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

NCT05663437 | Unknown

• 1 other identifier: IRB-2696
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disc Herniation

Keywords

Lumbar radiculopathy; Disc herniation; Pain intensity; Functional disability; Core stabilization exerices; Neural mobilization technique; Females

Outcome Measures

Primary Outcomes (2)

• 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)

Study Arms (2)

Control group

ACTIVE COMPARATOR

Core stabilization exercises

Other: Core stabilization exercises

Experimental group

EXPERIMENTAL

Core stabilization exercises and Neural mobilization technique

Other: Core stabilization exercises + neural mobilization technique

Interventions

Core stabilization exercises OTHER

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.

Control group

Core stabilization exercises + neural mobilization technique OTHER

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).

Experimental group

Eligibility Criteria

• Age: 30 Years - 50 Years
• Gender Eligibility Details: 30 -50 years of age
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Dow University of Health Sciences

Karachi, Sindh, 74200, Pakistan

RECRUITING

MeSH Terms

Conditions

Intervertebral Disc Displacement; Radiculopathy; Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms

Central Study Contacts

Faryah Aslam, DPT

CONTACT

0321-2318153; fausmanian@gmail.com

Saba A Ali, DPT, MSAPT

CONTACT

0300-2886769; saba.aijaz@duhs.edu.pk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: December 23, 2022
• Study Start: October 6, 2022
• Primary Completion: October 5, 2023
• Study Completion: November 5, 2023
• Last Updated: December 30, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)