Dataset Information

A comparison between acupotomy vs the local steroid injection for the management of soft tissue disorder: A systematic review protocol.

ABSTRACT:

Background

This systematic review protocol aims to provide the methods used to evaluate the effectiveness of acupotomy therapy for treating soft tissue disorder comparing to local steroid injection.

Methods

Fifteen databases will be searched from inception to Dec 2019. We will include randomized controlled trials (RCTs) assessing acupotomy for soft tissue disorder. All RCTs on acupotomy or related interventions will be included. Study inclusion, data extraction and quality assessment will be performed independently by two reviewers. Assessment of risk of bias and data synthesis will be performed using RevMan 5.3 software. Cochrane criteria for risk-of-bias will be used to assess the methodological quality of the trials.

Results

This study will provide a high-quality synthesis of pain visual analog scale and functional disability or the quality of life, the success treatment rate, the recurrent rate, and the complications rate to assess the effectiveness and safety of acupotomy for soft tissue disorder patients compare to local steroid injection.

Conclusion

This systematic review will provide evidence to judge whether acupotomy is an effective intervention for patients with soft tissue disorder.

Prospero registration number

CRD42018109080.

SUBMITTER: Shen Y

PROVIDER: S-EPMC6855588 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Publications

A comparison between acupotomy vs the local steroid injection for the management of soft tissue disorder: A systematic review protocol.

Shen Yifeng Y Cai Tao T Li Ting T Zhong Juan J Guo Jing J Shen Huarui H

Medicine 20191101 45

<h4>Background</h4>This systematic review protocol aims to provide the methods used to evaluate the effectiveness of acupotomy therapy for treating soft tissue disorder comparing to local steroid injection.<h4>Methods</h4>Fifteen databases will be searched from inception to Dec 2019. We will include randomized controlled trials (RCTs) assessing acupotomy for soft tissue disorder. All RCTs on acupotomy or related interventions will be included. Study inclusion, data extraction and quality assessm ...[more]

PMID: 31702675

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Project description:Background and Objectives: This pilot study aimed to evaluate the clinical effectiveness, cost-effectiveness, and safety of acupotomy combined with epidural steroid injection (ESI) in lumbosacral radiculopathy and examine its feasibility for the main study. Materials and Methods: This randomized, controlled, two-arm, parallel, assessor-blinded, pragmatic study included 50 patients with severe lumbosacral radiculopathy who had insufficient improvement after an ESI. Patients were randomized (1:1 ratio) into a combined treatment (acupotomy + ESI, experimental) and an ESI single treatment (control) group. Both groups underwent a total of two ESIs once every 2 weeks; the experimental group received eight additional acupotomy treatments twice a week for 4 weeks. Types of ESI included interlaminar, transforaminal, and caudal approaches. Drugs used in ESI comprised a 5-10 mL mixture of dexamethasone sodium phosphate (2.5 mg), mepivacaine (0.3%), and hyaluronidase (1500 IU). The primary outcome was the difference in changes from baseline in the Oswestry Disability Index (ODI) scores between the groups at weeks 4 and 8. The incremental cost-utility ratio (ICUR) was calculated to evaluate the cost-effectiveness between the groups. Adverse events (AEs) were assessed at all visits. Results: Mean ODI scores for the experimental and control groups were -9.44 (95% confidence interval [CI]: -12.71, -6.17) and -2.16 (95% CI: -5.01, 0.69) at week 4, and -9.04 (95% CI: -12.09, -5.99) and -4.76 (95% CI: -7.68, -1.84) at week 8, respectively. The difference in ODI score changes was significant between the groups at week 4 (p = 0.0021). The ICUR of the experimental group versus the control group was as economical as 18,267,754 won/quality-adjusted life years. No serious AEs were observed. Conclusions: These results demonstrate the potential clinical effectiveness and cost-effectiveness of acupotomy combined with ESI for lumbosacral radiculopathy and its feasibility for a full-scale study. Larger, long-term follow-up clinical trials are needed to confirm these findings.

Project description: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 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.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 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.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 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 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.

Project description:ImportanceLocal steroid injection is commonly used in treating patients with idiopathic carpal tunnel syndrome, but evidence regarding long-term efficacy is lacking.ObjectiveTo assess the long-term treatment effects of local steroid injection for carpal tunnel syndrome.Design, setting, and participantsThis exploratory 5-year extended follow-up of a double-blind, placebo-controlled randomized clinical trial was conducted from November 2008 to March 2012 at a university hospital orthopedic department. Participants included patients aged 22 to 69 years with primary idiopathic carpal tunnel syndrome and no prior treatment with local steroid injections. Data were analyzed from May 2018 to August 2018.InterventionsPatients were randomized to injection of 80 mg methylprednisolone, 40 mg methylprednisolone, or saline.Main outcomes and measuresThe coprimary outcomes were the symptom severity score and rate of subsequent carpal tunnel release surgery on the study hand at 5 years. Secondary outcomes were time from injection to surgical treatment, SF-36 bodily pain score, and score on the 11-item disabilities of the arm, shoulder, and hand scale.ResultsA total of 111 participants (mean [SD] age at follow-up, 52.9 [11.6] years; 81 [73.0%] women and 30 [27.0%] men) were randomized, with 37 in the 80 mg methylprednisolone group, 37 in the 40 mg methylprednisolone group, and 37 in the saline placebo group. Complete 5-year follow-up data were obtained from all 111 participants with no dropouts (100% follow-up). At baseline, mean (SD) symptom severity scores were 2.93 (0.85) in the 80 mg methylprednisolone group, 3.13 (0.70) in the 40 mg methylprednisolone group, and 3.18 (0.75) in the placebo group, and at the 5-year follow up, mean (SD) symptom severity scores were 1.51 (0.66) in the 80 mg methylprednisolone group, 1.59 (0.63) in the 40 mg methylprednisolone group, and 1.67 (0.74) in the placebo group. Compared with placebo, there was no significant difference in mean change in symptom severity score from baseline to 5 years for the 80 mg methylprednisolone group (0.14 [95%CI, -0.17 to 0.45]) or the 40 mg methylprednisolone group (0.12 [95%CI, -0.19 to 0.43]). After injection, subsequent surgical treatment on the study hand was performed in 31 participants (83.8%) in the 80 mg methylprednisolone group, 34 participants (91.9%) in the 40 mg methylprednisolone group, and 36 participants (97.3%) in the placebo group; the number of participants who underwent surgical treatment between the 1-year and 5-year follow-ups was 4 participants (10.8%) in the 80 mg methylprednisolone group, 4 participants (10.8%) in the 40 mg methylprednisolone group, and 2 participants (5.4%) in the placebo group. All surgical procedures were conducted while participants and investigators were blinded to type of injection received. The mean (SD) time from injection to surgery was 180 (121) days in the 80 mg methylprednisolone group, 185 (125) days in the 40 mg methylprednisolone group, and 121 (88) days in the placebo group. Kaplan-Meier survival curves showed statistically significant difference in time to surgical treatment (log-rank test: 80 mg methylprednisolone vs placebo, P = .002 ; 40 mg methylprednisolone vs placebo, P = .02; methylprednisolone 80 mg vs 40 mg, P = .37).Conclusions and relevanceThese findings suggest that in idiopathic carpal tunnel syndrome, local methylprednisolone injection resulted in statistically significant reduction in surgery rates and delay in need for surgery.Trial registrationClinicalTrials.gov Identifiers: NCT00806871 and NCT02652390.

Project description:IntroductionWith the increasing use of intravitreal administration of corticosteroids in macular edema, steroid-induced intraocular pressure (IOP) rise is becoming an emergent issue. However, for patients in whom intravitreal steroids are indicated, there are no specific recommendations for IOP monitoring and management after intravitreal administration of corticosteroids.MethodAn expert panel of European ophthalmologists reviewed evidence on corticosteroid-induced IOP elevation. The objective of the panel was to propose an algorithm based on available literature and their own experience for the monitoring and management of corticosteroid-induced IOP elevation, with a focus on diabetic patients.ResultsData from trials including diabetic patients with a rise of IOP after intravitreal steroid administration indicate that IOP-lowering medical treatment is sufficient for a large majority of patients; only a small percentage underwent laser trabeculoplasty or filtering filtration surgery. A 2-step algorithm is proposed that is based on the basal value of IOP and evidence for glaucoma. The first step is a risk stratification before treatment. Patients normotensive at baseline (IOP ≤ 21 mmHg), do not require additional baseline diagnostic tests. However, patients with baseline ocular hypertension (OHT) (IOP > 21 mmHg) should undergo baseline imaging and visual field testing. The second step describes monitoring and treatment after steroid administration. During follow-up, patients developing OHT should have baseline and periodical imaging and visual field testing; IOP-lowering treatment is proposed only if IOP is >25 mmHg or if diagnostic tests suggest developing glaucoma.ConclusionThe management and follow-up of OHT following intravitreal corticosteroid injection is similar to that of primary OHT. If OHT develops, IOP is controlled in a large proportion of patients with standard IOP treatments. The present algorithm was developed to assist ophthalmologists with guiding principles in the management of corticosteroid-induced IOP elevation.FundingAlimera Sciences Limited.

Dataset Information

A comparison between acupotomy vs the local steroid injection for the management of soft tissue disorder: A systematic review protocol.

Background

Methods

Results

Conclusion

Prospero registration number

Publications

A comparison between acupotomy vs the local steroid injection for the management of soft tissue disorder: A systematic review protocol.

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