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IRCT20230212057390N5 IRCT 2026-01-26 Mashhad University of Medical Sciences The Effect of Prone Knee Extension Exercise on Lumbar Disc Herniation Pain The Effectiveness of Prone Knee Extension Exercise on Pain Intensity in Patients with Lumbar Disc Herniation: A Randomized Clinical Trial 2025-12-31 anticipated 34 Recruiting https://irct.ir/trial/87849 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Method: Blocked (Block Randomization) Method and Description: This study employed block randomization (blocked randomization). In this method, participants are grouped into blocks of fixed or variable sizes, and within each block, allocation to study groups (e.g., intervention and control groups) is performed randomly and in a balanced manner. This ensures that at any point in time, the number of participants in each group is approximately equal, maintaining group balance throughout the study. Unit of Randomization: The unit of randomization in this study was individual. Each eligible participant was independently assigned to one of the study groups. Stratification: Stratified randomization was used in conjunction with the block method. Participants were divided into separate strata based on important outcome-predicting variables (such as age (age categories) and disease severity (mild/moderate/severe)). Within each stratum, an independent block randomization process was conducted to ensure group balance within each key subgroup. Randomization Tool: The allocation sequence was generated using the statistical software R (utilizing specialized packages such as blockrand or randomizeR). This software enables the creation of stratified block randomization sequences with precision and without bias. Sequence Generation Process: An independent statistician, not involved in subsequent stages of the study (such as evaluation or intervention), generated the allocation sequences. The steps were as follows: The block size (e.g., 4, 6, or 8) and the number of groups (2 groups) were defined. For each stratum (a specific combination of age and disease severity variables), a separate block randomization sequence was generated. This sequence specified the exact order of group allocation (e.g., A=intervention, B=control) for each participant in that stratum. Allocation Concealment: To ensure that the enrolling researcher or the participant could not predict or influence future allocation, the Sequentially Numbered, Opaque, Sealed Envelopes (SNOSE) method was used: The generated allocation for each registration number was placed in a separate, opaque, and sealed envelope. The envelopes were arranged in sequential order according to the participants' entry sequence. After obtaining informed consent and final confirmation of eligibility, the enrolling researcher opened the corresponding sequentially numbered envelope and assigned the participant to the designated group as indicated inside the envelope. This process prevented any manipulation or prediction of allocation, thereby enhancing the internal validity of the study. 3 Condition 1: (hernia disc with radiculopathy). Condition 2: (hernia disc without radiculopathy). Intervention 1: Intervention group: The intervention group received a combined program of general exercises along with the specific PKE (Prone Knee Extension) exercise. The details were as follows: Common Baseline Treatment: 10 sessions of standard physiotherapy (ultrasound, TENS, superficial heat).General Exercises: A 10-15 minute program including stretching and strengthening exercises for the back and hamstring muscles. Specific PKE Exercise: Performing the Prone Knee Extension exercise for 15-20 minutes per session, following a five-stage progressive protocol (from a no-resistance state to adding a 5 kg weight).Home Program: Performing the PKE exercise at home, twice daily. Intervention 2: Control group: The control group received only general exercises. The details of this group's intervention are as follows: Common Baseline Treatment: This group, similar to the intervention group, received 10 sessions of standard physiotherapy (including ultrasound, TENS, and superficial heat) three times per week. General Exercises: This group's exercise program was a structured 10 to 15-minute program including the following: Stretching of the back and hamstring muscles. Lumbar extension exercises (such as prone on elbows and prone press-ups).Lumbar flexion exercises (such as double knee-to-chest stretches and posterior pelvic tilts).Method of Execution: All exercises were individually tailored according to each patient's condition and performed under the direct supervision of a physiotherapist within a pain-free range. Exercise progression was based on the principle of Progressive Overload. No Additional Intervention: This group did not receive the specific PKE (Prone Knee Extension) exercise or its associated home exercise program. Summary: The control group received only the common physiotherapy protocol (including physical modalities and a general exercise program), while the intervention group additionally performed the specific PKE exercise. 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 Based on a written request to the university
public Majid Shahbazi
Department of Physical Therapy-School of Paramedical and Rehabilitation Sciences-University campus-Azadi square-Mashhad-Iran
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 shahbazim2@mums.ac.ir Mashhad University of Medical Sciences scientific Majid Shahbazi
Department of Physical Therapy-School of Paramedical and Rehabilitation Sciences-University campus-Azadi square-Mashhad-Iran
Mashhad Iran (Islamic Republic of) 9177948964 +98 51 3884 6710 shahbazim2@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Report of increased pain during activities such as forward bending, coughing, sneezing, or prolonged sitting. Pain reduction while lying down Presence of lower lumbar disc herniation on MRI imaging with confirmation by clinical examination Possession of the necessary cognitive abilities to participate in various aspects of the study. 20 years 60 years Both Acute pain in the hip, back, or knee within the past two weeks Presence of any specific disorder related to the sacroiliac joint and facet joint syndrome History of surgery or fracture in the spine, hip, or knee Presence of pre-existing congenital hip joint disorders Presence of red flags indicating conditions such as tumors, infections, or cauda equina syndrome Presence of cautionary signs related to maladaptive pain coping strategies A score above 37 on the Tampa Scale for Kinesiophobia (TSK) Presence of spinal stenosis History of neurological disorders affecting the musculoskeletal system and other serious conditions associated with impaired joint movement 51.2M M 51.3 فتق‌های دیسک بین مهره‌ای با رادیکولوپاتی فتق‌های دیسک بین مهره‌ای بدون رادیکولوپاتی Treatment - Other Treatment - Other Intervention group: The intervention group received a combined program of general exercises along with the specific PKE (Prone Knee Extension) exercise. The details were as follows: Common Baseline Treatment: 10 sessions of standard physiotherapy (ultrasound, TENS, superficial heat).General Exercises: A 10-15 minute program including stretching and strengthening exercises for the back and hamstring muscles. Specific PKE Exercise: Performing the Prone Knee Extension exercise for 15-20 minutes per session, following a five-stage progressive protocol (from a no-resistance state to adding a 5 kg weight).Home Program: Performing the PKE exercise at home, twice daily. Control group: The control group received only general exercises. The details of this group's intervention are as follows: Common Baseline Treatment: This group, similar to the intervention group, received 10 sessions of standard physiotherapy (including ultrasound, TENS, and superficial heat) three times per week. General Exercises: This group's exercise program was a structured 10 to 15-minute program including the following: Stretching of the back and hamstring muscles. Lumbar extension exercises (such as prone on elbows and prone press-ups).Lumbar flexion exercises (such as double knee-to-chest stretches and posterior pelvic tilts).Method of Execution: All exercises were individually tailored according to each patient's condition and performed under the direct supervision of a physiotherapist within a pain-free range. Exercise progression was based on the principle of Progressive Overload. No Additional Intervention: This group did not receive the specific PKE (Prone Knee Extension) exercise or its associated home exercise program. Summary: The control group received only the common physiotherapy protocol (including physical modalities and a general exercise program), while the intervention group additionally performed the specific PKE exercise. Pain. Timepoint: Before and after the intervention. Method of measurement: Visual Analogue Scale. Disability. Timepoint: Before and after the intervention. Method of measurement: Oswestry Disability Index. Quality of life. Timepoint: Before and after the intervention. Method of measurement: Short Form-36. Hamstring tightness. Timepoint: Before and after the intervention. Method of measurement: Active Straight Leg Raise. Lumbar lordosis. Timepoint: Before and after the intervention. Method of measurement: Flexible ruler. Lumbar range of motion. Timepoint: Before and after the intervention. Method of measurement: Schober test and trunk flexibility measurement. Mashhad University of Medical Sciences Approved 2025-11-16 Ethics committee of Mashhad University of Medical Sciences Shahid Khwarazmi Educational Complex, Faculty of Paramedical Sciences and Rehabilitation, Department of Physiotherapy, University Campus, Azadi Square, Mashhad. mashhad Razavi Khorasan Iran (Islamic Republic of)