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IRCT20241019063426N1 IRCT 2024-12-23 University of Lahore Effect of manual therapy with and without shockwave therapy on lumber disc herniation Effect of manual therapy with and without shockwave therapy on lumber disc herniation in patients with sacroiliac joint dysfunction 2024-07-03 anticipated 72 Complete https://irct.ir/trial/80213 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this randomized controlled trial ,stratified randomization will be used to ensure balanced allocation. A random sequence will be generated using statistical software and group assignments will be concealed in opaque , sealed and sequentially numbered envelopes prepared by an independent researcher. Envelops will be opened only after participant enrollment to maintain allocation concealment and avoid bias, Blinding description: This study is single blinded study in which assessor will be remain unaware of the treatment group while assessing but patients will know about the whole procedure. N/A Sacroiliac joint dysfunction refers to abnormal movement or inflammation in the sacroiliac joint, causing pain in the lower back and pelvis. It often results from trauma, misalignment, or excessive stress on the joint.. Intervention 1: Intervention group: Patients in Group A will be received ESWT using the Shockwave Therapy Machine In the MT group, interventions will be as follows: Patients will be assumed a prone position, during which the operator will be administered a massage and apply pressure to the affected lumbosacral muscles (latissimus dorsi, erector spinae, multifidus, gluteus Maximus, gluteus medius, iliopsoas, lateral external oblique muscle, and internal oblique muscle) for approximately 10 minutes. When a cord-like painful nodule at the SIJ is touched, the operator will be flipped the nodule with their thumb and gently push it obliquely upward or downward until the nodule reduces or disappears. Subsequently, the patient will be transitioned to a supine position, and their lower limb will be straightened and subjected to a ring-like shaking motion 6–7 times. The patient's affected side will be then positioned beneath the operator's arm, and they will be received forward-bending traction for 1 minute, involving flexion of the knees and hip, as well as adduction of the hip joint. Finally, the operator will be positioned the patient in lateral decubitus on the healthy side and instruct them to flex their knees and hips. The operator will be then applying pressure and movement to the affected side of the sacroiliac joint (SIJ), followed by straightening the affected extremity. This treatment process will be repeated 3–5 times. Subsequently, the patients will be instructed to assume the prone position, and various assessments, including measuring the height of the posterior superior iliac spine, evaluating painful cord-like nodules, conducting the "4" test, and performing point of care testing, will be performed to assess the degree of SIJ dysfunction. And some lumbar stretching exercises (including bridges, knee to chest, press-up back extensions, and bird dogs) and exercises for strengthening core muscles (partial crunches, pelvic tilts, wall sits, hip stretches) will be assigned to the patients for 10 minutes. Intervention 2: Intervention group: In group B, patients will be received manual therapy only, following the interventions will be same , Patients will be assumed a prone position, during which the operator will be administered a massage and apply pressure to the affected lumbosacral muscles for approximately 10 minutes. When a cord-like painful nodule at the SIJ is touched, the operator will be flipped the nodule with their thumb and gently push it obliquely upward or downward until the nodule reduces or disappears. Subsequently, the patient will be transition to a supine position, and their lower limb will be straightened and subjected to a ring-like shaking motion 6–7 times. The patient's affected side will be then positioned beneath the operator's arm, and they will be received forward-bending traction for 1 minute, involving flexion of the knees and hip, as well as adduction of the hip joint. Finally, the operator will be positioned the patient in lateral decubitus on the healthy side and instruct them to flex their knees and hips. The operator will be then applying pressure and movement to the affected side of the sacroiliac joint (SIJ), followed by straightening the affected extremity. This treatment process will be repeated 3–5 times. And some lumbar stretching exercises (including bridges, knee to chest, press-up back extensions, and bird dogs) and exercises for strengthening core muscles (partial crunches, pelvic tilts, wall sits, hip stretches) will be assigned to the patients for 10 minutes. 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: Sana Conditions: For research purpose Where to obtain: To the correspondiong author of the study,Sana and can contact on Drsanasana986@gmail.com , +92 335 4553087 How to obtain: Open access and there is the traditional public data release where anyone can get access to the data Comments:
public Sana
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
Lahore Pakistan 55150 +92 335 4552087 Drsanasana987@gmail.com University of Lahore scientific Sana
University of Lahore Teaching Hospital Lahore , Punjab , Pakistan
Lahore Pakistan 55150 +92 335 4552087 Drsanasana986@gmail.com University of Lahore Pakistan Participants aged ≥ 18 years Both male and female patients Chronic low back pain lasting over 3 months Pain localized in unilateral sacroiliac joint Presence of muscle spasm around the sacroiliac joint Limited activity of lower limbs and inability to sit for extended periods Positive findings on pelvic compression and separation tests, the "4" test, and one-foot standing test 18 years no limit Both Patients experiencing pain in the waist and legs from alternative etiologies Pregnant individuals Individuals with tuberculosis affecting the sacroiliac joint or spine Participants with inflammatory conditions such as ankylosing spondylitis Individuals with sacroiliac joint sprain characterized by symmetrical bone marks and no abnormalities observed in X-ray images S33.6XXA Sprain of sacroiliac joint, initial encounter Treatment - Other Treatment - Other Intervention group: Patients in Group A will be received ESWT using the Shockwave Therapy Machine In the MT group, interventions will be as follows: Patients will be assumed a prone position, during which the operator will be administered a massage and apply pressure to the affected lumbosacral muscles (latissimus dorsi, erector spinae, multifidus, gluteus Maximus, gluteus medius, iliopsoas, lateral external oblique muscle, and internal oblique muscle) for approximately 10 minutes. When a cord-like painful nodule at the SIJ is touched, the operator will be flipped the nodule with their thumb and gently push it obliquely upward or downward until the nodule reduces or disappears. Subsequently, the patient will be transitioned to a supine position, and their lower limb will be straightened and subjected to a ring-like shaking motion 6–7 times. The patient's affected side will be then positioned beneath the operator's arm, and they will be received forward-bending traction for 1 minute, involving flexion of the knees and hip, as well as adduction of the hip joint. Finally, the operator will be positioned the patient in lateral decubitus on the healthy side and instruct them to flex their knees and hips. The operator will be then applying pressure and movement to the affected side of the sacroiliac joint (SIJ), followed by straightening the affected extremity. This treatment process will be repeated 3–5 times. Subsequently, the patients will be instructed to assume the prone position, and various assessments, including measuring the height of the posterior superior iliac spine, evaluating painful cord-like nodules, conducting the "4" test, and performing point of care testing, will be performed to assess the degree of SIJ dysfunction. And some lumbar stretching exercises (including bridges, knee to chest, press-up back extensions, and bird dogs) and exercises for strengthening core muscles (partial crunches, pelvic tilts, wall sits, hip stretches) will be assigned to the patients for 10 minutes. Intervention group: In group B, patients will be received manual therapy only, following the interventions will be same , Patients will be assumed a prone position, during which the operator will be administered a massage and apply pressure to the affected lumbosacral muscles for approximately 10 minutes. When a cord-like painful nodule at the SIJ is touched, the operator will be flipped the nodule with their thumb and gently push it obliquely upward or downward until the nodule reduces or disappears. Subsequently, the patient will be transition to a supine position, and their lower limb will be straightened and subjected to a ring-like shaking motion 6–7 times. The patient's affected side will be then positioned beneath the operator's arm, and they will be received forward-bending traction for 1 minute, involving flexion of the knees and hip, as well as adduction of the hip joint. Finally, the operator will be positioned the patient in lateral decubitus on the healthy side and instruct them to flex their knees and hips. The operator will be then applying pressure and movement to the affected side of the sacroiliac joint (SIJ), followed by straightening the affected extremity. This treatment process will be repeated 3–5 times. And some lumbar stretching exercises (including bridges, knee to chest, press-up back extensions, and bird dogs) and exercises for strengthening core muscles (partial crunches, pelvic tilts, wall sits, hip stretches) will be assigned to the patients for 10 minutes. 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: 4th week. 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 Back Pain Functional Scale (BPFS) is a subjective measure developed by Stratford et al. in 2000 to assess physical function during the initial weeks of low back pain episodes. Timepoint: 4th week. Method of measurement: The total score out of 60 indicates physical abilities, with a higher score representing greater functionality. Additionally, an ‘Adjusted score’ ranges from 0 to 60, reflecting the ability to perform activities, with 0 indicating inability and 60 indicating no difficulty. 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: 4th week. 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. None Approved 2024-08-13 Research Ethics Committee of University of Lahore University of Lahore Teaching Hospital Lahore , Punjab , Pakistan Lahore Punjab Pakistan