Intra-articular botulinum toxin A injection for painful base-of-thumb osteoarthritis: a double-blind, randomised, controlled, phase 3 trial (RHIBOT).

BACKGROUND: Intra-articular botulinum toxin A injection might have analgesic effects in patients with joint diseases. We aimed to compare the effects of intra-articular botulinum toxin A injection with those of intra-articular saline injection for patients with painful base-of-thumb osteoarthritis. METHODS: RHIBOT was a double-blind, randomised, controlled, phase 3 trial conducted at Cochin Hospital, Paris, France. We recruited adult patients with x-ray evidence of trapeziometacarpal osteoarthritis who fulfilled the 1990 American College of Rheumatology criteria for hand osteoarthritis and reported a pain intensity score of at least 30 on an 11-point numeric rating scale (0: no pain to 100: maximal pain). Participants were randomly assigned (1:1), using a computer-generated randomisation list with permuted blocks of variable size (4 or 6), to receive an ultrasound-guided injection of either botulinum toxin A (50 Allergan units) in 1 mL of saline (experimental group) or 1 mL of saline alone (control group) in the trapeziometacarpal joint, in addition to custom-made rigid splinting. The primary outcome was the mean change from baseline in base-of-thumb pain in the previous 48 h on a numeric rating scale at 3 months after injection, analysed by intention to treat. This study is registered with ClinicalTrials.gov, NCT03187626. FINDINGS: Between Nov 2, 2018, and Nov 3, 2020, we assessed 370 individuals for eligibility and recruited 60 (16%) participants (mean age 64·9 years [SD 9·4], 47 [78%] women and 13 [22%] men), of whom 30 (50%) participants were randomly assigned to the experimental group and 30 (50%) to the control group. At baseline, base-of-thumb pain score was 60·0 of 100·0 (SD 15·9). At 3 months, the mean reduction in base-of-thumb pain was -25·7 (95% CI -35·5 to -15·8) in the experimental group and -9·7 (-17·1 to -2·2) in the control group (absolute difference -16·0 [-28·1 to -3·9]; p=0·043). Overall, 51 adverse events were reported in both groups: 27 (53%) in the experimental group and 24 (47%) in the control group. During follow-up, 14 (47%) participants in the experimental group and two (7%) participants in the control group reported mild transient motor deficit of the thenar muscle. No serious adverse events were reported. INTERPRETATION: Botulinum toxin A could be considered as a fast-acting, intra-articular therapy targeting chronic pain in individuals with base-of-thumb osteoarthritis. Future studies are needed to investigate the potential mechanism of the effects observed in this trial, to replicate our findings, and to assess the effects of repeated injections over time and their clinical effectiveness, including an analysis of cost-effectiveness. FUNDING: Assistance Publique-Hôpitaux de Paris.

Development of a new patient-reported outcome measure assessing activities and participation in people with lumbar spinal stenosis: The Cochin Spinal Stenosis 19-item questionnaire.

BACKGROUND: Lumbar spinal stenosis (LSS) is the leading cause of spinal surgery in people over 65-years old. In people with LSS, generic self-administered questionnaires are the most commonly used PROs to assess health-related quality of life, global activity limitation, and low back pain-located activity limitation. AIM: The aim was to develop a new patient-reported outcome measure assessing activities and participation in people with LSS. DESIGN: Observation, prospective and qualitative study. SETTING: For the qualitative study, were enrolled in- and outpatients with LSS from 2 French tertiary care centers (Department of PRM of Cochin Hospital and Department of Rheumatology of Limoges Hospital). For the Internet E-survey, screened the electronic medical records of the Department of PRM of Cochin Hospital. POPULATION: From February to April 2018 were enrolled patients older than 50-years and symptomatic LSS. METHODS: We used a 2-step approach. In a first step, we conducted a qualitative study using in-depth semi-structured interviews in 20 patients with LSS to collect meaningful concepts and to develop a provisional questionnaire. In a second step, using the provisional questionnaire, we conducted an Internet E-survey in an independent sample of 200 patients with LSS. RESULTS: Concepts collected from patients generated a 48-item provisional questionnaire. Overall, 63/200 (31.5%) patients completed the provisional questionnaire. Item reduction resulted in a 19-item questionnaire, the Cochin Spinal Stenosis 19-item (CSS-19) questionnaire. Principal component analysis extracted 3 factors. In confirmatory analysis, factor 1 influenced all items. We found convergent validity with low back pain, LSS-specific disability and divergent validity with mental health-related quality of life. Cronbach α coefficient (95% CI) was 0.96 (0.94; 0.97). ICC was 0.90 (0.70; 0.97). Bland and Altman analysis found no systematic trend for test-retest. CONCLUSIONS: CSS-19 is a new patient-reported outcome measure assessing activities and participation in people with LSS. Its construction prioritized patients' perspectives at all stages. Its content and construct validities are good. CLINICAL REHABILITATION IMPACT: Instruments able to capture specific needs of people with LSS in terms of activities and participation are lacking.

Evaluation of short-term efficacy of extraspinal cementoplasty for bone metastasis: A monocenter study of 31 patients.

OBJECTIVE: To study the effect on pain of per-cutaneous cementoplasty for painful extraspinal bone metastasis. METHOD: 43 patients with extraspinal bone metastasis were included between April 2006 and October 2014 in this retrospective monocenter study. The primary endpoint was pain level measured on a 0-10 numeric rating scale at week 1 after cementoplasty as compared with pre-cementoplasty. Secondary endpoints were long-term pain level and impact on quality of life and disability. RESULTS: Mean pain score was 4.2 (SD ±3.6) before cementoplasty and 1.09 (SD ±2.4) at week 1 (p = 0.005) (n = 31 patients). At 22 months after cementoplasty, quality of life and disability improved (according to the patient global assessment) for 47.6% and 52.2% of patients (n = 21patients). We did not find a predictor of good response. Cement leakage was the most common adverse event. CONCLUSION: Percutaneous cementoplasty of extraspinal bone metastasis is a rapidly efficient treatment with few adverse events. Its efficacy persists over time, with a benefit for disability and quality of life. Although this technique is only palliative, it should be considered in this situation.