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IRCT20240923063127N1 IRCT 2024-11-22 University of Lahore Role of Total Motion Release in Patients with Lumbar Radiculopathy Role of Total Motion Release in Patients with Lumbar Radiculopathy 2024-03-05 anticipated 68 Complete https://irct.ir/trial/79628 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Individual simple randomization will be performed by one research team member who is blinded to the study and not involved in patient recruitment. The randomization process will utilize sealed, opaque envelopes to ensure allocation concealment. The random sequence will be generated using a random number table or computer software to avoid bias. This approach ensures proper probability-based allocation and maintains the integrity of the randomization process, Blinding description: This is a single blinded study in which outcome assessor will be blinded to group allocation. 2-3 A disorder known as lumbar radiculopathy, which is characterized by irritation or compression of the nerve roots in the lumbar spine, frequently causes severe pain, functional restrictions, and a decline in quality of life.. Intervention 1: Intervention group: The participants randomly will be allocated in Group A received the Total motion release. After 15 minutes of heat therapy along with TENS, neural mobilization exercises, consisting of both sliders and tensioners, will be provided. The patient will be positioned in high sitting, with the hands clasped behind and in slouched posture as base position. They will be performed neck extension and knee extension for the sliding technique, and neck flexion with knee extension for the tensioning technique . The movement range will be determined by the severity of symptoms and patient tolerance. The nerve sliding technique will be applied for 20-30 repetitions in 2-3 sets per day, and the nerve tensioning technique will be implemented in addition for 15-25 seconds in 5-7 repetitions. In total motion release treatment is given to unaffected side thus relieving symptoms of affected side with 5 reps & 10 times. It is very simple technique in which patient is made to perform five motion they are (Naik et al., 2019): 1) Arm raise 2) Trunk twist 3) Leg raise 4) Sit to stand and 5) Toe reach. Intervention 2: Intervention group: In Group B all allocated participants will be received conventional therapy. Conventional therapy includes 15 minutes of heat therapy along with TENS. Hot packs will be used to deliver superficial heating. Each treatment session will be lasted 30-45 minutes. TENS (Transcutaneous Electrical Nerve Stimulation) sessions will be lasted 15 min. The TENS will be applied in a conventional mode for 15 min at a high frequency of 70 Hz and wavelength of 100 microseconds by placing two 40 × 40 mm electrode sets cross arranged on each side of the lumbosacral spine.The intensity of the current will be increased to the point of observation of no contractions, but with a light tingling sensation, while ensuring the patient will be comfortable. Then mild stretches of hamstrings and piriformis muscle, core stabilization exercises and sciatic nerve mobilization will be done. Yes - There is a plan to make this available What will be shared: Demographic data and data related to final outcome will be shared by maintaining the confidentially When: Data will be available after the publication of findings till six months To whom: De-identified individual participant data (IPD) and supporting documents will be shared for research purposes only and will be available up to six months after the publication of findings. Access is primarily for individuals working in academic institutions; however, those from other organizations, such as businesses, may also apply with a valid research proposal. Requests can be directed to the corresponding author, Ayesha Maroof, at ayeshaa.khan1512@gmail.com or +92 305 8803766. Additionally, data will be shared through public releases in accordance with established traditions for open access. Conditions: For research purpose Where to obtain: To the corresponding author of the study, Ayesha Maroof and can contact on +92 305 8803766 , Ayeshaa.khan1512@gmail.com How to obtain: Open access and there is the traditional public data releases where anyone can get access to the data Comments:
public Ayesha Maroof
1-km Defence Road , near Bhuptian Chowk,Lahore , Punjab
Lahore Pakistan 55150 +92 305 8803766 Ayeshaa.khan1512@gmail.com University of Lahore scientific Ayesha Maroof
1-km Defence Road , near Bhuptian Chowk,Lahore , Punjab
Lahore Pakistan 55150 +92 305 8803766 Ayeshaa.khan1512@gmail.com University of Lahore Pakistan Aged between 18-50 years Both Male and females Patients referred from orthopedic Patients with positive SLR test Having at least 5 score of Numeric Pain Rating Scale 18 years 50 years Both Patients with neurological symptoms (such as cognitive) Patients with inflammatory disorders (rheumatoid arthritis) Patients with specific disorders of spine (ankylosing spondylitis, paget’s disease, vertebral collapse, spondylolisthesis, severe osteoporosis, Tb spine, diabetic neuropathy, stenosis, sacroiliac joint pathology) Patients with previous spinal surgery Current pregnancy or early postpartum period (6 months) M54.16 Radiculopathy, lumbar region Treatment - Other Treatment - Other Intervention group: The participants randomly will be allocated in Group A received the Total motion release. After 15 minutes of heat therapy along with TENS, neural mobilization exercises, consisting of both sliders and tensioners, will be provided. The patient will be positioned in high sitting, with the hands clasped behind and in slouched posture as base position. They will be performed neck extension and knee extension for the sliding technique, and neck flexion with knee extension for the tensioning technique . The movement range will be determined by the severity of symptoms and patient tolerance. The nerve sliding technique will be applied for 20-30 repetitions in 2-3 sets per day, and the nerve tensioning technique will be implemented in addition for 15-25 seconds in 5-7 repetitions. In total motion release treatment is given to unaffected side thus relieving symptoms of affected side with 5 reps & 10 times. It is very simple technique in which patient is made to perform five motion they are (Naik et al., 2019): 1) Arm raise 2) Trunk twist 3) Leg raise 4) Sit to stand and 5) Toe reach. Intervention group: In Group B all allocated participants will be received conventional therapy. Conventional therapy includes 15 minutes of heat therapy along with TENS. Hot packs will be used to deliver superficial heating. Each treatment session will be lasted 30-45 minutes. TENS (Transcutaneous Electrical Nerve Stimulation) sessions will be lasted 15 min. The TENS will be applied in a conventional mode for 15 min at a high frequency of 70 Hz and wavelength of 100 microseconds by placing two 40 × 40 mm electrode sets cross arranged on each side of the lumbosacral spine.The intensity of the current will be increased to the point of observation of no contractions, but with a light tingling sensation, while ensuring the patient will be comfortable. Then mild stretches of hamstrings and piriformis muscle, core stabilization exercises and sciatic nerve mobilization will be done. The pain VAS is a unidimensional measure of pain intensity, used to record patients’ pain progression, or compare pain severity between patients with similar conditions. Timepoint: Before intervention and 2nd , 4th weeks after intervention. Method of measurement: The simplest VAS is a straight horizontal line of fixed length, usually 100 mm. The ends are defined as the extreme limits of the parameter to be measured (symptom, pain, health) orientated from the left (worst) to the right (best). The Oswestry disability Index is most sensitive for patients with mild to moderate disability due to acute, sub-acute, or chronic low back pain. Timepoint: Before intervention and 2nd , 4th weeks after intervention. Method of measurement: The end score is the sum of the ticked boxes. The score ranges from 0 (no disability) to 24 (max. disability) depending on the questionnaire used. Roland and Morris omitted describing the various levels of disability (for example, 40%–60% of disability is severe). The SF-12 is a self-reported outcome measure assessing the impact of health on an individual's everyday life. It is often used as a quality of life measure. Timepoint: Before intervention and 2nd , 4th weeks after intervention. Method of measurement: The SF-12 uses the exact two domains mental and physical health score as the SF-36. Patients fill out a 12-question survey which is then scored by a clinician or researcher. The score ranges from 0 (worst health) to 100 (best health) depending on the questionnaire used. none Approved 2024-05-09 University of Lahore University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan