NCT06796478

Brief Summary

Lumbar radiculopathy (LR), commonly sciatica, is characterized by inflammation of the lower back's nerve roots. It is typically caused by sensory disruptions that arise from the lumbar spine and extend downward below the knee. LR is marked by alterations in motor and sensory functions, such as Radicular discomfort,functional performance paresthesia, or tingling in the lower limb. This research aims to explore the Effects of Tailored Egoscue Exercises on Pain, Functional Performance and Sleep Quality in Patients with Lumbar Radiculopathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2024

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

September 10, 2024

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 26, 2024

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2025

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

January 22, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
Last Updated

January 28, 2025

Status Verified

January 1, 2025

Enrollment Period

4 months

First QC Date

January 22, 2025

Last Update Submit

January 22, 2025

Conditions

Keywords

egoscue excerciseslumbar radiculopathy

Outcome Measures

Primary Outcomes (3)

  • Numerical Pain Rating Scale (NPRS):

    The NPRS is commonly used for assessing the intensity of pain, requiring patients to indicate their pain severity by choosing a number on a scale ranging from 0 to 10. This implies that a Numeric Rating Scale (NRS) score within the 1-5 range indicates a mild disruption in functioning, scores of 6 and 7 denote moderate interference and a score within the 8-10 range signifies severe interference with functionality. The pain scale spans from zero, indicating no pain, to ten, signifying the utmost agony. Reliable test-retest consistency has been evidenced through NPRS, with correlation coefficients of 0.96 and 0.95, respectively.

    6weeks

  • The Roland Morris Disability Questionnaire (RMDQ)

    It was employed to assess patients' functional limitations. The RMQ, a patient-reported outcome measure consisting of 24 items, assesses disability related to pain arising from lower back pain. Each item is assigned a score of 0 if left unanswered or 1 if affirmed, resulting in a total RMQ score that ranges from 0 to 24. Elevated scores indicate greater levels of pain-related disability. Therefore, a higher numerical value is indicative of more pronounced lumbago severity. Upon examination of the 24 items, it becomes apparent that they encompass a diverse range of aspects. Some items appear linked to the physical facets of quality of life (QOL), while others likely capture different dimensions of QOL. The RMDQ has demonstrated a high level of internal consistency reliability (Cronbach's alpha of 0.87) and test-retest reliability (ICC of 0.9). A change of 2-3 points (8-12%) is considered clinically significant

    6weeks

  • Insomnia Severity Index (ISI) questionnaire

    A self-reported questionnaire called the Insomnia Severity Index (ISI) is used to assess how well people slept over the previous month. The seven-item questionnaire, which is a quick screening tool for insomnia, asks participants to use a Likert-style scale to score the kind and severity of their sleep issues. Questions about subjective aspects of the respondent's sleep include how severe symptoms are, how satisfied the respondent is with their sleep patterns, how much insomnia interferes with day-to-day functioning, how obvious they believe their insomnia is to others, and how much distress the sleep issue causes them overall. Management The short scale is a pencil-and-paper self-report measure that takes only roughly five minutes to complete. It found item-total correlations that were very varied, ranging from 36 to 54, and had an internal consistency of a =.74. Likert-type scales are used by respondents to score each component of the survey.

    6weeks

Study Arms (2)

Group A

EXPERIMENTAL

10 minutes of heat therapy and 30 minutes of tailored Egoscue excercises

Other: Tailored Egoscue Excercises

Group B

ACTIVE COMPARATOR

10 minutes of heat therapy \& core stabilization exercises employed for 30 minutes.

Other: Core stabilization excercises

Interventions

A. Elbow curls on the wall with abduction B. Elbow curls on the wall with adduction C. Overhead extension D. Open Up arm and chest E. Upper spinal twist. F. Spinal Twist G. Pelvic tilts H. Static back alone and static back with breathing I. Static wall. J. Air Bench Abdominal contraction in the static back position. K. Resisted Abduction L. Abductor press M. Supine groin progression

Group A

A. Cat Pose \& Camel pose B. Pelvic tilt C. Hip flexor stretches D. Hamstring stretches E. Piriformis stretch F. Prone on elbow

Group B

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 45-65 years
  • Both male and female
  • Lumbar disc herniation /lumbar radiculopathy secondary to L4/L5 and L5/S1
  • Patients diagnosed with lumbar radiculopathy by neuro physician
  • Positive Lasègue's test(SLRT): Positive if pain occurs when the hip is flexed at 30 and 60 or 70 degrees from horizontal.
  • Positive Bragrd's sign: Applying ankle dorsiflexion after the straight leg raise (SLR) with the knee extended causes pain.
  • Positive Slump test: positive if symptoms are increased in the slumped position and decreased as the patient moves out of neck flexion

You may not qualify if:

  • Received treatment for LBP in the past 6 months
  • Practiced any kind of exercise or sports activity during the last 6 months
  • spinal tumors
  • infections
  • pregnancy
  • neoplasm

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rayan Medical center

Gujrat, Punjab Province, 50700, Pakistan

Location

MeSH Terms

Conditions

Radiculopathy

Condition Hierarchy (Ancestors)

Peripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Study Officials

  • Aruba Saeed, PhD*

    Riphah International University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2025

First Posted

January 28, 2025

Study Start

September 10, 2024

Primary Completion

December 26, 2024

Study Completion

January 10, 2025

Last Updated

January 28, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations