Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study

Lumbar disc herniation (LDH) is the most frequent cause of lumbosacral radiculopathy and account for 39% of chronic low back pain cases. In approximately 95% of cases LDH occurs at L4-L5 and L5-S1 levels. Maintaining functional stability of lumbar spine necessitates strengthening of the core muscles that plays a key role in lumbar strengthening, motor control and core stability. Core stability may play a role in passive disc stability, reducing the pressure on disc, relieving nerve impingement and radiating pain. Neural mobilization technique involves manual mobilization or exercise that promotes movement between and around the neural structures.This study is intended to add to the existing literature regarding patients with lumbar radiculopathy due to disc herniation, and to report the effectiveness of core stabilization exercises with and without neural mobilization technique in respective population in reduction of associated symptoms, pain and functional disability, enhancing the quality of life, and restoring a prior functional status and activity potential.

Study Overview

• Status: Recruiting
• Conditions: Lumbar Disc Herniation
• Intervention / Treatment: Other: Core stabilization exercises; Other: Core stabilization exercises + neural mobilization technique

Detailed Description

An RCT will be conducted on female patients with radiculopathy due to posterolateral disc herniation at L4-S1 levels, visiting Physiotherapy OPD at DUHS Ojha campus. A sample of 70 patients was calculated using PASS v11 software (Microsoft, Redmond, WA, USA). For estimating sample size, pain scores of motor control group (3.4 ±0.9) and motor control+ NDS group (2.5 ±0.8) after 8th session was used from a study conducted earlier. Patients who fulfill the inclusion criteria will be included in the study through convenience sampling, and will be equally allocated either in Core stabilization exercises group A (Control group: n=35) or Core stabilization exercises with Neural mobilization technique group B (Experimental group: n=35). Treatment will be provided on alternate days 3 times a week for 4 consecutive weeks. Patients will be assessed for pain and functional disability prior to the treatment, then at the end of 2nd week and 4th week through 11 points NPRS and Modified Oswestry Disability Questionnaire (MODQ). Data will be entered and analyzed through IBM SPSS version 24 with p-value < 0.05 will be considered as statistically significant.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Faryah Aslam, DPT; Phone Number: 0321-2318153; Email: fausmanian@gmail.com
• Study Contact Backup: Name: Saba A Ali, DPT, MSAPT; Phone Number: 0300-2886769; Email: saba.aijaz@duhs.edu.pk

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74200
      • Recruiting
      • Dow University of Health Sciences
      • Contact: Faryah Aslam, DPT; Phone Number: 0321-2318153; Email: fausmanian@gmail.com
      • Contact: Saba A Ali, DPT, MSAPT; Phone Number: 03002886769; Email: saba.aijaz@duhs.edu.pk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Diagnosed and referred females with lumbar disc herniation.
2. Have a confirmed L4-S1 lumbar disc herniation through an MRI.
3. Postero-lateral Disc herniation of stage I & II.
4. Age group of 30-50 years.
5. Low back pain radiating to one leg for more than 3 months.
6. Positive SLR test reproducing symptoms between 40°-70°.

Exclusion Criteria:

1. Spondylolisthesis, spondylitis, and spinal canal stenosis.
2. Red flags: spinal tumors, cuada equina syndrome, spinal fractures, osteoporosis, infection.
3. Severe vascular disease like DVT.
4. Pregnancy and Gynecological problems.
5. Psychological disorders affecting subject's ability to follow instructions.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Control group; Core stabilization exercises	Other: Core stabilization exercises; 6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks.
Experimental: Experimental group; Core stabilization exercises and Neural mobilization technique	Other: Core stabilization exercises + neural mobilization technique; 6 core stabilization exercises including: dead bug, side lying, prone, bird dog, bridging, planks (1x10 reps for 15-30 secs each exercise) 3 alternative days a week, for 4 weeks. Neural mobilization technique (SLR intervention for first 2 weeks and slider intervention for last 2 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity	Numeric Pain Rating Scale (11-point NPRS), a commonly used horizontal line scale with two end points to measure pain intensity. 0 indicates no pain at all, while 10 indicates the worst possible pain experienced.	Baseline, 2nd week and 4th week (change is being assessed)
Functional disability	Modified Oswestry Disability Questionnaire (MODQ), a self-administered 10 items questionnaire. Items are questions about pain intensity related to activities of daily living. Each section has a score of 0- 5, 5 demonstrating the greatest disability. The percentage of disability is reported by adding scores of all items and multiplying it by 2. Higher score represents higher pain intensity and disability.	Baseline, 2nd week and 4th week (change is being assessed)

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 6, 2022
• Primary Completion (Anticipated): October 5, 2023
• Study Completion (Anticipated): November 5, 2023

Study Registration Dates

• First Submitted: December 15, 2022
• First Submitted That Met QC Criteria: December 15, 2022
• First Posted (Actual): December 23, 2022

Study Record Updates

• Last Update Posted (Actual): December 30, 2022
• Last Update Submitted That Met QC Criteria: December 28, 2022
• Last Verified: December 1, 2022

More Information

Terms related to this study

• Keywords: Disc herniation; Females; Pain intensity; Lumbar radiculopathy; Functional disability; Core stabilization exerices; Neural mobilization technique
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Peripheral Nervous System Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Hernia; Intervertebral Disc Displacement; Radiculopathy
• Other Study ID Numbers: IRB-2696

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No