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

NCT ID: NCT05663437

Last Updated: 2022-12-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-06

Study Completion Date

2023-11-05

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Lumbar Disc Herniation

Keywords

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Core stabilization exercises

Group Type ACTIVE_COMPARATOR

Core stabilization exercises

Intervention Type 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.

Experimental group

Core stabilization exercises and Neural mobilization technique

Group Type EXPERIMENTAL

Core stabilization exercises + neural mobilization technique

Intervention Type 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).

Interventions

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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.

Intervention Type 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).

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dow University of Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Faryah Aslam

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Dow University of Health Sciences

Karachi, Sindh, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Faryah Aslam, DPT

Role: CONTACT

Phone: 0321-2318153

Email: [email protected]

Saba A Ali, DPT, MSAPT

Role: CONTACT

Phone: 0300-2886769

Email: [email protected]

Facility Contacts

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Faryah Aslam, DPT

Role: primary

Saba A Ali, DPT, MSAPT

Role: backup

Other Identifiers

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IRB-2696

Identifier Type: -

Identifier Source: org_study_id