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OsteoarthritisNCT02324192

Hand Ultrasonography: Clinical and Functional Correlation in Symptomatic Osteoarthritis (OA)

A study testing Ultrasonography in people with Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Objective: To evaluate the correlation / association between inflammatory ultrasonography findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings. Read more about this study

Who is it for?
Ages 40 years and older
Conditions the study is for
Osteoarthritis
What is being tested?
Ultrasonography
Could I receive a placebo?
No, everyone receives an active treatment
How many people
60 participants
Where
1 siteBrazil
Study dates
Aug 2011to Aug 2014
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 40 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of hand OA, according to the criteria of the American College of Rheumatology (ACR) (Altman et al., 1990) with involvement of proximal and / or distal IP joints
  • More than 40 years old
  • Visual analog scale of pain (VAS of 0-10 cm) in the joint of study between 3-8cm
  • And agree and sign the Consent Term of the study.

Who cannot join

  • Changed the use of oral corticosteroids and nonsteroidal anti-inflammatory drugs in the last thirty days
  • Changed the treatment of OA in the last two months (including drug and rehabilitation)
  • Radiography of hands suggesting interphalangeal arthropathy of other etiology (psoriatic arthritis, microcrystalline arthropathy).

Trial locations and contacts

1 site in 1 country.

Brazil1 site
  • Rheumatology of Federal University of São Paulo

    São Paulo, São Paulo, 04024-002

Other trials in Brazil

About this study

Objective: To evaluate the correlation / association between inflammatory ultrasonography findings and clinical /functional assessment in symptomatic hand OA interphalangeal joints (IP). To evaluate the intra and interobserver reproducibility of ultrasound findings.

Methods: It was conducted a prospective study in 60 symptomatic hand OA patients. They were assessed in six times (T0, T1, T4, T8, T12 and T48 weeks) by "blind" observers (clinical and ultrasonography). The intra and interobserver reproducibility analysis was performed in 25% of the sample. Differences were considered as statistically significant when p< 0.05.

Read the detailed description

Introduction Osteoarthritis (OA) is the most prevalent joint disease actually , hand OA is one of the characteristic subtypes. The estimated prevalence is 26% in over 70 years women. Treatment and follow-up of this disease have received less attention when compared to cases involving the knee and hip, probably because such involvement does not present with functional limitations as those seen in large joints.

For diagnosis and follow-up of hand OA the conventional radiography is used, although this exam give us an insight into just two planes of articulation and does not allow a reliable approach of tendons, muscles and other periarticular structures.

The ultrasound (US) appears as an emerging technique. More sensitive techniques are required for disease progression evaluation). It is a very useful imaging method, capable of showing early and late inflammation-related injuries and structural damage and is considered a great test to follow-up rheumatic diseases patients. Safe, easy to perform, low cost, fast and able to evaluate various sites attacked in the same turn, can be used in monitoring and evaluation of therapeutic response in these patients.

Some authors suggest that the sonographic evaluation is better than that of plain radiography, does not involve radiation and allows the joint evaluation at various sites. However, ultrasound still has limited use in hand OA compared to this use in inflammatory joint diseases.

The objectives of this study were to evaluate the correlation / association between ultrasonographic findings of inflammatory synovial hypertrophy and power Doppler of the interphalangeal joints(IP) and clinical and functional variables in patients with hand OA and test the intra and interobserver reproducibility of these ultrasonographic findings

Material and methods. A prospective study of ultrasonography in 60 patients with hand OA of was performed.

The inclusion criteria were: diagnosis of hand OA, according to the criteria of the American College of Rheumatology (ACR) with involvement of proximal and / or distal IP joints; more than 40 years old; visual analog scale of pain (VAS of 0-10 cm) in the joint of study between 3-8cm; and agree and sign the Consent Term of the study.

Exclusion criteria were: changed the use of oral corticosteroids and nonsteroidal anti-inflammatory drugs in the last thirty days; changed the treatment of OA in the last two months (including drug and rehabilitation); radiography of hands suggesting interphalangeal arthropathy of other etiology (psoriatic arthritis, microcrystalline arthropathy).

The most symptomatic joint was evaluated 60 patients in the study. Patients were evaluated at six times, having been made, so 360 assessments. Each in its dorsal recess (360) and palmar (360) recesses, accounting 720 joint recesses at the end of the study. Patients were from the outpatient rheumatology clinic of the Federal University of São Paulo (UNIFESP), Paulista Medical School, São Paulo, Brazil. The study was approved by the Research Ethics Committee of this Institution.

Evaluation Two "blind" observers (a clinical and a ultrasonography) evaluated the most symptomatic IP joint in the first assessment at the following times: T0, T1, T4, T8, T12 and T48 weeks.

At time 0 (T0) evaluation demographic data were collected and a plain radiograph of the hands was performed in anteroposterior view.

Clinical Evaluation Patients were evaluated in the six times according to the following assessment tools: visual analogue scale(VAS) of pain at rest of the studied joint (VASr 0-10 cm); VAS of the joint on movement(VASm of 0-10cm); VAS of joint swelling according to the evaluator (VASs 0-10cm); joint goniometry; need for analgesics (paracetamol 750mg daily average expressed in tablets / day); handgrip strength by Jamar dynamometer grip (instruction manual, PC 5030J1- Preston / Trenton, Ontario Canada; Mathiowetz, 1984) involving the studied joint hand; pinch strength (pulp-pulp, tripod and key) through the dynamometer Pinch Gauge (instruction manual, A853-4-Smith \& Nephew / Germantown, United States of America; Mathiowetz, 1984) in the studied finger; hand function assessed by the Brazilian version of two functional questionnaires, the COCHIN questionnaire and AUSCAN Index.

Ultrasound evaluation

The ultrasonography evaluation was performed after each clinical assessment, on all six times of evaluation by an experienced sonographer in musculoskeletal US. The US examination was carried out using a MyLab 60 Xvision (Esaote, Biomedica - Genova, Italy) using a linear transducer frequency 10-18 megahertz(MHz). The following ultrasonography parameters were evaluated: Synovial Hypertrophy (SH):

Quantitative measurement of synovial hypertrophy(SH): This measurement was made between the bone surface to the the joint capsule of the dorsal and palmar recess in each assessment and expressed in millimeters (mm).

Semiquantitative measurement of SH: assessed by a semiquantitative score ranging from 0 to 3, modified for the proximal IP (PIP) and distal (IFD) from the score created by Szkudlarek and collaborators in 2003. According to this score:Grade 0 = no fluid; B, grade 1 = minimal amount of fluid; C, grade 2 = moderate amount of fluid (without distension of the joint capsule); D, grade 3 = extensive amount of fluid (with distension of the joint capsule). Scores 0 or 1 were considered normaland pathological scores 2 or 3.

Synovial Blood Flow: estimated by the presence of signal power Doppler (PD) which was also graded 0-3. Grade 0 = no flow in the synovium; grade 1 = single vessel signals; grade 2 = confluent vessel signals in less than half of the area of the synovium; grade 3 = vessel signals in more than half of the area of the synovium. The pulse repetition frequency (PRF) was maintained between 500 and 1000 Hz The frequency varied between 6.3 and 10 MHz. It was considered normal grade 0 and pathological grade 1, 2 and 3.

Intraobserver and interobserver reproducibility of ultrasound evaluation Assessment of intra- and interobserver reproducibility was performed for quantitative and semiquantitative measures of SH and PD. This evaluation was done in 25% of the sample (90 joint recesses).

In this analysis two ultrasonographers were involved. The first was responsible for ultrasonographic evaluation of the entire sample. In addition, he was also responsible for conducting a second ultrasound measure used to assess intraobserver reproducibility. The second ultrasonographer was responsible for ultrasonographic evaluation used to assess inter-observer reproducibility. During the evaluation of the first ultrasonographer images were evaluated and then recorded. Such images recorded were identified with numbers (and not with the patient's name) and evaluated by the same ultrasonographer (first ultrasonographer) with more than 60 days interval. The second ultrasonographer did the ultrasound evaluation in images recorded by the first ultrasonographer completely independently.

Statistical Analysis Continuous data sample were described by mean and standard deviation (SD). Categorical data were expressed as frequencies and percentages. Continuous variables sample were tested with normality Kolmogorov-Smirnov test; Spearman correlation were used for continuous variables; Mann-Whitney test for the association between continuous and categorical variables and the chi-square test for categorical variables.

Reproducibility assessment for ultrasonography measurements was performed using the kappa test and the intraclass correlation coefficient (ICC).

Differences were considered as statistically significant when p< 0.05

Conditions
Osteoarthritis
Being tested
Ultrasonography
Keywords
Ultrasonography, clinical, hand
Medical subject headings
Osteoarthritis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • UltrasonographyOther

    imaging findings

Study groups in NCT02324192
Study groupRoleWhat they receive
Normal ultrasonographyOtherPatients with normal ultrasonography findings
Receives: Other: Ultrasonography
Inflammatory ultrasonographyOtherPatients with inflammatory ultrasonography findings
Receives: Other: Ultrasonography

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline - Correlation between VASr(Visual Analogic Scale of pain at rest 0-10cm) and ultrasonography findings(Grey Scale and power Doppler) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

Secondary outcomes (7)
  1. Change from baseline - Correlation between VASs(Visual Analogic Scale of joint swelling 0-10cm) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint)) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  2. Change from baseline - Correlation between joint goniometry(°) and ultrasonography findings ( determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  3. Change from baseline - Correlation between use of analgesics(tablets per day of paracetamol) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  4. Change from baseline - Correlation between handgrip strength determined by Jamar dynamometer grip(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  5. Change from baseline - Correlation between pinch strength determined by the dynamometer of Pinch Gauge(kgf) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  6. Change from baseline - Correlation between hand function(determined by AUSCANindex and COCHIN questionnaire) and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

  7. Change from baseline - Correlation between VAS of the joint on movement and ultrasonography findings(determined using the Grey Scale and power Doppler in affected joint) at 1year in six times

    Measured: 0,1,4,8,12 and 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Dec 2014 (estimated)
  2. Study startAug 2011
  3. Primary completionAug 2012
  4. Study completionAug 2014

Resources

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
Allocation
Randomised
Intervention model
Single group
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02324192
Sponsor's protocol ID
FUSaoPaulo002
Status last verified
Dec 2014
First submitted
9 Dec 2014
Last updated
24 Dec 2014
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Ultrasonography in people with Osteoarthritis, run by Federal University of São Paulo at 1 site in Brazil.

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 4 inclusion and 3 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 24 Dec 2014. 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 Brazil. 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 - Correlation between VASr(Visual Analogic Scale of pain at rest 0-10cm) and ultrasonography findings(Grey Scale and power Doppler) at 1year in six times (time frame: 0,1,4,8,12 and 48 weeks). 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 24 Dec 2014.

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