Lumbar Disc HerniationNCT05659342
Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation
A study testing ELDOA Technique and Mechanical Lumbar Traction in people with Lumbar Disc Herniation, run by Riphah International University at 1 site in Pakistan.
Trial summary
To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation. To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Lumbar Disc Herniation
- What is being tested?
- ELDOA Technique and Mechanical Lumbar Traction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 5 Mar 2020to 4 Jan 2021
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 20-65 years
- Both gender Male \& Female
- Patients having Lumbar radiculopathy diagnosed with lumbar disc herniation.
Who cannot join
- Patients presented with motor deficit,
- Qauda equina syndrome,
- lumbar fracture
- spinal stenosis,
- osteophyte formation
- facet joint pathology
Show all 10Show fewer
- spondylolisthesis.
- malignancy,
- degenerative disorders
- recent back surgery and patient whom surgery for lumbar disc herniation/prolapse intervertebral disc already advised by neurosurgeon
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lady Reading Hospital - Medical Teaching Institution
Peshawar, Khyber Pakhtunkhwa, 25000
About this study
To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation.
To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation.
- Conditions
- Lumbar Disc Herniation
- Being tested
- ELDOA Technique, Mechanical Lumbar Traction
- Medical subject headings
- Intervertebral Disc Displacement
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELDOA TechniqueOther
the patients treated with ELDOA technique, followed for 3 alternative days for 4 weeks.
the ELDOA techniques for level L4/L5 and L5/S1 were applied. the ELDOA positions hold for one minute, 3 alternative days for 4 weeks under supervision.
Hot pack (10-15 minutes) McKenzie Extension Exercises
Mechanical Lumbar TractionOther
Mechanical Traction Technique: traction unit, 50% of body weight was applied with the patients lying in supine position, with the hip and knee at 90 degree flexion, and legs were supported. Traction were applied for 3 alternative days for 4 weeks.
Hot pack (10-15 minutes) McKenzie Extension Exercises
| Study group | Role | What they receive |
|---|---|---|
| ELDOA Technique | Experimental | ELDOA positions (hold for 1 minute, 3 alternative days for 4 weeks). Hot pack (10-15 minutes) McKenzie extension Exercises Receives: Other: ELDOA Technique |
| Mechanical Lumbar Traction | Experimental | Mechanical Lumbar Traction (50% of body weight was applied, in supine position, the hip and knee at 90- degree flexion, and the legs were supported.
Hot pack (10-15 minutes) McKenzie extension Exercises Receives: Other: Mechanical Lumbar Traction |
What is being measured
The primary outcome is the main question the study is designed to answer.
lumbar ROM by inclinometer.
Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25
Measured: 4 weeks
pain on Numeric pain rating scale
Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain
Measured: 4 Weeks
Modified Oswestry low back pain disability questionnaire
0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%:These patients are either bed-bound or exaggerating their symptoms
Measured: 4th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start5 Mar 2020
- Primary completion4 Jan 2021
- Study completion4 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Disc HerniationStudies 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
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Asghar Khan, DCS-PT, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05659342
- Sponsor's protocol ID
- Abid ullah
- Status last verified
- Jan 2023
- First submitted
- 13 Dec 2022
- Last updated
- 1 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 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of ELDOA and Mechanical Traction Technique on Pain and Disability in Patients With Lumbar Disc Herniation
- ClinicalTrials.gov ID
- NCT05659342
- Acronym / sponsor ID
- Abid ullah
- Conditions
- Lumbar Disc Herniation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 5 Mar 2020 (actual)
- Primary completion
- 4 Jan 2021 (actual)
- Study completion
- 4 Jan 2021 (actual)
- First posted
- 21 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.
To compare the effect of ELDOA and Mechanical traction technique on pain in patients with lumbar disc herniation.
To compare the effect of ELDOA and Mechanical traction technique on disability in patients with lumbar disc herniation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ELDOA Technique | Experimental | Other: ELDOA TechniqueELDOA positions (hold for 1 minute, 3 alternative days for 4 weeks). Hot pack (10-15 minutes) McKenzie extension Exercises |
| Mechanical Lumbar Traction | Experimental | Other: Mechanical Lumbar TractionMechanical Lumbar Traction (50% of body weight was applied, in supine position, the hip and knee at 90- degree flexion, and the legs were supported. Hot pack (10-15 minutes) McKenzie extension Exercises |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 20-65 years
- Both gender Male \& Female
- Patients having Lumbar radiculopathy diagnosed with lumbar disc herniation.
Key exclusion criteria (10 listed)
- Patients presented with motor deficit,
- Qauda equina syndrome,
- lumbar fracture
- spinal stenosis,
- osteophyte formation
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 |
|---|---|---|
| ELDOA Techniquethe patients treated with ELDOA technique, followed for 3 alternative days for 4 weeks. the ELDOA techniques for level L4/L5 and L5/S1 were applied. the ELDOA positions hold for one minute, 3 alternative days for 4 weeks under supervision. Hot pack (10-15 minutes) McKenzie Extension Exercises | Other | ELDOA Technique |
| Mechanical Lumbar TractionMechanical Traction Technique: traction unit, 50% of body weight was applied with the patients lying in supine position, with the hip and knee at 90 degree flexion, and legs were supported. Traction were applied for 3 alternative days for 4 weeks. Hot pack (10-15 minutes) McKenzie Extension Exercises | Other | Mechanical Lumbar Traction |
Primary outcome
lumbar ROM by inclinometer.
Time frame: 4 weeks
Flexion 60 Extension 25 Left Lat Flex 25 Right Lat Flex 25
pain on Numeric pain rating scale
Time frame: 4 Weeks
Changes from baseline, Pain was measured through Numeric pain rating scale.It comprises of a continuous scale of 10cm line.0 to 1 represent no pain, 1 to 3 represent mild pain ,4 to 6 represent moderate pain, 7 to 10 represent severe pain
Modified Oswestry low back pain disability questionnaire
Time frame: 4th Week
0% to 20%: minimal disability: The patient can cope with most living activities. Usually no treatment is indicated apart from advice on lifting sitting and exercise. 21%-40%: moderate disability: The patient experiences more pain and difficulty with sitting, lifting and standing. Travel and social life are more difficult and they may be disabled from work. Personal care, sexual activity and sleeping are not grossly affected and the patient can usually be managed by conservative means. 41%-60%: severe disability: Pain remains the main problem in this group but activities of daily living are affected. These patients require a detailed investigation. 61%-80%: crippled: Back pain impinges on all aspects of the patient's life. Positive intervention is required. 81%-100%:These patients are either bed-bound or exaggerating their symptoms
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 1 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.
Asghar Khan, DCS-PT study chair
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 ELDOA Technique and Mechanical Lumbar Traction in people with Lumbar Disc Herniation, 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 3 inclusion and 10 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 1 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?
lumbar ROM by inclinometer. (time frame: 4 weeks). 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 1 Feb 2023.