NCT05741138

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2023

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

February 14, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 23, 2023

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 28, 2023

Completed
19 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2023

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

6 months

First QC Date

February 14, 2023

Last Update Submit

August 31, 2023

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (2)

Core strengthening group

EXPERIMENTAL

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

Conventional treatment group

SHAM COMPARATOR

Group B were given only Standard Physical Therapy treatment.

Other: Conventional treatment

Interventions

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.

Core strengthening group

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)

Conventional treatment group

Eligibility Criteria

Age40 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years
  • Both genders
  • Low back pain radiating towards calf for more than 2 months (diagnosed by the orthopedic surgeon)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sehat medical Complex

Lahore, Punjab Province, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Hassan Javaid

    University of Lahore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Project Director

Study Record Dates

First Submitted

February 14, 2023

First Posted

February 23, 2023

Study Start

February 4, 2023

Primary Completion

July 28, 2023

Study Completion

August 16, 2023

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations