Saline Lavage X Saline Lavage and Osteonil® Mini in Rizarthritis

NCT03089723 | Unknown

• 1 other identifier: 14733/16
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Rhizarthrosis; Metabolic Disease

Keywords

carpometacarpal joint ostearthritis; hyaluronic acid; Rhizarthrosis

Outcome Measures

Primary Outcomes (1)

• Improvement in grip strength at 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 Outcomes (5)

• Assess improvement in pain

  Baseline, 1 month, 3 months and 6 months.

• Assess improvement in range of motion

  Baseline, 1 month, 3 months and 6 months.

• Assess improvement in palmar grip strength

  Baseline, 1 month, 3 months and 6 months.

• Assess improvement in lateral pinch strength.

  Baseline, 1 month, 3 months and 6 months.

• Assess improvement in Pulp-pulp pinch strength

  Baseline, 1 month, 3 months and 6 months.

Study Arms (2)

Lavage with Saline (LS)

EXPERIMENTAL

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); Behavioral: Range of Motion (ROM); Behavioral: Palmar grip strength; Behavioral: Lateral grip strength; Behavioral: Pulp-pulp pinch strength; Drug: Lavage with physiologic saline solution; Behavioral: Quick Dash; Behavioral: Sollerman Test

Lavage with Osteonil® Mini (LO)

EXPERIMENTAL

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); Behavioral: Range of Motion (ROM); Behavioral: Palmar grip strength; Behavioral: Lateral grip strength; Behavioral: Pulp-pulp pinch strength; Drug: Lavage with physiologic saline solution and Osteonil® Mini; Behavioral: Quick Dash; Behavioral: Sollerman Test

Interventions

Visual Analog Scale (VAS) BEHAVIORAL

Answer Visual Analog Scale (VAS) questionnaire at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Range of Motion (ROM) BEHAVIORAL

submitted to ROM at at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Palmar grip strength BEHAVIORAL

submitted to palmar grip strength at at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Lateral grip strength BEHAVIORAL

submitted to lateral grip strength at at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Pulp-pulp pinch strength BEHAVIORAL

submitted to pulp-pulp pinch strength strength at at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Lavage with physiologic saline solution DRUG

Joint lavage with physiologic saline solution. After emptying of the joint, 1mL saline solution will be injected.

Also known as: Lavage with Saline (LS)

Lavage with Saline (LS)

Lavage with physiologic saline solution and Osteonil® Mini DRUG

Joint lavage with physiologic saline solution and Osteonil® Mini

Also known as: Lavage with Osteonil® Mini (LO)

Lavage with Osteonil® Mini (LO)

Quick Dash BEHAVIORAL

Answer Quick Dash questionnaire at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Sollerman Test BEHAVIORAL

Perform Sollerman Test at baseline, 1 month, 3 months and 6 months

Lavage with Osteonil® Mini (LO); Lavage with Saline (LS)

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Instituto de Ortopedia e Traumatologia

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (24)

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  PMID: 23333279 BACKGROUND

• de Campos GC, Rezende MU, Pailo AF, Frucchi R, Camargo OP. Adding triamcinolone improves viscosupplementation: a randomized clinical trial. Clin Orthop Relat Res. 2013 Feb;471(2):613-20. doi: 10.1007/s11999-012-2659-y. Epub 2012 Oct 26.

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MeSH Terms

Conditions

Metabolic Diseases

Interventions

Range of Motion, Articular; Therapeutic Irrigation; Sodium Chloride

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Hydrotherapy; Physical Therapy Modalities; Therapeutics; Rehabilitation; Investigative Techniques; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Marcia U Rezende, MD; PhD

  Department of Orthopedics and Traumatology - HCFMUSP

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD; PhD

Study Record Dates

• First Submitted: January 12, 2017
• First Posted: March 24, 2017
• Study Start: March 30, 2017
• Primary Completion: March 30, 2018
• Study Completion: August 30, 2019
• Last Updated: May 16, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)