SpondylolysisNCT04814979
Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis
A study testing Low-intensity pulsed ultrasound (LIPUS) and Routine physical therapy in people with Spondylolysis, run by University of Lahore at 1 site in Pakistan.
Trial summary
Low-intensity pulsed ultrasound (LIPUS) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently… Read more about this study
- Who is it for?
- Ages 20 to 40 years
- Conditions the study is for
- Spondylolysis
- What is being tested?
- Low-intensity pulsed ultrasound (LIPUS) and Routine physical therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jun 2020to 15 Mar 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 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both gender
- Diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months
- Age: 20-40 years
Who cannot join
- Subjects with the history of neurological or autonomic deficits,
- Other fracture or bony abnormalities
- Rheumatic disease
- Other spinal problems
- Post-menopausal female
- Osteoporosis
- Osteopenia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Institutional Review Board of Faculty of Allied Health Sciences, University of Lahore
Lahore, Punjab Province, 74000
About this study
Official title: Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis: A Randomized Controlled Trial
Low-intensity pulsed ultrasound (LIPUS) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently their independence.
Read the detailed description
Aim of this study was to determine the effects of low-intensity pulsed ultrasound on pain and functional disability in patients with lumbar spondylolysis. Thirty four (29 males \& 5 females) diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months aged between twenty to forty years were recruited. This randomized controlled trial was a part of PhD Physical Therapy project conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore, Pakistan, from June 2020 to March 2021 by using non probability purposive sampling technique. Subjects were divided randomly into two equal groups (Group-A and Group-B). Lottery method was used to randomly assign patients into two groups. Numeric Pain Rating Scale (NPRS) was utilized to measure pain intensity and Oswestry Disability Index (ODI) to measure functional disability. Data was analyzed by using SPSS 21.
- Conditions
- Spondylolysis
- Being tested
- Low-intensity pulsed ultrasound (LIPUS), Routine physical therapy
- Keywords
- lumbar vertebra, pain, functional disability, low-intensity pulsed ultrasound
- Medical subject headings
- Spondylolysis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-intensity pulsed ultrasound (LIPUS)Device
Low-intensity pulsed ultrasound (LIPUS) consists of frequencies usually ranging from 0.75- 1.5 MHz at intensities <100mW/cm² (usually about 30mW/cm²) and usually pulsed at 1:4. The transducer head is strapped or otherwise held in place and remains stationary for treatment periods in the region of 20 minutes. Again, US medium is used for efficient sound transfer to deeper tissues. This modality was approved by the FDA in the United States in 1994 for the accelerated healing of fresh fractures and then approved by the same body in 2000 for the treatment of established non-union fractures. The studies presented to the FDA demonstrated that LIPUS had a positive effect during all three main stages of fracture healing, i.e. inflammatory, reparative and remodelling by enhancing angiogenesis, chondrogenesis and osteogenesis.
Routine physical therapyOther
Gentle hamstrings stretching for 15 seconds 3 times a day. Flexibility of these muscle reduces stress to the lumbar region thus enhances the spino-pelvic rhythm (lumbar motion/pelvic motion). Strengthening of abdominal muscles (transversus abdominis and internal oblique). Training of these "stability" muscles in the lumbar spine provides a solid foundation for the individuals to integrate them into their functional movement patterns. Exercises focusing on these muscles have been shown to significantly decrease pain and disability in people with spondylolysis. Each exercise will be performed as 3 sets of 10 repetitions on alternate days.
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | Low-intensity pulsed ultrasound along with routine physical therapy Receives: Device: Low-intensity pulsed ultrasound (LIPUS); Other: Routine physical therapy |
| Control Group | Active comparator | Routine physical therapy alone Receives: Other: Routine physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Pain on Numeric Pain Rating Scale at week 12
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain with a reliability of 0.96 and validity 0.86. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Change = (Week 12 Score - Baseline Score)
Measured: Baseline and Week 12
Change from Baseline in the Functional Disability on Oswestry Disability Index at week 12
The Oswestry Disability Index 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 with a reliability of 0.90 and validity 0.96. Scoring Instructions: For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows:
Example: 16 (total scored) 50 (total possible score) x 100 = 32%
If one section is missed or not applicable the score is calculated:
16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement) Change = (Week 12 Score - Baseline Score)
Measured: Baseline and Week 12
Secondary outcomes (2)
Change from Baseline in Pain on Numeric Pain Rating Scale at week 20
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain with a reliability of 0.96 and validity 0.86. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain.
Change = (Week 20 Score - Baseline Score)
Measured: Baseline and Week 20
Change from Baseline in the Functional Disability on Oswestry Disability Index at and week 20
The Oswestry Disability Index 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 with a reliability of 0.90 and validity 0.96. Scoring Instructions: For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows:
Example: 16 (total scored) 50 (total possible score) x 100 = 32%
If one section is missed or not applicable the score is calculated:
16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement) Change = (Week 20 Score - Baseline Score)
Measured: Baseline and Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2021
- Study start15 Jun 2020
- Primary completion15 Mar 2021
- Study completion15 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondylolysisStudies of the same condition, open and under way.
- More trials run by University of LahoreThe 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
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lahore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Fahad Tanveer, PhD, Principal investigator, University of Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04814979
- Sponsor's protocol ID
- IRB-UOL-FAHS-UIPT/690/2020
- Status last verified
- Mar 2021
- First submitted
- 20 Mar 2021
- Last updated
- 29 Mar 2021
- 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 29 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04814979
- Acronym / sponsor ID
- IRB-UOL-FAHS-UIPT/690/2020
- Conditions
- Spondylolysis
- Keywords
- lumbar vertebra, pain, functional disability, low-intensity pulsed ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- University of LahoreUniversity, hospital or other
- Study start
- 15 Jun 2020 (actual)
- Primary completion
- 15 Mar 2021 (actual)
- Study completion
- 15 Mar 2021 (actual)
- First posted
- 24 Mar 2021 (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.
Low-intensity pulsed ultrasound (LIPUS) is effective in accelerating the healing of fractures, reduction in costs to the state, reduction in the numbers of those patients who progress from out-patient care to long term care who, in the process lose their ability to perform activities of daily living and consequently their independence.
Detailed description
Aim of this study was to determine the effects of low-intensity pulsed ultrasound on pain and functional disability in patients with lumbar spondylolysis. Thirty four (29 males \& 5 females) diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months aged between twenty to forty years were recruited. This randomized controlled trial was a part of PhD Physical Therapy project conducted at Department of Physiotherapy, University of Lahore Teaching Hospital, Lahore, Pakistan, from June 2020 to March 2021 by using non probability purposive sampling technique. Subjects were divided randomly into two equal groups (Group-A and Group-B). Lottery method was used to randomly assign patients into two groups. Numeric Pain Rating Scale (NPRS) was utilized to measure pain intensity and Oswestry Disability Index (ODI) to measure functional disability. Data was analyzed by using SPSS 21.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Device: Low-intensity pulsed ultrasound (LIPUS), Other: Routine physical therapyLow-intensity pulsed ultrasound along with routine physical therapy |
| Control Group | Active comparator | Other: Routine physical therapyRoutine physical therapy alone |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both gender
- Diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months
- Age: 20-40 years
Key exclusion criteria (7 listed)
- Subjects with the history of neurological or autonomic deficits,
- Other fracture or bony abnormalities
- Rheumatic disease
- Other spinal problems
- Post-menopausal female
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 |
|---|---|---|
| Low-intensity pulsed ultrasound (LIPUS)Low-intensity pulsed ultrasound (LIPUS) consists of frequencies usually ranging from 0.75- 1.5 MHz at intensities <100mW/cm² (usually about 30mW/cm²) and usually pulsed at 1:4. The transducer head is strapped or otherwise held in place and remains stationary for treatment periods in the region of 20 minutes. Again, US medium is used for efficient sound transfer to deeper tissues. This modality was approved by the FDA in the United States in 1994 for the accelerated healing of fresh fractures and then approved by the same body in 2000 for the treatment of established non-union fractures. The studies presented to the FDA demonstrated that LIPUS had a positive effect during all three main stages of fracture healing, i.e. inflammatory, reparative and remodelling by enhancing angiogenesis, chondrogenesis and osteogenesis. | Device | Experimental Group |
| Routine physical therapyGentle hamstrings stretching for 15 seconds 3 times a day. Flexibility of these muscle reduces stress to the lumbar region thus enhances the spino-pelvic rhythm (lumbar motion/pelvic motion). Strengthening of abdominal muscles (transversus abdominis and internal oblique). Training of these "stability" muscles in the lumbar spine provides a solid foundation for the individuals to integrate them into their functional movement patterns. Exercises focusing on these muscles have been shown to significantly decrease pain and disability in people with spondylolysis. Each exercise will be performed as 3 sets of 10 repetitions on alternate days. | Other | Control Group, Experimental Group |
Primary outcome
Change from Baseline in Pain on Numeric Pain Rating Scale at week 12
Time frame: Baseline and Week 12
The Numerical Rating Scale (NPRS-11) is an 11-point scale for self-report of pain with a reliability of 0.96 and validity 0.86. It is the most commonly used unidimensional pain scale. The respondent selects a whole number (integers 0-10) that best reflects the intensity (or other quality if requested of his/her pain. Change = (Week 12 Score - Baseline Score)
Change from Baseline in the Functional Disability on Oswestry Disability Index at week 12
Time frame: Baseline and Week 12
The Oswestry Disability Index 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 with a reliability of 0.90 and validity 0.96. Scoring Instructions: For each section the total possible score is 5: if the first statement is marked the section score = 0; if the last statement is marked, it = 5. If all 10 sections are completed the score is calculated as follows: Example: 16 (total scored) 50 (total possible score) x 100 = 32% If one section is missed or not applicable the score is calculated: 16 (total scored) 45 (total possible score) x 100 = 35.5% Minimum detectable change (90% confidence): 10% points (change of less than this may be attributable to error in the measurement) Change = (Week 12 Score - Baseline Score)
2 secondary outcomes
Change from Baseline in Pain on Numeric Pain Rating Scale at week 20
Time frame: Baseline and Week 20
Change from Baseline in the Functional Disability on Oswestry Disability Index at and week 20
Time frame: Baseline and Week 20
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 29 Mar 2021.
- 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.
Fahad Tanveer, PhD principal investigator
University of Lahore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low-intensity pulsed ultrasound (LIPUS) and Routine physical therapy in people with Spondylolysis, run by University of Lahore 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 7 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 29 Mar 2021. 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?
Change from Baseline in Pain on Numeric Pain Rating Scale at week 12 (time frame: Baseline and Week 12). 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 29 Mar 2021.