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 Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05663437
• Other study ID #: IRB-2696
• Status: Recruiting
• Phase: N/A
• Start date: October 6, 2022
• Est. completion date: November 5, 2023

Study information

• Verified date: December 2022
• Source: Dow University of Health Sciences
• Contact: Faryah Aslam, DPT
• Phone: 0321-2318153
• Email: fausmanian[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: November 5, 2023
• Est. primary completion date: October 5, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 30 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hernia
• Intervertebral Disc Displacement
• Lumbar Disc Herniation
• Radiculopathy

Intervention

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.
• 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).

Locations

Country	Name	City	State
Pakistan	Dow University of Health Sciences	Karachi	Sindh

Sponsors (1)

Lead Sponsor	Collaborator
Dow University of Health Sciences

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)