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

August 31, 2023 updated by: Waseem Javaid, Sehat Medical Complex

Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy. A Randomized Controlled Trial

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.

Study Overview

Status

Completed

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.

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Punjab
      • Lahore, Punjab, Pakistan
        • Sehat Medical Complex

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Core strengthening group
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)

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.

Sham Comparator: Conventional treatment group
Group B were given only Standard Physical Therapy treatment.
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Lower extremity functional pain scale (change is being assessed)
Time Frame: Change from baseline after 12 weeks
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.
Change from baseline after 12 weeks
Oswestry disability index(change is being assessed)
Time Frame: Change from baseline after 12 weeks
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
Change from baseline after 12 weeks
visual analog scale (change is being assessed)
Time Frame: Change from baseline after 12 weeks
A Visual Analogue Scale (VAS) is one of the pain rating scales. It measures pain at line of 10cm.
Change from baseline after 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Hassan Javaid, University of Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 4, 2023

Primary Completion (Actual)

July 28, 2023

Study Completion (Actual)

August 16, 2023

Study Registration Dates

First Submitted

February 14, 2023

First Submitted That Met QC Criteria

February 14, 2023

First Posted (Actual)

February 23, 2023

Study Record Updates

Last Update Posted (Actual)

September 5, 2023

Last Update Submitted That Met QC Criteria

August 31, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • hassanjavaid19

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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