Clinical trial NCT04814979: Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis
Official title: Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spondylolysis
Keywords: lumbar vertebra
pain
functional disability
low-intensity pulsed ultrasound
Lead sponsor: University of Lahore
Sponsor class: OTHER
First posted: 2021-03-24
Enrollment: 34
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* Both gender
* Diagnosed subjects of lumbar spondylolysis with symptomatic low back pain since four months
* Age: 20-40 years

Exclusion Criteria:

* Subjects with the history of neurological or autonomic deficits,
* Other fracture or bony abnormalities
* Rheumatic disease
* Other spinal problems
* Post-menopausal female
* Osteoporosis
* Osteopenia

Primary outcomes:
measure: Change from Baseline in Pain on Numeric Pain Rating Scale at week 12
timeFrame: Baseline and Week 12
measure: Change from Baseline in the Functional Disability on Oswestry Disability Index at week 12
timeFrame: Baseline and Week 12
Secondary outcomes:
measure: Change from Baseline in Pain on Numeric Pain Rating Scale at week 20
timeFrame: Baseline and Week 20
measure: Change from Baseline in the Functional Disability on Oswestry Disability Index at and week 20
timeFrame: Baseline and Week 20
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Institutional Review Board of Faculty of Allied Health Sciences, University of Lahore
state: Punjab
Study officials:
affiliation: University of Lahore
name: Fahad Tanveer, PhD
role: PRINCIPAL_INVESTIGATOR
References: