Hands Osteoarthritis Clinical Trial
Official title:
Effectiveness of Triamcinolone Hexacetonide Intra-articular Injection in Interphalangeal Joints: a 12 Weeks Randomized Controlled Trial in Osteoarthritis Hand Patients
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.
Background The aim of this study was to evaluate the effectiveness and tolerance of
medium-term IAI of corticosteroids HT for the treatment of OA in proximal interphalangeal
joints(PIP) or distal interphalangeal joints(DIP) joints on clinical and functional
parameters.
Studies evaluating the effectiveness of intra-articular therapies in patients with hands OA
are very heterogeneous, either by addressing different types of joints at the same time, for
wearing unusual drugs, for failing to placebo groups , by using very soluble corticosteroid
or not using corticosteroids.
Design A randomized, prospective, controlled, double-blinded, intention to treat study was
performed.
Sample Patients were collected from the outpatient clinics of the Federal University of Sao
Paulo, from August 2011 to August 2012. A total of 60 patients were randomized into two
groups of 30 patients.
The patients had to fulfill the following inclusion criteria: diagnosis of PIP or DIP hands
OA according to the American College of Rheumatology criteria, age greater than 40 years,
and pain in at least one PIP or DIP hand joints between 3-8 cm on Visual Analog Scale for
pain (VAS for pain at rest 0-10cm).
Patients with change in the corticosteroids or nonsteroidal antiinflammatory drug in the
last thirty days; change in chondroprotective drugs in the last two months; IAI with
corticosteroids in the studied joint in the last three months; any change in hand OA
treatment in the last two months (rehabilitation, acupuncture and others); suspicion of
local or systemic infection; hand x-ray suggesting another etiology of hand arthropathy
(psoriatic arthritis, microcrystalline arthropathy, deposit disease) and severe coagulation
disorder.
Intervention Patients were randomized into two groups. The study group was called
hexacetonide triamcinolone / lidocaine (TH / LD) and a control group, called lidocaine (LD).
Patients in TH / LD group underwent treatment scheme in its most symptomatic interphalangeal
(IP) joint composed of IAI with HT (20mg/ml) and 2% lidocaine without vasoconstrictor. The
IAI was realized in the 0.3 ml dose (6mg) of HT for PIP and 0.2 ml (4 mg) of HT for DIP,
always associated with 0.1 mL of 2% 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) for both groups. Both groups of patients underwent only one IAI in the most symptomatic
joint and on a single occasion.
The procedures of the two groups were performed blindly by the same rheumatologist with 10
years of experience in interventional rheumatology 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 14 (Figure 1). After the procedure, the injected joint was immobilized
for 48 hours, in both groups.
Assessment All patients had their data reported in an evaluation form. The data collected
were: age, sex, race, use of chondroprotective drugs, anti-inflammatory and / or analgesics
drugs. Hands x-ray was performed in anteroposterior view for study inclusion. The
measurement was done according to the method of Kellgren and Lawrence and used to evaluate
homogeneity of the sample.
Five assessment evaluations were scheduled for a total of 12 weeks of follow-up. Patients
were assessed at T0 (before intervention), T1, T4, T8 and T12 weeks after intervention. The
assessment was carried out by a "blinded" assessor, trained in assessment instruments. This
study was an intention to treat study. The last observation carried forward in case of
discontinuation.
Clinical assessment
The following parameters were assessed in both groups:
- Visual analogue scale (VAS) for rest pain (VASr 0- 10cm);
- VAS for movement pain (VASm 0- 10cm);
- VAS for joint swelling (VASs 0- 10cm);
- Joint goniometry in flexion (degrees of range of motion);
- Analgesic consumption after the intervention (paracetamol daily average);
- 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 16;
- Hand function assessed by COCHIN questionnaire and the AUSCAN Index using the
sub-scales pain, stiffness and hand function;
- Treatment improvement scale varying 5 points (much worse, worse , unchanged, little
improvement and much improved);
- Side effects following the procedure (atrophy and / or cutaneous hypochromia and joint
instability);
- Worsening of pain after IAI measured by VAS (post IAI VAS 0- 10cm) in 48 hours after
the procedure (reported only at T1) in both groups.
Sample Size Using the VAS for pain as the primary study variable, considering a standard
deviation equal to 1.5 points, based on previous work , and using the ANOVA for repeated
measures as the statistical method for the calculation of the sample, with power of 90%, 5%
significance and a detectable difference of 2.0 points on the VAS pain scale, measured 5
times over time into two independent groups, the investigators found a sample of 24 patients
for each group. Considering a possible loss of up to 20% of patients over time, the
investigators started the study with 30 patients in each group.
Randomization Patients were randomized using the MINITAB 14.0 software, with secret
allocation guaranteed by opaque sealed envelopes. The responsible for the inclusion of these
patients had no prior access to randomization list; it was responsible for verifying that
the patient was within the inclusion and exclusion criteria of the study and after this
procedure refer patients to the evaluators in another room, where medication was prepared.
Sample Blinding Only the responsible for the inclusion / exclusion of patients had access to
which group the patient belonged, after enrollment. Evaluators and the responsible for the
procedure had no access to such information. This blinding was relative impaired, since the
volume used in the infiltration group TH / LD was substantially greater than that used in
the LD group. However the responsible for the procedure was not responsible for the
recruitment/allocation or evaluation of the sample. Regarding this essay the evaluators did
not identify problems related to "blinding" during the study.
Statistical methods SPSS software version 17.0 (Chicago, IL) was used to perform statistical
analysis. The descriptive statistics (mean, standard deviation, confidence interval 95%) was
used to characterize the patients in groups. Continuous variables of the 2 groups at
baseline were compared using the Student t test (for normally distributed variables) and the
Mann-Whitney test (for variables with distribution not considered normal). Categorical
variables were evaluated using the chi-square test.
To assess the response to intervention, analysis of variance (ANOVA) with repeated measures
was used to intragroup and intergroup analysis over time.
This study was considered statistically significant if p values <0.05.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment