the assessment unbiased. N/A Low Back Pain. Intervention 1: Intervention group 1: The patients in this group will receive TENS and conventional physical therapy along with home-based exercises. The electrodes of the TENS will be placed below shoulder blade level (T8), T10, L1, and sacral dimple level (S3). In conventional treatment, it will be hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions. Intervention 2: Intervention group 2: The patients in this group will receive only conventional physical therapy along with home-based exercises. In conventional treatment, it will be a hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions. 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 Dr. Bilal Umar
1 km Defence Road, Bhobatian Chowk. Lahore
Lahore Pakistan 54000 +92 42 32300865 info@uol.edu.pk University of Lahore scientific Dr. Bilal Umar
1 km Defence Road, Bhobatian Chowk. Lahore
Lahore Pakistan 54000 +92 42 32300865 info@uol.edu.pk University of Lahore Pakistan Age range between 18 to 40 years Female who have normal delivery Female with six week post-partum Female having low back pain 18 years 40 years Female Anatomical anomaly Structural disorder of spinal alignment (Scoliosis, kyphosis, lordosis) Traumatic / Inflammatory / Infectious Conditions Diagnosed stress / depression / Anxiety M54.5 Low Back Pain Treatment - Devices Treatment - Other Intervention group 1: The patients in this group will receive TENS and conventional physical therapy along with home-based exercises. The electrodes of the TENS will be placed below shoulder blade level (T8), T10, L1, and sacral dimple level (S3). In conventional treatment, it will be hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions. Intervention group 2: The patients in this group will receive only conventional physical therapy along with home-based exercises. In conventional treatment, it will be a hot pack and lumbar isometrics. Home-based exercises will include bridging, ankle pumps and straight leg raises with 1 set and 10 repetitions. Pain. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Numeric Pain Rating Scale (NPRS). Disability. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Modified Oswestry Disability Index (MODI). Quality of Life. Timepoint: Before intervention and 4 weeks after intervention. Method of measurement: Short-Form 36. University of Lahore Approved 2020-03-04 Institutional Review Board 1 km Defence Road, Bhobatian Chowk. Lahore Lahore Punjab Pakistan