This will be a prospective, multi-center, double-blinded, randomized study designed to compare the efficacy of Conventional Radiofrequency (CRF) and the anesthetic block of the anterior sensory branches to the hip to control pain and improve function related to hip osteoarthritis.
This prospective, double-blinded (participant and outcome assessor) clinical trial was designed to investigate the results of the intervention Continuous Radiofrequency (CRF) in the treatment of participants with chronic hip pain secondary to hip osteoarthritis. Participants will be randomized in a 2-arm, parallel groups. The intervention group will be submitted to an anesthetic block of the sensory branches of femoral and obturator nerves to the hip, with 1 ml of 1% lidocaine with 1ml of steroid (Betamethasone Dipropionate 5 mg/ml + Betamethasone Sodium Phosphate 2 mg/ml) for each branch, followed by denervation with CRF (22¬gauge 5¬mm active tip cannula, 10cm in length) with the tip temperature set at 90° C in a single cycle of 90 min. The sham group will be submitted to the same anesthetic block, followed by a simulation of CRF use. The surgeon performing the procedures will only be informed of the randomization after completing the anesthetic block on the participants to avoid bias at its accuracy. Participants will be evaluated at four follow-up: before intervention and after 1, 12, and 24 weeks, to access the Western Ontario and McMaster Universities score (WOMAC) as the primary outcome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
36
Steroid and anesthetic extra articular injection followed by denervation using CRF at 90 celsius degree during a period 90 minutes at the sensitive branches of obturator and femoral nerve, separately.
Corticosteroid and anesthetic extra articular injection at the sensitive branches of obturator and femoral nerve, only
Hospital das Forças Armadas
Brasília, Federal District, Brazil
Quality of Life (WOMAC)
The Western Ontario and McMaster Universities (WOMAC) is a self-administered health status measure and consists of 24 items divided into three domains, which are pain (5 questions), stiffness (2 questions), and physical function (17 questions), validated to patients with hip or knee osteoarthritis, available in a 5-point Likert scale, ranging from 0 to 96 points.This questionnaire is translated and validated in portuguese.
Time frame: Baseline to 24 weeks ± 1 week.
Change in Pain Visual Analogue Scale
The pain visual analogue scale (VAS) is a unidimensional measure of pain intensity, in a continuous scale comprised of a horizontal line, 10 centimeters (100 mm) in length, anchored by 2 verbal descriptors, one for each symptom extreme, "no pain" (score 0) and " worst pain ever" (score 100).
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Harris Hip Score (HHS)
The Harris Hip Score (HHS) is a joint-specific measure, and it consists of two sections: questions and a physical examination, including a range of motion and deformity items. The score has a maximum of 100 points with a maximum of 44 points for pain, 47 for function, 4 points for absence of deformity, and 5 points for a range of motion. The highest score of 100 points indicates the best function and no pain.
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Pain Medication Intake
To evaluate pain medication we will use a scale ranging from 0 to 4 (0= no medication; 0 = no medication; 1= use of dipyrone or paracetamol; 2= use of NSAIDs; 3= use of opiate derivatives; 4= routinely scheduled opiate derivatives), considering the last 48 hours.
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Isometric Peak Force
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To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Peak Force of hip flexors, abductors, adductors and extensors.
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Time to Reach Peak Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Time to Reach Peak Force of hip flexors, abductors, adductors and extensors.
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Change in Hip muscles Average Force
To examine isometric muscle force, a Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) will be used to access Average Force of hip flexors, abductors, adductors and extensors. We will also determine intra and inter-rater reliability for isometric force of hip flexors, abductors, adductors and extensors.
Time frame: Baseline, 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.
Evaluation of intra and inter-rater reliability of Lafayette Manual Muscle Testing System Model-01165 in subjects with hip Osteoarthritis.
To determine intra and inter-rater reliability of the Hand lend dynamometer Lafayette Manual Muscle Testing System Model-01165 (Lafayette Instrument Company, Lafayette IN, USA) in accessing peak force, time to reach peak force and average force of hip flexors, abductors, adductors and extensors, the first 20 participants included in this study will be evaluated by the principal investigator and outcome assessor at the baseline.
Time frame: Baseline
Change in Global Satisfaction
To evaluate participant satisfaction, we will use 5 points Likert Scale, ranging from 0 to 4 (0= none \_ no good at all, ineffective intervention; 1= poor \_ some effect but unsatisfactory; 2= fair \_ reasonable effect but could be better; 3= good \_ satisfactory effect with occasional episodes of pain or stiffness; 4= excellent \_ ideal response, virtually pain-free).
Time frame: 1 week, 12 weeks ± 1 week and 24 weeks ± 1 week.