Lumbosacral RadiculopathyNCT05654428
Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-sarcal Radiculopathy
A study testing Mckenzie Extension Exercises and William Flexion Exercises in people with Lumbosacral Radiculopathy, run by Neuro Counsel Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Lumbosacral Radiculopathy
- What is being tested?
- Mckenzie Extension Exercises and William Flexion Exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 sitePakistan
- Study dates
- 22 Sep 2022to 1 Feb 2023
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • Males and females with age between 40-60 years
- Patients referred from neuro and orthopedic departments with diagnosed lumbosacral radiculopathy.
- Complaint of low back pain on walk, bending and after long sitting with positive slump test.
- Complaint of low back pain, and numbness and tingling in leg with positive SLR test
Who cannot join
- • Lumbar Trauma
- Any other orthopedic and neurological conditions of hip and lumbosacral spine.
- Hip Fracture
- Malignancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-Sarcal Radiculopathy
Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.
Read the detailed description
- William flexion exercises: Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).
- Mckenzie extension exercises: The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone
A randomized controlled trial.
Group 1 Group 2 55 patients 55 patients
Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes
New Intervention:
Mckenzie Extension
- Prone press-ups
- Head life in prone
- Prone on elbow
- Prone on hands
- Prone on pillow New Intervention:
William Flexion
- Single knee to chest
- Double knee to chest
- Straight Leg Raise
- Bridging
- Pelvic tilt
Each exercise will be repeated 5 minutes with 10 seconds hold and 5 sec rest. The duration of intervention will be four weeks, 3 sessions a week on alternate days and total of 12 sessions will be given. Data will be collected in three phases Pre-Treatment at end of second week and at the completion of treatment time i.e end of 4th week.
- Conditions
- Lumbosacral Radiculopathy
- Being tested
- Mckenzie Extension Exercises, William Flexion Exercises
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mckenzie Extension ExercisesOther
The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone.
William Flexion ExercisesOther
Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 55 patients
Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes
New Intervention:
Mckenzie Extension
* Prone press-ups
* Head life in prone
* Prone on elbow
* Prone on hands
* Prone on pillow Receives: Other: Mckenzie Extension Exercises |
| Control Group | Active comparator | 55 patients
Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes
New Intervention:
William Flexion
* Single knee to chest
* Double knee to chest
* Straight Leg Raise
* Bridging
* Pelvic tilt Receives: Other: William Flexion Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Pain Rating Scale
0 means no pain and 10 means worst pain ever felt
Measured: 4 weeks
Flexi curve ruler
to measure the lumber cure
Measured: 4 weeks
Bubble inclinometer
Measure the cure
Measured: 4 weeks
King Health Questionnaire quality of life
lesser score means low quality of life and higher score means better quality of life
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start22 Sep 2022
- Primary completion21 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbosacral RadiculopathyStudies of the same condition, open and under way.
- 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
- Model description
- A Randomized Control Trail with 2 Equal groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Neuro Counsel Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Rehabilitation Medicine, Islamabad, Pakistan
- Responsible party
- Principal investigator, Muhammad salman, PT, Isra University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05654428
- Sponsor's protocol ID
- 337
- Status last verified
- Feb 2023
- First submitted
- 7 Dec 2022
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mackenzie Extension and William Flexion Exercises in Lumbo-Sarcal Radiculopathy
- ClinicalTrials.gov ID
- NCT05654428
- Acronym / sponsor ID
- 337
- Conditions
- Lumbosacral Radiculopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Neuro Counsel Hospital, PakistanUniversity, hospital or other
- Collaborators
- National Institute of Rehabilitation Medicine, Islamabad, Pakistan
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 21 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 16 Dec 2022 (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.
Lumbosacral radiculopathy (LR) is among most common disorder caused due to irritation or compression of nerve pathway leading to symptoms of pain, numbness and tingling sensations along the nerve root. Lumbosacral radiculopathy consists at any lumbar region including L1-S1. Occurrence rate of Lumbosacral radiculopathy is 3-5% distributed equally in men and women affecting more men than women. It commonly occurs in late 40s in men and late 50s-60s in females. Men are more prone to develop lumbosacral radiculopathy due to mechanical disturbance during routine work.
Detailed description
- William flexion exercises: Exercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR).
- Mckenzie extension exercises: The exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone
A randomized controlled trial.
Group 1 Group 2 55 patients 55 patients
Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes Standard treatment:
TENS (4-pole) + Hot pack for 15 minutes
New Intervention:
Mckenzie Extension
- Prone press-ups
- Head life in prone
- Prone on elbow
- Prone on hands
- Prone on pillow New Intervention:
William Flexion
- Single knee to chest
- Double knee to chest
- Straight Leg Raise
- Bridging
- Pelvic tilt
Each exercise will be repeated 5 minutes with 10 seconds hold and 5 sec rest. The duration of intervention will be four weeks, 3 sessions a week on alternate days and total of 12 sessions will be given. Data will be collected in three phases Pre-Treatment at end of second week and at the completion of treatment time i.e end of 4th week.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A Randomized Control Trail with 2 Equal groups
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: Mckenzie Extension Exercises55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: Mckenzie Extension * Prone press-ups * Head life in prone * Prone on elbow * Prone on hands * Prone on pillow |
| Control Group | Active comparator | Other: William Flexion Exercises55 patients Standard treatment: TENS (4-pole) + Hot pack for 15 minutes Standard treatment: TENS (4-pole) + Hot pack for 15 minutes New Intervention: William Flexion * Single knee to chest * Double knee to chest * Straight Leg Raise * Bridging * Pelvic tilt |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • Males and females with age between 40-60 years
Key exclusion criteria (4 listed)
- • Lumbar Trauma
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 |
|---|---|---|
| Mckenzie Extension ExercisesThe exercises used to create space between under lying structures of lumber spine which help centralization of pain and can be performed in prone lying such as prone press ups, prone on elbow, and head lift in prone. | Other | Experimental Group |
| William Flexion ExercisesExercises for strengthening of gluteal and abdominal muscles which help to reduce pressure on the nerve root by promoting flexion at lumber spine such as knee to chest, double knee to chest, bridging(Gluets bridge), and straight leg raise (SLR). | Other | Control Group |
Primary outcome
Numeric Pain Rating Scale
Time frame: 4 weeks
0 means no pain and 10 means worst pain ever felt
Flexi curve ruler
Time frame: 4 weeks
to measure the lumber cure
Bubble inclinometer
Time frame: 4 weeks
Measure the cure
King Health Questionnaire quality of life
Time frame: 4 weeks
lesser score means low quality of life and higher score means better quality of life
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 2 Feb 2023.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mckenzie Extension Exercises and William Flexion Exercises in people with Lumbosacral Radiculopathy, run by Neuro Counsel Hospital, Pakistan 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 4 inclusion and 4 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 2 Feb 2023. 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?
Numeric Pain Rating Scale (time frame: 4 weeks). The study lists 4 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 2 Feb 2023.