- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06796478
Tailored Egoscue Exercises in Patients With Lumbar Radiculopathy
Effects of Tailored Egoscue Exercises on Pain, Functional Performance and Sleep Quality in Patients With Lumbar Radiculopathy
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
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Punjab
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Gujrat, Punjab, Pakistan, 50700
- Rayan Medical center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A
10 minutes of heat therapy and 30 minutes of tailored Egoscue excercises
|
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
|
|
Active Comparator: Group B
10 minutes of heat therapy & core stabilization exercises employed for 30 minutes.
|
A. Cat Pose & Camel pose B. Pelvic tilt C. Hip flexor stretches D. Hamstring stretches E. Piriformis stretch F. Prone on elbow
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Numerical Pain Rating Scale (NPRS):
Time Frame: 6weeks
|
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)
Time Frame: 6weeks
|
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
Time Frame: 6weeks
|
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
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Aruba Saeed, Phd*, Riphah International University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- REC/RCR&AHS/24/0213NamraSarwar
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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