Disk Herniated LumbarNCT05261815
Compare Effects of Ultrasound Therapy With High Intensity Laser Therapy for Treatment of Lumbar Disc Herniation.
A study testing Ultrasound Therapy and High Intensity Laser Therapy in people with Disk Herniated Lumbar, run by Riphah International University at 1 site in Pakistan.
Trial summary
The aim of this study is to assess and compare the effects of ultrasound therapy and High Intensity Laser Therapy, as the treatment option in case of lumbar disc herniation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Disk Herniated Lumbar
- What is being tested?
- Ultrasound Therapy and High Intensity Laser Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2021to 31 Mar 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient above age 18 and adult
- Patient with lumbar disc herniation diagnosed by MRI
- Patient with no history of trauma and congenital abnormalities
Who cannot join
- If patient received anesthesia or corticosteroid within 4 week
- Patient with osteoporosis
- Patient with surgery or previous fracture of spinal stenosis
- A history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome.
- Pregnant women
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Ripah International University
Faisalabad, Punjab Province, 38000
About this study
Official title: Comparative Effectivness Between Ultrasound Therapy And High Intensity Laser Therapy In The Treatment Of Lumbar Disc Herniation.
The aim of this study is to assess and compare the effects of ultrasound therapy and High Intensity Laser Therapy, as the treatment option in case of lumbar disc herniation.
Read the detailed description
A randomized control trail will be conducted in Safi teaching hospital near Riphah international university, after approval of synopsis. To evaluate the comparison and effect of Ultrasound therapy and High Intensity Laser Therapy, 30 patients will be randomly assigned to High Intensity Laser Therapy and Ultrasound group. Patients will be selected according to predefined inclusion and exclusion criteria. All the patients will be evaluated by computed tomography scan or magnetic resonance of lumbar spine. Non-probability convenient sampling will be used to approach the patients in hospital. Participants received 15 treatment session of High Intensity Laser Therapy and Ultrasound therapy over a period of three consecutive weeks (five days/week). Two types of tools will be used to evaluate the find out the comparison of both groups Visual analog scale and Oswestry lowback pain disability questionnaire. Data will be collected pre-treatment and post-treatment after 15 days. Data will be analyzed by Statistical Package of Social Sciences Version 20. Difference between pre-treatment to post treatment between group will be analyzed by Mann-Whitney test, and Within group difference will be analyzed by Wilcoxon signed- rank test. The level of statistical significance will be set as p< 0.05
- Conditions
- Disk Herniated Lumbar
- Being tested
- Ultrasound Therapy, High Intensity Laser Therapy
- Keywords
- High Intensity Laser Therapy, Ultrasound Therapy, Lumbar, Disc Herniation., Randomized Control Trial, Comparison
- 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.
Ultrasound TherapyOther
Ultrasound Therapy improves the pain management in patients with herniation. It eases down the severity of symptoms as well.
High Intensity Laser TherapyOther
Treatment of low disc herniation should be non-surgical, pharmacological and by physical therapy modalities. Laser radiation with high intensity used as a modality called high intensity laser therapy. It is used to relieve the pain by three process; Photo-chemical, Photo-thermal, Photo-mechanical. High Intensity Laser Therapy uses high intensity laser irradiation and low light absorption.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound therapy | Experimental | * Continuous ultrasound therapy for 15 minutes
* Traction for 30 minutes
* Spinal decompression exercises for 20 min Receives: Other: Ultrasound Therapy |
| High Intensity Laser Therapy | Experimental | * High intensity laser for 10 minutes
* Traction for 30 minutes
* Spinal decompression exercises for 20 min Receives: Other: High Intensity Laser Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Measured: 12th Week
Oswestry low back pain questionnaire
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
Measured: 12th Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2022
- Study start1 Mar 2021
- Primary completion25 Mar 2022
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disk Herniated LumbarStudies 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Muhammad Kashif, Study chair, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05261815
- Sponsor's protocol ID
- REC-FSD-00244
- Status last verified
- Jun 2022
- First submitted
- 20 Feb 2022
- Last updated
- 22 Jun 2022
- 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 22 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectivness Between Ultrasound Therapy And High Intensity Laser Therapy In The Treatment Of Lumbar Disc Herniation.
- ClinicalTrials.gov ID
- NCT05261815
- Acronym / sponsor ID
- REC-FSD-00244
- Conditions
- Disk Herniated Lumbar
- Keywords
- High Intensity Laser Therapy, Ultrasound Therapy, Lumbar, Disc Herniation., Randomized Control Trial, Comparison
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 1 Mar 2021 (actual)
- Primary completion
- 25 Mar 2022 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 2 Mar 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.
The aim of this study is to assess and compare the effects of ultrasound therapy and High Intensity Laser Therapy, as the treatment option in case of lumbar disc herniation.
Detailed description
A randomized control trail will be conducted in Safi teaching hospital near Riphah international university, after approval of synopsis. To evaluate the comparison and effect of Ultrasound therapy and High Intensity Laser Therapy, 30 patients will be randomly assigned to High Intensity Laser Therapy and Ultrasound group. Patients will be selected according to predefined inclusion and exclusion criteria. All the patients will be evaluated by computed tomography scan or magnetic resonance of lumbar spine. Non-probability convenient sampling will be used to approach the patients in hospital. Participants received 15 treatment session of High Intensity Laser Therapy and Ultrasound therapy over a period of three consecutive weeks (five days/week). Two types of tools will be used to evaluate the find out the comparison of both groups Visual analog scale and Oswestry lowback pain disability questionnaire. Data will be collected pre-treatment and post-treatment after 15 days. Data will be analyzed by Statistical Package of Social Sciences Version 20. Difference between pre-treatment to post treatment between group will be analyzed by Mann-Whitney test, and Within group difference will be analyzed by Wilcoxon signed- rank test. The level of statistical significance will be set as p< 0.05
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ultrasound therapy | Experimental | Other: Ultrasound Therapy* Continuous ultrasound therapy for 15 minutes * Traction for 30 minutes * Spinal decompression exercises for 20 min |
| High Intensity Laser Therapy | Experimental | Other: High Intensity Laser Therapy* High intensity laser for 10 minutes * Traction for 30 minutes * Spinal decompression exercises for 20 min |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient above age 18 and adult
- Patient with lumbar disc herniation diagnosed by MRI
- Patient with no history of trauma and congenital abnormalities
Key exclusion criteria (5 listed)
- If patient received anesthesia or corticosteroid within 4 week
- Patient with osteoporosis
- Patient with surgery or previous fracture of spinal stenosis
- A history of acute trauma like osteoarthritis, myofascial pain syndrome, inflammatory rheumatic disease, systemic lupus erythematosus, diabetes mellitus type 1 and 2, thyroid dysfunction, obesity, pacemaker, neurological pathologies and anxious- depressive syndrome.
- Pregnant women
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 |
|---|---|---|
| Ultrasound TherapyUltrasound Therapy improves the pain management in patients with herniation. It eases down the severity of symptoms as well. | Other | Ultrasound therapy |
| High Intensity Laser TherapyTreatment of low disc herniation should be non-surgical, pharmacological and by physical therapy modalities. Laser radiation with high intensity used as a modality called high intensity laser therapy. It is used to relieve the pain by three process; Photo-chemical, Photo-thermal, Photo-mechanical. High Intensity Laser Therapy uses high intensity laser irradiation and low light absorption. | Other | High Intensity Laser Therapy |
Primary outcome
Visual Analogue Scale
Time frame: 12th Week
A Visual Analogue Scale is a measurement instrument that tries to measure a characteristic or attitude that is believed to range across a continuum of values and cannot easily be directly measured. It is often used in epidemiologic and clinical research to measure the intensity or frequency of various symptoms.
Oswestry low back pain questionnaire
Time frame: 12th Week
The Oswestry Low Back Pain Disability Questionnaire is an extremely important tool that researchers and disability evaluators use to measure a patient's permanent functional disability. The test is considered the 'gold standard' of low back functional outcome tools
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 22 Jun 2022.
- 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.
Muhammad Kashif 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 Ultrasound Therapy and High Intensity Laser Therapy in people with Disk Herniated Lumbar, 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 5 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 22 Jun 2022. 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?
Visual Analogue Scale (time frame: 12th Week). The study lists 2 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 22 Jun 2022.