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

Lumbar Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05741138
• Other study ID #: hassanjavaid19
• Status: Completed
• Phase: N/A
• Start date: February 4, 2023
• Est. completion date: August 16, 2023

Study information

• Verified date: August 2023
• Source: Sehat Medical Complex
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 16, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Lumbar Radiculopathy
• Radiculopathy

Intervention

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.
• 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)

Locations

Country	Name	City	State
Pakistan	Sehat medical Complex	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Sehat Medical Complex

Country where clinical trial is conducted

Pakistan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline after 12 weeks
Primary	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	Change from baseline after 12 weeks
Primary	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.	Change from baseline after 12 weeks