Lumbar RadiculopathyNCT06796478
Tailored Egoscue Exercises in Patients With Lumbar Radiculopathy
A study testing Tailored Egoscue Excercises and Core stabilization excercises in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Lumbar Radiculopathy
- What is being tested?
- Tailored Egoscue Excercises and Core stabilization excercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 sitePakistan
- Study dates
- 10 Sep 2024to 10 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the detailed description
The study was a randomized controlled trial, total 54 patients were recruited from Rayan Medical Center, Gujrat by using probability convenience sampling technique and assigned into two equal groups .27 patients in Group A (Experimental group) did Egoscue exercises while Group B (Control group) was provided with routine rehabilitation. In this study, age group between 45 to 65 pre-diagnosed with lumbar radiculopathy by a neurophysician was included. Lasègue's test , Bragard's test and Slump test was performed as a screening tool in the study. Exercises was performed for 40 minutes per day on 3 alternate days per week for 6 weeks.Group A (Experimental Group) included 10 minutes of heat therapy and 30 minutes of Egoscue training while at Group B (Control Group) 10 minutes of heat therapy, gentle stretches \& core stabilization exercises for 30 minutes was performed. Patients was assessed at three levels pre (at baseline), mid (after 3 weeks) and post level(after 6 weeks) . Assessment tool was a Numerical pain rating Scale, Rolland-Morris Disability Questionnaire \& Insomnia Severity Index (ISI) to assess the outcome variable
- Conditions
- Lumbar Radiculopathy
- Being tested
- Tailored Egoscue Excercises, Core stabilization excercises
- Keywords
- egoscue excercises, lumbar radiculopathy
- Medical subject headings
- Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Egoscue ExcercisesOther
- 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
Core stabilization excercisesOther
- Cat Pose \& Camel pose B. Pelvic tilt C. Hip flexor stretches D. Hamstring stretches E. Piriformis stretch F. Prone on elbow
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | 10 minutes of heat therapy and 30 minutes of tailored Egoscue excercises Receives: Other: Tailored Egoscue Excercises |
| Group B | Active comparator | 10 minutes of heat therapy \& core stabilization exercises employed for 30 minutes. Receives: Other: Core stabilization excercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: 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.
Measured: 6weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start10 Sep 2024
- Primary completion26 Dec 2024
- Study completion10 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar RadiculopathyStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Aruba Saeed, PhD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06796478
- Sponsor's protocol ID
- REC/RCR&AHS/24/0213NamraSarwar
- Status last verified
- Jan 2025
- First submitted
- 22 Jan 2025
- Last updated
- 28 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Tailored Egoscue Exercises on Pain, Functional Performance and Sleep Quality in Patients With Lumbar Radiculopathy
- ClinicalTrials.gov ID
- NCT06796478
- Acronym / sponsor ID
- REC/RCR&AHS/24/0213NamraSarwar
- Conditions
- Lumbar Radiculopathy
- Keywords
- egoscue excercises, lumbar radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 10 Sep 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 28 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
The study was a randomized controlled trial, total 54 patients were recruited from Rayan Medical Center, Gujrat by using probability convenience sampling technique and assigned into two equal groups .27 patients in Group A (Experimental group) did Egoscue exercises while Group B (Control group) was provided with routine rehabilitation. In this study, age group between 45 to 65 pre-diagnosed with lumbar radiculopathy by a neurophysician was included. Lasègue's test , Bragard's test and Slump test was performed as a screening tool in the study. Exercises was performed for 40 minutes per day on 3 alternate days per week for 6 weeks.Group A (Experimental Group) included 10 minutes of heat therapy and 30 minutes of Egoscue training while at Group B (Control Group) 10 minutes of heat therapy, gentle stretches \& core stabilization exercises for 30 minutes was performed. Patients was assessed at three levels pre (at baseline), mid (after 3 weeks) and post level(after 6 weeks) . Assessment tool was a Numerical pain rating Scale, Rolland-Morris Disability Questionnaire \& Insomnia Severity Index (ISI) to assess the outcome variable
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Tailored Egoscue Excercises10 minutes of heat therapy and 30 minutes of tailored Egoscue excercises |
| Group B | Active comparator | Other: Core stabilization excercises10 minutes of heat therapy \& core stabilization exercises employed for 30 minutes. |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Egoscue ExcercisesA. 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 | Other | Group A |
| Core stabilization excercisesA. Cat Pose \& Camel pose B. Pelvic tilt C. Hip flexor stretches D. Hamstring stretches E. Piriformis stretch F. Prone on elbow | Other | Group B |
Primary outcome
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.
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2025.
- Individual participant dataSharing planned: No
Related trials for Lumbar Radiculopathy
Active, not recruiting
Comparative Effects of Kinetic Control Training and Neural Mobilization in Lumbar Radiculopathy
Lumbar Radiculopathy
Recruiting
Effect of Transfer of Energy Capacitive and Resistive on Chronic Discogenic Sciatica
Lumbar Radiculopathy
Not yet recruiting
Selective Nerve Root Block Versus Sham to Reduce Surgery for Lumbar Disc Herniation
Lumbar Disc Herniation, Lumbar Radiculopathy
Recruiting
Comparative Effect Between Mulligan Leg Raise and Spinal Mobilization With Limb Movement in Lumbar Radiculopathy
Lumbar Radiculopathy
Not yet recruiting
Comparison of Efficacy of Caudal Versus Transforaminal Epidural Steroid Injections in Unilateral S1 Nerve Root Pain: A Randomized Controlled Trial
Unilateral S1 Nerve Root Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aruba Saeed, PhD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Egoscue Excercises and Core stabilization excercises in people with Lumbar Radiculopathy, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numerical Pain Rating Scale (NPRS): (time frame: 6weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2025.