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CompletedNCT05741138Updated Sep 5, 2023

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

An interventional study of Core strengthening and Conventional treatment in Lumbar Radiculopathy, sponsored by Sehat Medical Complex. Completed at 1 site in Pakistan. Open to participants aged 40 Years to 65 Years. Per ClinicalTrials.gov, last updated 2023-09-05.

Sponsored by Sehat Medical Complex · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
76
Allocation
Randomized
Ages
40 Years to 65 Years
Sex
All
01

Study 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.
Read the 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.

02

Conditions studied

  • Lumbar Radiculopathy

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03

In context

Radiculopathy

488 studies on the registry are indexed under Radiculopathy; 141 are open to participants now.

This study's enrollment of 76 is above the median of 60 across 376 interventional studies indexed under Radiculopathy.

Browse Radiculopathy studies →

Lead sponsor

Sehat Medical Complex is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 65 Years
Sexes eligible
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

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
76 participants (actual)

Study arms

  • 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)

    Other: Core strengthening

  • Sham comparator
    Conventional treatment group

    Group B were given only Standard Physical Therapy treatment.

    Other: Conventional treatment

Interventions

  • OtherCore 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.

  • OtherConventional 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)

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Change from baseline after 12 weeks

  2. 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

    Time frame: Change from baseline after 12 weeks

  3. 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.

    Time frame: Change from baseline after 12 weeks

07

Study locations

1 site
  • Sehat medical Complex
    Lahore, Punjab, Pakistan
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 5, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT05741138
Lead sponsor
Sehat Medical Complex
Responsible party
Waseem Javaid (Project Director, Sehat Medical Complex) — Principal investigator
First posted
Feb 23, 2023
Start date
Feb 4, 2023
Primary completion
Jul 28, 2023
Completion
Aug 16, 2023
Last update
Sep 5, 2023

Study contacts

Hassan Javaid
principal investigator · University of Lahore

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.

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