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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

Primary Purpose

Lumbar Disc Herniation

Status
Recruiting
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Core stabilization exercises
Core stabilization exercises + neural mobilization technique
Sponsored by
Dow University of Health Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar radiculopathy, Disc herniation, Pain intensity, Functional disability, Core stabilization exerices, Neural mobilization technique, Females

Eligibility Criteria

30 Years - 50 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: 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°. Exclusion Criteria: 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.

Sites / Locations

  • Dow University of Health SciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control group

Experimental group

Arm Description

Core stabilization exercises

Core stabilization exercises and Neural mobilization technique

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 15, 2022
Last Updated
December 28, 2022
Sponsor
Dow University of Health Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT05663437
Brief Title
Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study
Official Title
Effectiveness of Core Stabilization Exercises With and Without Neural Mobilization Technique in Female Patients With Lumbar Radiculopathy Due to Disc Herniation - an RCT Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 6, 2022 (Actual)
Primary Completion Date
October 5, 2023 (Anticipated)
Study Completion Date
November 5, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Dow University of Health Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar radiculopathy, Disc herniation, Pain intensity, Functional disability, Core stabilization exerices, Neural mobilization technique, Females

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Core stabilization exercises
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Core stabilization exercises and Neural mobilization technique
Intervention Type
Other
Intervention Name(s)
Core stabilization exercises
Intervention Description
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
Intervention Name(s)
Core stabilization exercises + neural mobilization technique
Intervention Description
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).
Primary Outcome Measure Information:
Title
Pain intensity
Description
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.
Time Frame
Baseline, 2nd week and 4th week (change is being assessed)
Title
Functional disability
Description
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.
Time Frame
Baseline, 2nd week and 4th week (change is being assessed)

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
30 -50 years of age
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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°. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Faryah Aslam, DPT
Phone
0321-2318153
Email
fausmanian@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Saba A Ali, DPT, MSAPT
Phone
0300-2886769
Email
saba.aijaz@duhs.edu.pk
Facility Information:
Facility Name
Dow University of Health Sciences
City
Karachi
State/Province
Sindh
ZIP/Postal Code
74200
Country
Pakistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Faryah Aslam, DPT
Phone
0321-2318153
Email
fausmanian@gmail.com
First Name & Middle Initial & Last Name & Degree
Saba A Ali, DPT, MSAPT
Phone
03002886769
Email
saba.aijaz@duhs.edu.pk

12. IPD Sharing Statement

Plan to Share IPD
No

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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

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