A Randomised Controlled Double Blind Trial Of Therapeutic Ultrasound in Carpal Tunnel Syndrome (CTS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Boston/Levine subjective Symptom score
研究概览
简要总结
Carpal Tunnel Syndrome (CTS) is a recognisable pattern of symptoms and signs, which are caused by compression of the median (middle) nerve as it passes through the carpal tunnel at the wrist.
This condition affects individuals by causing pain, numbness, tingling sensations and sometimes weakness in the fingers and may extend to shoulder and neck areas. The cause for most cases is unknown (idiopathic) though some common conditions are associated with an increased incidence, including obesity, pregnancy, hypothyroidism, arthritis, diabetes, and trauma.
Diagnosis is primarily clinical and the condition is easily recognised from the characteristic symptoms in straightforward cases but diagnostic support is provided by investigations such as nerve conduction studies and ultrasound imaging.
Treatment may include splinting, local steroid injection at wrist, activity modification,physical or occupational therapy (controversial), medications, and surgery. Treatment with local therapeutic ultrasound has been suggested to be effective but existing trials are inconclusive.
Wrist splinting is only partially effective with a success rate of 34%, Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections. Surgery is effective but has a small but significant incidence of permanent complications. Any demonstrably effective and safe addition to the therapeutic options would be a significant advance in treatment. Therapeutic ultrasound at present appears a promising option, having a very good safety record but so far uncertain evidence of efficacy.
In our trial patients, with mild carpal tunnel syndrome, confirmed by nerve conduction studies, will all be given wrist splints so that no patients will be left untreated. They will be randomly allocated to either therapeutic or sham ultrasound therapy (20 sessions over 7 weeks) and followed up for 1year. The patients, operators of the ultrasound equipment and assessors will all be blind to treatment allocation.
The effect of treatment on symptoms will be assessed using a validated questionnaire and nerve conduction studies will be repeated at completion of the ultrasound treatment, 6 and 12 months.
This study is designed to find out to whether therapeutic ultrasound is an effective treatment for carpal tunnel syndrome (CTS).
详细描述
Carpal tunnel syndrome (CTS) is the commonest peripheral nerve disorder in the UK. Average annual incidences (per 100 000) were 139.4 for women and 67.2 for men in East Kent, UK.
It has significant economic impact, on average having the largest recuperation period of all injuries / illness that require days away from work. It causes tingling, numbness or pain in the distribution of the median nerve (the thumb, index, and middle fingers, and half the ring finger) that is often worse at night and causes wakening. The pathology of idiopathic CTS is a non-inflammatory fibrosis of the subsynovial connective tissue surrounding the flexor tendons but the causes are not fully understood.
Many treatments have been proposed but reviews performed by the Cochrane collaboration have found firm evidence in support of only:
- Surgical decompression of the carpal tunnel.
- Steroid therapy (local injection or systemic administration).
- Neutral angle wrist splinting.
None of the available evidence based treatments for CTS are entirely satisfactory. Splinting is only partially effective with a success rate of 34%, Steroid injection is followed by frequent relapses and there remains uncertainty about the safety of serial injections. Surgery results in a small but significant incidence of permanent morbidity from complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female participants aged between 18 and 90 years with mild carpal tunnel syndrome (Canterbury NCS grades 1-3).
- •No Previous treatment history other than splinting and use of over the counter NSAIDs.
排除标准
- •Subjects diagnosed with peripheral neuropathy, secondary entrapment neuropathies diabetes mellitus, rheumatoid disease, acute trauma.
- •Previous carpal tunnel surgery.
- •Pregnancy or lactating.
- •Patients with known HIV infection.
- •Other serious medical or psychiatric illness currently ongoing, or experienced within the past three months, that in the opinion of the investigator would compromise the study.
- •Patients unable to comply with the protocol requirements, including severe alcohol and drug use.
研究组 & 干预措施
Sham Ultrasound regimen
A switch in the transducer circuit allows mock ionisation as a result no ultrasound emitted.
干预措施: EMS Therasonic 460 Primo Ultrasound therapy (Device)
Real Ultrasound therapy
Pulsed mode ultrasound therapy
干预措施: EMS Therasonic 460 Primo Ultrasound therapy (Device)
结局指标
主要结局
Changes in Boston/Levine subjective Symptom score
时间窗: Baseline, 7th week, 6 months and end of 12months
Improvement in the Boston/Levine subjective Symptom score at completion of Ultrasound treatment(real or sham), a decrease of at least 1.04 points being considered a clinically significant change.
次要结局
- Functional status score(7th week, 6 months and end of 12 months)
- Nerve Conduction Studies(Baseline,7th week, 6 months and end of 12 months)
- Ultrasound Imaging of Wrist(s)(Baseline, 7th week, 6 and 12 months)
研究者
Kamalakannan Jothi
Highly Specialised Clinical Physiologist - Neurophysiology
East Kent Hospitals University NHS Foundation Trust