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

NCT04814979 | Completed DMC

• 1 other identifier: IRB-UOL-FAHS-UIPT/690/2020
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Spondylolysis

Keywords

lumbar vertebra; pain; functional disability; low-intensity pulsed ultrasound

Outcome Measures

Primary Outcomes (2)

• 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)

  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)

  Baseline and Week 12

Secondary Outcomes (2)

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

  Baseline and Week 20

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

  Baseline and Week 20

Study Arms (2)

Experimental Group

EXPERIMENTAL

Low-intensity pulsed ultrasound along with routine physical therapy

Device: Low-intensity pulsed ultrasound (LIPUS); Other: Routine physical therapy

Control Group

ACTIVE COMPARATOR

Routine physical therapy alone

Other: Routine physical therapy

Interventions

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.

Experimental Group

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.

Control Group; Experimental Group

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Lahore: lead

Study Sites (1)

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

Lahore, Punjab Province, 74000, Pakistan

Location

MeSH Terms

Conditions

Spondylolysis; Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• Fahad Tanveer, PhD

  University of Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 20, 2021
• First Posted: March 24, 2021
• Study Start: June 15, 2020
• Primary Completion: March 15, 2021
• Study Completion: March 15, 2021
• Last Updated: March 29, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)