scholarly journals The SToICAL trial: study protocol for the soft tissue injection of corticosteroid and local anaesthetic trial—a single site, non-inferiority randomised control trial evaluating pain after soft tissue corticosteroid injections with and without local anaesthetic

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
M. Jones ◽  
J. Evans ◽  
S. Fullilove ◽  
E. Doyle ◽  
C. Gozzard

Abstract Background Corticosteroid injections are used in the treatment of hand and wrist conditions. The co-administration of a local anaesthetic and corticosteroid aims to reduce pain after the injection, although no studies have directly compared this with using corticosteroid alone. The aim is to determine whether pain experienced during the 24 h after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection. Methods A single-site, patient- and assessor-blinded, non-inferiority randomised control trial recording pain visual analogue scale (VAS) scores in patients with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome, treated with a 1-ml triamcinolone (40 mg/1 ml) injection co-administered with or without 1 ml of 1% lidocaine. The primary aim is to investigate a difference in pain VAS scores at 1 h after the injection using a mean change score. A 95% power calculation was made using a minimally clinical important difference of 20 mm as the clinically admissible margin of non-inferiority and an assumed standard deviation of 25 mm, from previous studies. Including a 20% fall out rate, 100 patients are required. Discussion Patients with a clinical diagnosis of trigger finger, de Quervains and carpal tunnel syndrome, are over the age 18 years old and who are able to give written informed consent will be included. Patients will be excluded if they have had previous surgery or corticosteroid injection for the condition being treated at the site considered for injection. Patients will be electronically randomised and injections delivered during their clinic appointment. Pain is assessed using a 100-mm VAS score taken, before and at the time of injection and at 5 min, 1 h, 2 h, 3 h and 24 h after the injection. The secondary outcomes are to determine a difference in pain VAS score at the time of injection and during the 24 h after. Trial registration This study is registered on the IRAS (259336) on November 11, 2019, and EudraCT database on October 31, 2019 (2019-003742-32). REC/HRA approval was given in January 2020, and Clinical Trial Authorisation from the MHRA was given in December 2019. The study is registered on ClinicalTrials.gov (NCT04253457) on February 5, 2020.

2021 ◽  
Author(s):  
Matt Jones ◽  
Jonathan Evans ◽  
Charles Gozzard ◽  
Sue Fullilove ◽  
Edmund Doyle

Abstract BackgroundCorticosteroid injections are used in the treatment of hand and wrist conditions. The co-administration of a local anaesthetic and corticosteroid aims to reduce pain after the injection, although no studies have directly compared this with using corticosteroid alone. The aim is to determine whether pain experienced during the 24 hours after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection. MethodsA single site, patient and assessor blinded, non-inferiority randomised control trial recording pain visual analogue scale (VAS) scores in patients with a clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome, treated with a 1ml Triamcinolone (40mg/1ml) injection co-administered with or without 1ml of 1% Lidocaine. The primary aim is to investigate a difference in pain VAS scores at 1-hour after the injection using a mean change score.A 95% power calculation was made using a minimally clinical important difference of 20mm as the clinically admissible margin of non-inferiority and an assumed standard deviation of 25mm, from previous studies. Including a 20% fall out rate, 100 patients are required. DiscussionPatients with a clinical diagnosis of trigger finger, de Quervains and carpal tunnel syndrome, are over the age 18 years old and who are able to give written informed consent will be included. Patients will be excluded if they have had previous surgery or corticosteroid injection for the condition being treated at the site considered for injection.Patients will be electronically randomised and injections delivered during their clinic appointment. Pain is assessed using a 100mm VAS score taken; before and at the time of injection, and at 5-minutes, 1-hour, 2-hours, 3-hours and 24-hours after the injection. The secondary outcomes are to determine a difference in pain VAS score at the time of injection and during the 24-hours after.Trial registrationThis study is registered on the IRAS (259336) on November 11, 2019 and EudraCT database on October 31, 2019 (2019-003742-32). REC/HRA approval was given in January 2020 and Clinical Trial Authorisation from the MHRA was given in December 2019. The study is registered on ClinicalTrials.gov (NCT04253457) on February 5, 2020.(https://clinicaltrials.gov/ct2/show/NCT04253457?term=stoical+study&draw=2&rank=1)


2012 ◽  
Vol 38 (6) ◽  
pp. 634-639 ◽  
Author(s):  
M. Berger ◽  
M. Vermeulen ◽  
J. H. T. M. Koelman ◽  
I. N. van Schaik ◽  
Y. B. W. E. M. Roos

The objective of this prospective study was to investigate the long-term effect of one or more local corticosteroid injections in patients with carpal tunnel syndrome and whether a good response can be predicted. Follow-up visits took place at 3 weeks, 6 months, and 1 year after the first corticosteroid injection. Thirty of the 120 patients (25%) had a good outcome with a single injection, 11 additional patients (9%) needed a second injection, and five patients (4%) needed a third injection to reach a good outcome after 1 year. Of patients with an initial good treatment response, 28 (52%) had a good outcome after 1 year compared with 18 (27 %) who had an initially moderate or no response to treatment. One-third of patients with carpal tunnel syndrome had a long-term beneficial effect from corticosteroid injection, especially when they had a good initial response.


Author(s):  
Yi-Chih Hsu ◽  
Fu-Chi Yang ◽  
Hsian-He Hsu ◽  
Guo-Shu Huang

Abstract Purpose Permanent nerve damage after corticosteroid injection has been suggested when symptoms of median nerve injury (MNI) are irreversible. We assess the outcomes of MNI and their association with ultrasonography (US)-guided hydrodissection and the following corticosteroid injection for symptomatic carpal tunnel syndrome (CTS). Methods US-guided hydrodissection and the following corticosteroid injections were administered to 126 CTS patients. Occurrence of MNI, clinical data, and post-hydrodissection findings were evaluated. Post-hydrodissection findings included vascular injury during hydrodissection, altered echogenicity, reduced flattening ratio, and increased cross-sectional area of the MN at the inlet of the carpal tunnel (MN-CSA-Inlet) on ultrasonography after hydrodissection. The relevance of MNI with respect to these clinical data and findings was determined. The outcome was rated using Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scores. Results Nine patients suffered MNI (incidence, 7.1 %) but improved significantly at follow-up. Clinical data and vascular injury during hydrodissection, altered echogenicity, and reduced flattening ratio after hydrodissection were unrelated to prolonged transient MNI (p > 0.05). MNI was significantly associated with increased CSA (p = 0.005). A CSA increase > 2 mm2 after hydrodissection yielded the greatest performance (0.979) for MNI in the receiver operating characteristic analysis. Decreases in BCTQ scores after injection did not differ significantly between groups with and without MNI (p > 0.05). Conclusion MNI during hydrodissection may be reversible. MNI is indicated by an increase in MN-CSA-inlet immediately after hydrodissection.


2018 ◽  
Vol 60 (3) ◽  
pp. 347-355
Author(s):  
Yi-Chih Hsu ◽  
Fu-Chi Yang ◽  
Hsian-He Hsu ◽  
Guo-Shu Huang

Background Corticosteroid injections are a popular technique for carpal tunnel syndrome (CTS) treatment and are believed to provide rapid symptom relief. Purpose To use magnetic resonance diffusion tensor imaging (MR-DTI) to determine the association between diffusion values of the median nerve (MN) at several anatomic locations and symptom relief in patients with CTS following corticosteroid injection. Material and Methods MR-DTI was performed on 15 wrists of 12 patients with CTS before and two weeks after ultrasound-guided corticosteroid injections. We recorded the patients’ clinical data including sex, age, side of injection, satisfaction, and symptom relief. Satisfaction and symptom relief were rated using a Likert scale and the Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) scale. Fractional anisotropy (FA) and apparent diffusion coefficient (ADC) of the MN at the levels of the distal radioulnar joint (DRUJ), pisiform bone, and hamate bone were determined. Results All patients had ≥50% satisfaction on the injection side. In comparison with baseline values, post-injection ADC was significantly lower ( P = 0.001) but FA was not significantly higher ( P = 0.11) at the pisiform bone level on the injected wrists. At the DRUJ and hamate bone levels, no obvious inter-scan change in FA and ADC ( P > 0.05) was observed. The decrease in ADC at the pisiform bone level strongly correlated with the decrease in BCTQ scores (r = 0.628; P = 0.012). Conclusion Symptom relief in patients with CTS receiving corticosteroid injection is related to the change in ADC of the median nerve at the level of the pisiform bone, as determined using MR-DTI.


2011 ◽  
Vol 44 (5) ◽  
pp. 763-768 ◽  
Author(s):  
Vera Meys ◽  
Sam Thissen ◽  
Stan Rozeman ◽  
Roy Beekman

2008 ◽  
Vol 62 ◽  
pp. 194-200 ◽  
Author(s):  
Nicolas M. Stütz ◽  
Andreas Gohritz ◽  
Alexander Novotny ◽  
Udo Falkenberg ◽  
Ulrich Lanz ◽  
...  

Author(s):  
Karen Walker-Bone ◽  
Benjamin Ellis

The forearm, hand, and wrist is a functionally vital part of the musculoskeletal system and in consequence, is highly sophisticated and complex in its anatomical development. Frequently, the hand and wrist may be the site of onset of symptoms of a polyarthropathy such as rheumatoid arthritis or of osteoarthritis, so that the physician should always seek to screen for such conditions before making a local diagnosis. Tenosynovitis, de Quervain’s disease, trigger digit, Dupuytren’s, and carpal tunnel syndrome are local soft tissue pathologies which can usually be discriminated on clinical grounds with or without the use of simple diagnostic tests and are satisfying to treat for the most part. Non-specific forearm pain is more complex, with much controversy surrounding not only its aetiopathogenesis but also its existence. It can be difficult to diagnose and difficult to treat.


Sign in / Sign up

Export Citation Format

Share Document