Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis

May 15, 2019 updated by: Marcia Uchoa Rezende, University of Sao Paulo General Hospital

Comparative Study of the Intraarticular Treatment of Carpometacarpal Joint Ostearthritis of the Thumb With Lavage With Saline Solution, or Lavage and Injection of Hyaluronic Acid and Mannitol.

Although a common problem, hand osteoarthritis (HOA) is less studied than knee and hip. In the age group of 71-100 years, the prevalence of symptomatic HOA reaches 26% of women and 13% of men. These patients lose hand strength and have difficulty with day-to-day manual activities. The main joints involved are the proximal and distal interphalangeals and the carpometacarpal joint of the thumb. In the educational Project PARQVE, the prevalence of HOA was 23.7% at inclusion in the program, and 47.4% after one year, with loss of grip strength. There is controversy over the effect of viscosupplementation in the treatment of rhizarthritis when considering pain. However, strength is a very important function parameter that must be evaluated for function and quality of life maintenance. Concerned about the importance of maintaining strength and function in our program (PARQVE), we have added specific exercises tom improve hand strength and range of motion. Trying to optimize the treatment and confronting questions about the effect of the joint wash, called placebo in the comparative studies with corticosteroid and/or hyaluronic acid injection, we did a work where all the patients will be washed with physiological saline solution but a group, after emptying, will receive 1mL of hyaluronic acid with mannitol.

PURPOSE: To compare isolated lavage with lavage followed by injection of hyaluronic acid with mannitol into carpometacarpal osteoarthritis joint of the thumb.

METHODS: Forty joints of patients with multiple osteoarthritis (rhizoarthritis, including) and comorbidities (two or more of: overweight or obesity, hyperglycemia, dyslipidemia, hyperuricemia, hypertension) will be allocated into two groups: Lavage (LS) and Lavage and Injection Hilauronic acid (LO). Both groups will undergo joint lavage with saline solution. The LO group will receive the 20 mg / mL hilauronic acid injection with 5mg mannitol. Both groups will be guided in the clinical treatment of osteoarthritis and metabolic syndrome and will be given daily exercises for the hands. They will be evaluated with the quick DASH questionnaire, Sollerman Test and by measuring the palmar, lateral and pulp-pulp grip strength, in addition to measuring the ROM and VAS pain moments immediately prior to the procedure, one, three and six months after the articular procedure.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Patients with multiple osteoarthritis (including carpometacarpal joint of the thumb, stages I to III - Eaton et al.) in treatment at the Institute of Orthopedics and Traumatology fo the Clinics Hospital - University of São Paulo (IOT-HC-FMUSP) will be invited to participate in this study.

All patients are obliged to participate in a two-day education course on OA. During the program they are instructed about OA, metabolic syndrome, comorbidities and importance of diet, and daily exercise (including specific exercises for the hand).

After inclusion, 40 joints will be randomized in one of two treatment options, i.e., Lavage with saline solution and final injection of 1mL of saline solution, or lavage with saline solution followed by injection of 10mg of hyaluronic acid with mannitol (5mg).

After the procedure patients will receive naproxen 500mg twice daily for 5 days.

Patients will be instructed to exercise at least 180 minutes/week and if possible daily exercise for the hand (5 to 10 minutes daily).

Patients will be instructed to write down when and what they exercised as well as their daily medication intake (for co-morbidities and pain).

All patients will be submitted to pain (VAS), range of motion (ROM), Quick DASH, Sollermand Test and functional (palmar grip strength and lateral and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.

As the assessments of pain, range of motion and strength will be compared with measurements of the same limb at inclusion, each hand involved of the patient will be considered as a case.

The "n" was calculated to obtain a statistical power of 80% and a level of significance of 5%. To do this, we considered the mean and standard deviation of the pulp-pulp pinch (our primary outcome) found in previous study of the prevalence of hand OA in individuals with knee osteoarthritis submitted to our educational program. A sample size was used to detect a variation of 1 point on the two-tailed pulp-pulp pinches. The sample size calculated by group was 16. Considering also possible faults and abandon of about 20% of the patients, the value of 20 patients per group was obtained.

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • São Paulo, SP, Brazil, 05403010
        • Instituto de Ortopedia e Traumatologia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men and women diagnosed with multiple arthritis (including CMC OA of the thumb) with comorbidities (metabolic syndrome, i.e., OA and overweight / obesity, and/or hyperglycemia, and/or dyslipidemia, and/or hyperuricemia, and/or hypertension).
  • CMC OA joint of the thumb stages I to III as classified by Eaton et al. (4)

Exclusion Criteria:

  • Missing classes or functional evaluations
  • Not performing the exercises as instructed

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Lavage with Saline (LS)

Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to joint lavage with physiologic saline solution 2 to 5 mL (injection with a 30x8 needle and drained with the same needle after removal of the syringe. After emptying of the joint, 1mL saline solution will be injected.

Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
Behavioral: Visual Analog Scale (VAS)
Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
Behavioral: Range of Motion (ROM)
submitted to ROM at at baseline, 1 month, 3 months and 6 months
Behavioral: Palmar grip strength
submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
Behavioral: Lateral grip strength
submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
Behavioral: Pulp-pulp pinch strength
submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
Drug: Lavage with physiologic saline solution
Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.
Other Names:
  • Lavage with Saline (LS)
Behavioral: Quick Dash
Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
Behavioral: Sollerman Test
Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
EXPERIMENTAL: Lavage with Osteonil® Mini (LO)

Under sterile conditions, the 1st carpometacarpal (CMC) will be locally anesthetized with ropivacaine and will be submitted to lavage with physiologic saline solution and Osteonil® Mini 1mL of 10mg will be injected in the 1st CMC joint.

Patients will ask to answer Visual Analog Scale (VAS) questionnaire, Range of Motion (ROM), Quick DASH, Sollerman Test, and functional grip strength (palmar grip strength, lateral grip strength and pulp-pulp pinch strength) evaluations immediately prior to the procedure and after 1, 3 and 6 months of each joint.
Behavioral: Visual Analog Scale (VAS)
Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months
Behavioral: Range of Motion (ROM)
submitted to ROM at at baseline, 1 month, 3 months and 6 months
Behavioral: Palmar grip strength
submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months
Behavioral: Lateral grip strength
submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months
Behavioral: Pulp-pulp pinch strength
submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months
Behavioral: Quick Dash
Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months
Behavioral: Sollerman Test
Perform Sollerman Test at baseline, 1 month, 3 months and 6 months
Drug: Lavage with physiologic saline solution and Osteonil® Mini
Joint lavage with physiologic saline solution and Osteonil® Mini
Other Names:
  • Lavage with Osteonil® Mini (LO)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement in grip strength at 6 months
Time Frame: Baseline, 1 month, 3 months and 6 months.
Perform test and collected data in baseline, 1 month, 3 months and 6 months.
Baseline, 1 month, 3 months and 6 months.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess improvement in pain
Time Frame: Baseline, 1 month, 3 months and 6 months.
Answer VAS (Visual Analog Scale)
Baseline, 1 month, 3 months and 6 months.
Assess improvement in range of motion
Time Frame: Baseline, 1 month, 3 months and 6 months.
Measure range of motion
Baseline, 1 month, 3 months and 6 months.
Assess improvement in palmar grip strength
Time Frame: Baseline, 1 month, 3 months and 6 months.
Perform palmar grip strength
Baseline, 1 month, 3 months and 6 months.
Assess improvement in lateral pinch strength.
Time Frame: Baseline, 1 month, 3 months and 6 months.
Perform lateral pinch strength.
Baseline, 1 month, 3 months and 6 months.
Assess improvement in Pulp-pulp pinch strength
Time Frame: Baseline, 1 month, 3 months and 6 months.
Perform pulp-pulp pinch strength
Baseline, 1 month, 3 months and 6 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • Principal Investigator: Marcia U Rezende, MD; PhD, Department of Orthopedics and Traumatology - HCFMUSP

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2017

Primary Completion (ACTUAL)

March 30, 2018

Study Completion (ANTICIPATED)

August 30, 2019

Study Registration Dates

First Submitted

January 12, 2017

First Submitted That Met QC Criteria

March 17, 2017

First Posted (ACTUAL)

March 24, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 16, 2019

Last Update Submitted That Met QC Criteria

May 15, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14733/16

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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