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Completed

NCT Number: NCT04814979

Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis

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.

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Key information

Conditions

Spondylolysis Bone Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylosis

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institutional Review Board of Faculty of Allied Health Sciences, University of Lahore

Lahore, Punjab Province, 74000, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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 therapy

Other

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.

Primary outcomes

  1. 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)

  2. 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)

Secondary outcomes

  1. Change from Baseline in Pain on Numeric Pain Rating Scale at week 20

    Time frame: Baseline and 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)

  2. Change from Baseline in the Functional Disability on Oswestry Disability Index at and week 20

    Time frame: Baseline 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)

Sponsors and collaborators

Lead sponsor

University of Lahore

Other

Registry information

Official study title

Effects of Low-intensity Pulsed Ultrasound on Pain and Functional Disability in Patients With Lumbar Spondylolysis: A Randomized Controlled Trial

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Mar 24, 2021
Registry last updated
Mar 29, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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