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临床试验/NCT07730502
NCT07730502已完成不适用

McKenzie Versus Core Stability Exercises Along With Spinal Decompression in Discogenic Lumbar Radiculopathy: A Single-Blind Randomized Controlled Trial

Ibadat International University, Islamabad1 个研究点 分布在 1 个国家目标入组 42 人开始时间: 2026年1月17日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
42
试验地点
1
主要终点
Pain Intensity

研究概览

简要总结

The pathophysiology arises from structural and biochemical degeneration within the intervertebral disc rather than direct nerve root compression alone. When radicular symptoms are present, patients frequently experience a combination of localized lumbar pain, radiating leg pain, reduced spinal mobility, and impaired daily function. Non-surgical spinal decompression therapy is frequently employed as a conservative treatment for lumbar disc pathology due to its capacity to reduce intradiscal pressure, increase disc height, and unload compressed neural structures. Nevertheless, decompression alone does not fully restore neuromuscular control or spinal stability; it is consequently commonly paired with an active exercise approach. Two of the most widely utilized adjunct approaches are the McKenzie Extension Protocol, which employs directional-preference movements and repeated end-range loading to promote symptom centralization, and Core Stability Exercises, which target the deep trunk stabilizers to improve segmental control of the lumbar spine. Although each approach is independently supported by evidence, no recent trial has directly compared their effectiveness when each is combined with spinal decompression therapy in patients with MRI-confirmed discogenic low back pain accompanied by radiculopathy. This evidence gap consequently leaves clinicians without clear guidance on which combined strategy to select.

The present study is a single-blind randomized controlled trial designed to determine and compare the effects of the McKenzie Extension Protocol versus Core Stability Exercises, each combined with spinal decompression therapy, on pain intensity, functional disability, and lumbar range of motion in adults with MRI-confirmed discogenic low back pain and radiculopathy. Forty-two participants aged 25-45 years, with a posterolateral disc bulge confirmed on MRI, a Numeric Pain Rating Scale (NPRS) score greater than 3, and a positive Straight Leg Raise test, will be recruited using purposive sampling and randomly allocated by lottery method into two equal groups of 21. Group A will receive spinal decompression therapy followed by McKenzie extension-based exercises, while Group B will receive the same decompression protocol followed by core stabilization exercises such as abdominal drawing-in, bridging, bird-dog, and side-plank variations. Both groups will also receive standardized adjunct modalities, including moist heat and interferential current therapy, and will attend three sessions per week for four consecutive weeks, totaling 12 sessions.

Outcomes will be assessed at baseline and immediately after the four-week intervention period by a blinded assessor to minimize bias. The primary outcome measures include pain intensity (NPRS), functional disability (Oswestry Disability Index), lumbar range of motion (inclinometer), and lower-limb neural mobility (Straight Leg Raise angle). Data will be analyzed using SPSS to compare within-group and between-group changes across the two interventions.

This trial is anticipated to generate direct comparative evidence on which combined rehabilitation strategy, either decompression with McKenzie exercises or decompression with core stability exercises, produces superior clinical outcomes for this patient population. Given that current clinical guidelines do not specify a preferred adjunct approach for discogenic radiculopathy managed with decompression, the findings are intended to assist physiotherapists in selecting more targeted, evidence-based rehabilitation protocols. Such evidence may potentially improve pain relief, functional recovery, and cost-effectiveness of care, while simultaneously reducing the long-term burden associated with chronic low back pain.

详细描述

Background and Rationale

Low back pain (LBP) ranks among the most prevalent musculoskeletal conditions globally. Point prevalence estimates are roughly 9-12% worldwide, with up to 23% of adults reporting an episode within a one-month period. Lifetime prevalence estimates range as high as 40-80%. Global burden data from 2021 indicate that approximately 453 million working-age adults were affected by LBP. Within this broad population, discogenic low back pain (DLBP) constitutes a distinct subgroup in which pain originates from structural and biochemical changes within the intervertebral disc itself, most often disc degeneration, rather than from nerve root compression or other spinal pathology. Depending on the diagnostic method employed, discogenic pain accounts for approximately 22-50% of chronic low back pain cases. A further subset of these patients develops lumbar radiculopathy, wherein nerve root irritation produces radiating leg pain. Population data suggest that roughly 12% of adults with back pain exhibit clinical radiculopathy, though substantial variation in reported incidence exists depending on the population studied.

Non-surgical spinal decompression is a motorized, computer-controlled traction therapy that applies gentle, feedback-regulated distraction forces to the lumbar spine. It is theorized to reduce intradiscal pressure, transiently increase disc height and foraminal space, and enhance fluid and nutrient exchange within the disc, thereby supporting disc hydration and reducing mechanical loading on degenerated segments. Several recent studies report improvements in pain and disability following non-surgical decompression, particularly when it is combined with conventional physical therapy rather than used in isolation.

Two of the most established adjunct exercise approaches utilized alongside decompression are the McKenzie Method, also known as Mechanical Diagnosis and Therapy (MDT), and Core Stability Exercises. The McKenzie approach is a structured system of repeated movements and sustained positions used to classify patients into mechanical subgroups and guide treatment based on their directional preference. A central therapeutic phenomenon in this approach is centralization, in which distally referred pain progressively retreats toward the spinal midline in response to specific repeated movements, a pattern associated with favorable prognosis. Core stability exercises, by contrast, focus on activating and coordinating the deep trunk musculature, including the transversus abdominis and lumbar multifidus, to improve co-contraction, segmental control, and postural stability, thereby reducing nociceptive input from unstable or overloaded spinal structures.

Existing comparative literature remains mixed. Some studies report that core stabilization produces greater reductions in pain and disability than McKenzie exercises in patients with lumbar radiculopathy, while other trials, including a one-year follow-up RCT among patients with a McKenzie directional preference, found no clear superiority of either approach when compared to motor control or core stability exercises. Evidence specific to discogenic radiculopathy managed with decompression is even more limited. One RCT found that adding spinal decompression to core stabilization produced larger within-group improvements than core stabilization alone, yet no identified trial has directly compared McKenzie-based and core-stability-based exercise protocols when both are paired with decompression therapy in this specific population.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
25 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Adults aged 25-45 years (both males and females)
  • MRI-confirmed posterolateral disc bulge
  • Pain intensity greater than 3 on the Numeric Pain Rating Scale (NPRS) with radiculopathy
  • Positive Straight Leg Raise (SLR) test

排除标准

  • History of spinal surgery or significant spinal trauma
  • Increased kyphosis or active infectious disease
  • Pregnancy, scoliosis, or systemic inflammatory conditions
  • Cognitive impairments that may interfere with participation or assessment

结局指标

主要结局

Pain Intensity

时间窗: Baseline and after 4 weeks of intervention

Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point self-reported scale ranging from 0 (no pain) to 10 (worst imaginable pain). A reduction in NPRS score indicates improvement in pain intensity.

Functional Disability - Oswestry Disability Index (ODI)

时间窗: 10-item self-reported questionnaire scored as a percentage of disability; assessed at baseline and post-intervention (4 weeks).

Lumbar Range of Motion - Inclinometer Measurement

时间窗: Flexion, extension, and left/right side bending measured in degrees using a dual inclinometer; assessed at baseline and post-intervention (4 weeks).

次要结局

未报告次要终点

研究者

发起方
Ibadat International University, Islamabad
申办方类型
Other
责任方
Sponsor

研究点 (1)

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