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Corticosteroid Intra-articular Injection in Hands Osteoarthritis

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ClinicalTrials.gov Identifier: NCT02102620
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : April 3, 2014
Sponsor:
Information provided by (Responsible Party):
Natalia de Oliva Spolidoro Paschoal, Federal University of São Paulo

Brief Summary:

Objective - to evaluate the effectiveness and tolerance of intra-articular injections (IAI) of hexacetonide triamcinolone (HT) for the treatment of osteoarthritis (OA) in interphalangeal joints.

Design:randomized, controlled, double-blinded study Materials and methods: sixty patients were randomized into: the TH / lidocaine (LD) group (n=30) who underwent IAI at the most symptomatic interphalangeal joint with HT (20mg/ml) and LD 2% or the LD group (n=30) who received IAI with just LD. Patients were assessed at baseline, 1, 4, 8 and 12 weeks by a blinded observer. The following parameters regarding the affected joint were assessed: pain at rest (VASr); pain at movement (VASm); pain (VAS) during the 48 hours after the procedure; swelling (VASs); goniometry; grip and pinch strength; hand function; treatment improvement; daily requirement of paracetamol and incidence and types of local side effects after the procedure.


Condition or disease Intervention/treatment Phase
Hands Osteoarthritis Drug: Intra-articular injection with corticosteroid Drug: Intra-articular injection with lidocaine Phase 4

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effectiveness of Triamcinolone Hexacetonide Intra-articular Injection in Interphalangeal Joints: a 12 Weeks Randomized Controlled Trial in Osteoarthritis Hand Patients
Study Start Date : August 2011
Actual Primary Completion Date : August 2012
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IAI triamcinolone hexacetonide

Intra-articular injection with corticosteroid . The study group was called triamcinolone hexacetonide / lidocaine (TH / LD) and a control group, called lidocaine (LD).

Patients in TH / LD group underwent corticosteroid IAI scheme in its most symptomatic interphalangeal (IP) joint composed with triamcinolone hexacetonide(TH) (20mg/ml) and 2% lidocaine without vasoconstrictor. The IAI was realized in the 0.3 ml dose (6mg) of TH for PIP and 0.2 ml (4 mg) of HT for DIP, always associated with 0.1 mL of 2% lidocaine. Paracetamol 750 mg / tablet were also used if required during the 12 weeks of follow-up (up to 03 tablets per day).

Drug: Intra-articular injection with corticosteroid
After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.
Other Name: triancil

Placebo Comparator: IAI lidocaine
Intra-articular injection with lidocaine. The LD group patients underwent IAI with only 2% lidocaine without vasoconstrictor in its most symptomatic IP joint. Paracetamol 750 mg / tablet were also used if required during the 12 weeks of follow-up (up to 03 tablets per day) . Both groups of patients underwent only one IAI in the most symptomatic joint and on a single occasion.
Drug: Intra-articular injection with lidocaine
After rigorous antisepsis with alcoholic 0.5% chlorhexidine. Sterile insulin syringe BD ™ Ultra Fine needles 8 mm x 0.3 mm 30 G) was used in all patients. The anatomical place used for needle entry was located in the dorsal - lateral joint aspect. After the procedure, the injected joint was immobilized for 48 hours.
Other Name: Xylestesin




Primary Outcome Measures :
  1. Change from baseline in Pain Score on the Visual Analogue Scale (VAS) at 3 months [ Time Frame: 0 -1-4-8 and 12 weeks ]
    To evaluate the improvement on pain measure by:VAS for rest pain (VASr 0- 10cm) and movement (VASm 0- 10cm) in each time


Secondary Outcome Measures :
  1. Safety at 3 months [ Time Frame: 0-1-4-8 and 12 weeks ]
    Side effects following the procedure (atrophy and / or cutaneous hypochromia and joint instability);


Other Outcome Measures:
  1. Change from Baseline in Hand function at 3 months [ Time Frame: 0-1-4-8 and 12 weeks ]
    Hand function assessed by COCHIN scale and the Australian/Canadian (AUSCAN)Osteoarthritis Hand Index using the sub-scales pain, stiffness and hand function.

  2. Change from Baseline on Goniometry at 3 months [ Time Frame: 0-1-4-8 and 12weeks ]
    Joint goniometry in flexion (degrees of range of motion)

  3. Change from Baseline in Hand strength at 3 months [ Time Frame: 0-1-4-8 and 12 weeks ]
    Grip strength using Jamar® dynamometer (kgf) by obtaining the average of three attempts; Pinch strength using dynamometer Pinch Gauge (kgf) - by obtaining the average of three trials for the three types of pinches: tip, key and tripod.

  4. Change from Baseline in Analgesic consumption at 3 months [ Time Frame: 0-1-4-8 and 12weeks ]
    Analgesic consumption after the intervention (paracetamol daily average).

  5. VAS pain after procedure [ Time Frame: 48 hours ]
    Worsening of pain after IAI measured by VAS (post IAI VAS 0- 10cm) in 48 hours after the procedure

  6. Change from Baseline in Subjective analysis of improvement at 3 months [ Time Frame: 1-4-8 and 12 weeks ]
    Treatment improvement scale varying 5 points (much worse, worse , unchanged, little improvement and much improved).



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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hand OA
  • Age over 40
  • Visual analogic scale (VAS) for pain at rest between 3-8cm
  • Signed informed consent term

Exclusion Criteria:

  • Change in the use of oral corticosteroid or nonsteroidal antiinflammatory (NSAID) in the last 30 days
  • Change in drugs for OA in the last two months
  • IAI in this joints in the last three months
  • Any change in treatment for OA in the hands in the last two months
  • Suspicion of local and or systemic infection, and pregnancy
  • Hands X-ray suggesting arthropathy of the interphalanges of other etiology
  • Serious coagulation disorder

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02102620


Locations
Brazil
Federal University of São Paulo
São Paulo, SP, Brazil, 04023-061
Sponsors and Collaborators
Federal University of São Paulo
Investigators
Principal Investigator: Natalia O Spolidoro Paschoal Federal University of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Natalia de Oliva Spolidoro Paschoal, Physician, Federal University of São Paulo
ClinicalTrials.gov Identifier: NCT02102620     History of Changes
Other Study ID Numbers: FUSaoPauloRheum01
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: April 3, 2014
Last Verified: March 2014

Keywords provided by Natalia de Oliva Spolidoro Paschoal, Federal University of São Paulo:
intra-articular injection
corticosteroid
osteoarthritis
Interphalangeal joint

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Lidocaine
Triamcinolone hexacetonide
Triamcinolone
Triamcinolone Acetonide
Triamcinolone diacetate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors