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IRCT20200826048530N1 IRCT 2023-10-01 Sindh Institute of Physical Medicine and Rehabilitation DRY NEEDLING AND SPINAL MANIPULATIVE THERAPY VERSUS SPINAL MANIPULATIVE THERAPY ALONE IN NON-SPECIFIC CHRONIC LOW BACK PAIN COMPARISON OF DRY NEEDLING AND SPINAL MANIPULATIVE THERAPY VERSUS SPINAL MANIPULATIVE THERAPY ALONE ON PAIN AND DISABILITY IN PATIENTS WITH NON-SPECIFIC CHRONIC LOW BACK PAIN 2019-02-04 anticipated 128 Complete https://irct.ir/trial/61988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: The subjects are randomly assigned to one of two groups by using simple randomization method using computer-generated random numbers and the random sequence is built with the computer generated software. The unit of the randomization is individual patient. The allocation concealment is carried out, Blinding description: This study is a single blinded randomized controlled trial in which assessor (another PT) will not be aware of the treatment groups. The principal investigator has to perform all the treatment sessions so it would not be possible to be blinded. Also, the participant cannot be blinded because of the different nature of interventions. N/A Non-specific chronic low back pain. Intervention 1: Intervention group: Spinal manipulative therapy and dry needling (DN). Participants allocated to this group will recieve both Spinal manipulative therapy and dry needling. For the spinal manipulative therapy, patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis. The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings. After this the Active TrPs located in the gluteus medius and quadratus lumborum muscles will be treated with DN. These muscles will be chosen because active TrPs are prevalent in patients with chronic mechanical LBP. The disposable stainless steel needles (0.25 × 32 mm and0.25 × 32 mm) that will be inserted through the skin over the active TrP. In this study, the fast-in and fast-out technique described by Hong will be applied. After locating an active TrP, the overlying skin will be cleaned with alcohol, and the needle will be subsequently inserted, penetrating the skin and muscle till 16 to 20 mm into the TrP. The position of the patient will be side lying. Once inserted into the TrP, the needle will be moved in multiple directions until the first local twitch response is obtained. Once the first local twitch response willl be obtained, the needling will be performed in an up and down fashion, at approximately 1 Hz for 25 to 30 seconds with the aim of eliciting different local twitch responses. The interventions will be provided by a clinician with 10 years of experience. Total number of intervention session is 12 with intervention duration is set is 8 weeks, comprising of an hourly session with a frequency of two session per week for manipulative therapy including one day treatment of DN till 4th week and after that one session of manipulative therapy plus DN per week. Intervention 2: This group will recieve spinal manipulative therapy only. The patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis . The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings. No - There is not a plan to make this available Justification or reason for not sharing IPD is Results will be published by the investigators in academic journals. Sharing of generated study data will be carried out in several different ways. We plan to make our results available to researchers and potential collaborators interested in physical medicine rehabilitation and low back pain.
public Kashmala
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
Karachi Pakistan 74200 +92 21 99216213 kashmala_khan84@hotmail.com Sindh Institute of Physical Medicine and Rehabilitation scientific Kashmala
Chand Bibi Rd، near Mujahid Masjid, Deli Colony Ranchore Lane
Karachi Pakistan 74200 +92 21 99216213 kashmala_khan84@hotmail.com Sindh Institute of Physical Medicine and Rehabilitation Pakistan Patients willing to be part of the study Patients diagnosed as having chronic nonspecific low back pain Age 18 –60 years Both male and female History of non-specific LBP without referral into the lower extremity Score 4 points on the Roland Morris Disability Questionnaire Have not received physical therapy within the last 3 months Exhibit at least 1 active TrP reproducing their symptom in quadratus lumborum , gluteus medius and paraspinal muscle 18 years 60 years Both Any serious spinal pathology (e.g. inflammatory or infectious condition of the spinemetastatic fracture, cauda-equina syndrome etc) Compromised nerve root Any history of spinal surgery Any other conditions that would affect the active participation in the treatment. Long term steroid use Any neurological condition Osteoporosis M54.5 Low back pain Rehabilitation Rehabilitation Intervention group: Spinal manipulative therapy and dry needling (DN). Participants allocated to this group will recieve both Spinal manipulative therapy and dry needling. For the spinal manipulative therapy, patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis. The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings. After this the Active TrPs located in the gluteus medius and quadratus lumborum muscles will be treated with DN. These muscles will be chosen because active TrPs are prevalent in patients with chronic mechanical LBP. The disposable stainless steel needles (0.25 × 32 mm and0.25 × 32 mm) that will be inserted through the skin over the active TrP. In this study, the fast-in and fast-out technique described by Hong will be applied. After locating an active TrP, the overlying skin will be cleaned with alcohol, and the needle will be subsequently inserted, penetrating the skin and muscle till 16 to 20 mm into the TrP. The position of the patient will be side lying. Once inserted into the TrP, the needle will be moved in multiple directions until the first local twitch response is obtained. Once the first local twitch response willl be obtained, the needling will be performed in an up and down fashion, at approximately 1 Hz for 25 to 30 seconds with the aim of eliciting different local twitch responses. The interventions will be provided by a clinician with 10 years of experience. Total number of intervention session is 12 with intervention duration is set is 8 weeks, comprising of an hourly session with a frequency of two session per week for manipulative therapy including one day treatment of DN till 4th week and after that one session of manipulative therapy plus DN per week. This group will recieve spinal manipulative therapy only. The patient will be treated with joint mobilization or manipulation techniques applied to the spine or pelvis . The particular dose and techniques will be at the discretion of the treating physical therapist, based on each participant’s physical examination findings. Pian intensity. Timepoint: before intervent and 4, 8 weeks, 6 months after intervention. Method of measurement: Visual Analogue Scale (VAS-0 to 10cm) for pain intensity. increase in scores suggests increase in pain intensity and decrease suggests decrease in pain intensity. Range of motion of lumbar spine. Timepoint: before intervent and 4, 8 weeks, 6 months after intervention. Method of measurement: Modified-modified Schöber Test to measure flexion of lumbar spine. Disability. Timepoint: before intervent and 4, 8 weeks, 6 months after intervention. Method of measurement: Ronald Morris Disability Questionnaire (RMDQ) for disability. Lumbar muscle endurance. Timepoint: before intervent and 4, 8 weeks, 6 months after intervention. Method of measurement: Sorensen test for lumbar muscle endurance. context and facilities for the conduct of trial Approved 2019-01-07 Instituitional Review Board of the University of Lahore 1-Km Defence Road،, near Bhuptian Chowk، Lahore Punjab Pakistan