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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02086357
Other study ID # RD13/10834
Secondary ID 14845
Status Recruiting
Phase N/A
First received January 23, 2014
Last updated February 19, 2015
Start date July 2013

Study information

Verified date February 2015
Source The Leeds Teaching Hospitals NHS Trust
Contact Maria Johnson
Email maria.johnson@leedsth.nhs.uk
Is FDA regulated No
Health authority United Kingdom: Research Ethics Committee
Study type Observational

Clinical Trial Summary

Ultrasound (US)tissue elastography has recently been found to have a number of clinical applications in the assessment of soft tissue disease for example, in breast and thyroid pathology. There are few current studies exploring its use in musculoskeletal pathology, particularly a new technique called sheer wave ultrasound elastography (SWUE).

Magnetic Resonance (MR) elastography has shown wide reaching applications in orthopaedics, sports medicine and rheumatology and SWUE may have the potential to also demonstrate clinical effectiveness in these areas.

Our aim is to explore the effectiveness of this technique in the assessment of musculoskeletal pathology.

Participants will be recruited through current referral protocols and would undergo an additional elastographic investigation in addition to their standard US examination. This investigation will be conducted within the musculoskeletal US department at Chapel Allerton Hospital by trained musculoskeletal specialists. The study will be conducted over a period of approximately 24 months with quarterly review during this time.


Recruitment information / eligibility

Status Recruiting
Enrollment 500
Est. completion date
Est. primary completion date December 2016
Accepts healthy volunteers No
Gender Both
Age group 16 Years and older
Eligibility Inclusion Criteria:

- Have clinical symptoms and signs of soft tissue pathology

- Be able to give consent

- Be over 16 years of age

Exclusion Criteria:

- Unable to give consent

- 16years of age or less

- Multifactorial soft tissue pathology

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
SWUE


Locations

Country Name City State
United Kingdom Leeds Teaching Hospital NHS Trust Leeds

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Clinical effectiveness of Sheer wave ultrasound elastography (SWUE) in the assessment of soft tissue pathology Ability of SWUE to accurately detect soft tissue pathology when compared with standard ultrasound techniques. Baseline to 24 months No