NCT07730502

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 17, 2026

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2026

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 7, 2026

Completed
16 days until next milestone

First Submitted

Initial submission to the registry

July 23, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 28, 2026

Completed
Last Updated

July 28, 2026

Status Verified

July 1, 2026

Enrollment Period

5 months

First QC Date

July 23, 2026

Last Update Submit

July 23, 2026

Conditions

Keywords

McKenzie extension, core stability exercises, spinal decompression, discogenic low back pain, lumbar radiculopathy, NPRS, ODI

Outcome Measures

Primary Outcomes (3)

  • Pain Intensity

    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.

    Baseline and after 4 weeks of intervention

  • Functional Disability - Oswestry Disability Index (ODI)

    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

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

Study Arms (2)

Group A (McKenzie Extension Protocol with Spinal Decompression)

EXPERIMENTAL

Participants will receive mechanical spinal decompression followed by a McKenzie Extension Protocol, including prone lying with lumbar extension, prone press-ups, standing lumbar extension, and repeated end-range extension exercises based on directional preference. Adjunct therapy includes moist heat and interferential current. Treatment will be administered three sessions per week for four weeks (12 sessions total).

Procedure: McKenzie Extension ProtocolProcedure: Spinal decompression, Moist heat, interferential current

Group B (Core Stability Exercises with Spinal Decompression)

ACTIVE COMPARATOR

Participants will receive the same spinal decompression protocol followed by a Core Stability Exercise program consisting of abdominal drawing-in maneuvers, bridging, bird-dog, and side plank exercises. Adjunct therapy includes moist heat and interferential current. Treatment will be administered three sessions per week for four weeks (12 sessions total).

Procedure: Core stability ExerciseProcedure: Spinal decompression, Moist heat, interferential current

Interventions

McKenzie Extension Protocol: prone lying extension, prone press-ups, standing lumbar extension, and repeated end-range extension based on directional preference. 3 sessions/week for 4 weeks (12 sessions total).

Group A (McKenzie Extension Protocol with Spinal Decompression)

Core Stability Exercises: abdominal drawing-in maneuver, bridging, quadruped bird-dog, and side plank/modified side support 3 sessions/week for 4 weeks (12 sessions total).

Group B (Core Stability Exercises with Spinal Decompression)

Spinal decompression: mechanical traction, supine, 25-50% bodyweight, 10-15 min, intermittent 60s hold/30s release. Moist heat (10-15 min) Interferential current (IFC, 10-15 min, 80-100 Hz). 3 sessions/week for 4 weeks (12 sessions total).

Group A (McKenzie Extension Protocol with Spinal Decompression)Group B (Core Stability Exercises with Spinal Decompression)

Eligibility Criteria

Age25 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Max Spine Rehab Center, Max Health Hospital

Islamabad, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Interventions

Laminectomy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

Orthopedic ProceduresTherapeuticsDecompression, SurgicalSurgical Procedures, OperativeNeurosurgical Procedures

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 23, 2026

First Posted

July 28, 2026

Study Start

January 17, 2026

Primary Completion

June 8, 2026

Study Completion

July 7, 2026

Last Updated

July 28, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Locations