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Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy

Primary Purpose

Lumbar Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
Core strengthening
Conventional treatment
Sponsored by
Sehat Medical Complex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Radiculopathy

Eligibility Criteria

40 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 45-65 years Both genders Low back pain radiating towards calf for more than 2 months (diagnosed by the orthopedic surgeon) Exclusion Criteria: Patients with Inflammatory, infectious, malign or metabolic diseases Patients with osteoporosis, neurological defects, calf muscle hypertrophy, cardiovascular disorders any spinal or leg operations Pregnancy Any traumatic History

Sites / Locations

  • Sehat medical Complex

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Core strengthening group

Conventional treatment group

Arm Description

Group A were given the Standard Physical Therapy Treatment along with core strengthening exercises Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability)

Group B were given only Standard Physical Therapy treatment.

Outcomes

Primary Outcome Measures

Lower extremity functional pain scale (change is being assessed)
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.
Oswestry disability index(change is being assessed)
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
visual analog scale (change is being assessed)
A Visual Analogue Scale (VAS) is one of the pain rating scales. It measures pain at line of 10cm.

Secondary Outcome Measures

Full Information

First Posted
February 14, 2023
Last Updated
August 31, 2023
Sponsor
Sehat Medical Complex
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1. Study Identification

Unique Protocol Identification Number
NCT05741138
Brief Title
Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy
Official Title
Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy. A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 4, 2023 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
August 16, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sehat Medical Complex

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
The goal of this Randomized controlled trial was to examine the effect of routine physical therapy with and without core stability exercises in patients with lumbar radiculopathy. The main question it aims to answer is: • To examine the effect of routine physical therapy with and without core stability exercises in patients with lumbar radiculopathy Participants after reading and signing the consent form were included in study according to eligibility criteria and were allocated in to 2 groups, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability). We measured outcome through different outcome measure tools.
Detailed Description
Lumbar radiculopathy (LR) is defined as spinal nerve-related symptoms such as back and leg pain, with variable presence of paraesthesias, reflex changes, and secondary interference of normal activities. Lumbar radiculopathy (LR) is a common debilitating condition of lumbar origin which influences both the general population and athletes alike. Its prevalence has been estimated to be 3-5% of the population, affecting both men and women. Core strengthening exercises (CSE) are used to train, strengthen and condition the core muscles surrounding the middle of the body i.e. the abdomen, hips, pelvis and lower back. CSE trains muscle activity patterns without unnecessarily overloading the tissue, and can help to stabilize the spine. Core strengthening exercises were applied on patient with lumbar radiculopathy and calf pain to see whether it helps to reduce pain or not. Participants were given consent form and after subjects read and sign the informed consent, they were included in study according to eligibility criteria. 2 groups were included in study, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability). We measured outcome through different outcome measure tools.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Core strengthening group
Arm Type
Experimental
Arm Description
Group A were given the Standard Physical Therapy Treatment along with core strengthening exercises Core strengthening exercises were carried out in their respective standard positions (were modified according to patient's comfortability)
Arm Title
Conventional treatment group
Arm Type
Sham Comparator
Arm Description
Group B were given only Standard Physical Therapy treatment.
Intervention Type
Other
Intervention Name(s)
Core strengthening
Intervention Description
Plank 1-3 sets of 10-15 reps per side at a slow tempo Side plank Draw in and lift, holding for 5 seconds with purposeful engagement of the core and leg musculature. Keep the head, shoulders, hips, knees and feet in a straight line. Bridges - Lie supine with your knees bent and the feet flat on the floor. Lift your pelvis off the ground while supporting on your feet and shoulders. The bridge can be progressed by lifting one foot off the ground end extending the knee Leg rises - Lie on your back with your legs straight and your arms by your sides. Then lift one leg 4 inches of the ground. Your back has to stay flat on the floor. Don't allow it to arch. Alternate. The exercise can be progressed by lifting both legs at the same time.
Intervention Type
Other
Intervention Name(s)
Conventional treatment
Intervention Description
Hot pack and TENS for 10 minutes (lumbar region and calf muscles) Ultrasound for 10 mins (lumbar region and calf muscles) Gentle passive stretching (calf muscles) Isometric exercises (lumbar region)
Primary Outcome Measure Information:
Title
Lower extremity functional pain scale (change is being assessed)
Description
The Lower Extremity Functional Scale (LEFS) is a questionnaire containing 20 questions about a person's ability to perform everyday tasks. The LEFS can be used by clinicians as a measure of patients' initial function, ongoing progress and outcome, as well as to set functional goals.
Time Frame
Change from baseline after 12 weeks
Title
Oswestry disability index(change is being assessed)
Description
The Oswestry Disability Index (also known as the Oswestry Low Back Pain Disability Questionnaire) is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Time Frame
Change from baseline after 12 weeks
Title
visual analog scale (change is being assessed)
Description
A Visual Analogue Scale (VAS) is one of the pain rating scales. It measures pain at line of 10cm.
Time Frame
Change from baseline after 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 45-65 years Both genders Low back pain radiating towards calf for more than 2 months (diagnosed by the orthopedic surgeon) Exclusion Criteria: Patients with Inflammatory, infectious, malign or metabolic diseases Patients with osteoporosis, neurological defects, calf muscle hypertrophy, cardiovascular disorders any spinal or leg operations Pregnancy Any traumatic History
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hassan Javaid
Organizational Affiliation
University of Lahore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sehat medical Complex
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Learn more about this trial

Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy

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