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

Sponsor
Sehat Medical Complex (Other)
Overall Status
Recruiting
CT.gov ID
NCT05741138
Collaborator
(none)
40
1
2
3.5
11.3

Study Details

Study Description

Brief Summary

The goal of this Randomized controlled trial is 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 will be a given consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria. 2 groups would be included in study, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises will be carried out in their respective standard positions (can be modified according to patient's comfortability). We will measure outcome through different outcome measure tools.

Condition or Disease Intervention/Treatment Phase
  • Other: Core strengthening
  • Other: Conventional treatment
N/A

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 will be applied on patient with lumbar radiculopathy and calf pain to see whether it helps to reduce pain or not.

Participants will be a given consent form and after subjects read and sign the informed consent, they would be included in study according to eligibility criteria. 2 groups would be included in study, the Standard Physical Therapy treatment along with core strengthening exercises. Core strengthening exercises will be carried out in their respective standard positions (can be modified according to patient's comfortability). We will measure outcome through different outcome measure tools.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Effect of Routine Physical Therapy With and Without Core Stability Exercises in Patients With Lumbar Radiculopathy. A Randomized Controlled Trial
Actual Study Start Date :
Feb 13, 2023
Anticipated Primary Completion Date :
May 1, 2023
Anticipated Study Completion Date :
Jun 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Core strengthening group

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

Other: Core strengthening
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 would be given only Standard Physical Therapy treatment.

Other: Conventional 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)

Outcome Measures

Primary Outcome Measures

  1. Lower extremity functional pain scale (change is being assessed) [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.

  2. Oswestry disability index(change is being assessed) [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

  3. visual analog scale (change is being assessed) [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
40 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Sehat medical Complex Lahore Punjab Pakistan

Sponsors and Collaborators

  • Sehat Medical Complex

Investigators

  • Principal Investigator: Hassan Javaid, University of Lahore

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Waseem Javaid, Project Director, Sehat Medical Complex
ClinicalTrials.gov Identifier:
NCT05741138
Other Study ID Numbers:
  • hassanjavaid19
First Posted:
Feb 23, 2023
Last Update Posted:
Feb 23, 2023
Last Verified:
Feb 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 23, 2023