Acupuncture for the Treatment of Phantom Limb Syndrome: A Randomised Controlled Trial (Feasibility Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in Numerical Rating Scale
研究概览
简要总结
The purpose of this study is to evaluate the feasibility and effectiveness of acupuncture for the treatment of phantom limb syndrome in lower limb amputees and pilot an acupuncture protocol. The study will be a comparative effectiveness study comparing acupuncture and standard care versus standard care alone and will be a randomised controlled trial using a mixed methods approach. The study hypothesis is a course of acupuncture will reduce the symptoms of phantom limb syndrome in lower limb amputees.
The study will be based the Amputee Rehabilitation Unit, London. Twenty lower limb amputees with phantom limb syndrome will be randomly assigned to either receive usual care or usual care plus acupuncture. Acupuncture intervention will include 8 treatments over 4 weeks and treatment will involve using both body and auricular acupuncture points. Usual care will include physiotherapy, occupational therapy, pharmacological intervention and other interventions as deemed appropriate by clinical staff.
An eleven point numerical rating scale will be the primary outcome measure in this study. Secondary outcome measures will include the Short Form McGill Pain Questionnaire 2, EQ-5D-5L, Hospital Anxiety and Depression Scale, Perceived Stress Scale, Insomnia Severity Index, Participant Global Impression of Change and information will also be obtained on rescue medication. A cheek swab will also be taken to explore potential subgroups of responders in relation to the genetic polymorphism of the glucocorticoid receptor. Outcomes will be recorded weekly for the duration of the study and one and three months post completion of the study. In order to identify protocol acceptability and acceptability of outcome measures five participants will be interviewed post completion of the study. Data will also inform feasibility such as recruitment rate, completion rate and reasons for dropout.
Data from this study will guide the development of a full randomised controlled trial.
详细描述
The feasibility study will be a comparative effectiveness study. A randomised controlled trial (RCT) using a mixed methods approach will be employed to evaluate the effect of acupuncture on phantom limb syndrome. The RCT will be an open pragmatic effectiveness trial, of parallel and fixed size design with usual care control. It will be unstratified, with balanced randomization (1:1). It will be conducted at the Amputee Rehabilitation Unit (ARU) at Lambeth Community Care Centre, London, UK. Quantitative data will be collected using standardised, validated outcome measures. Qualitative data will be collected post completion of the study through one to one semi-structured interviews.
Twenty participants will be approached and recruited whilst they are inpatients at the ARU. Those felt to meet the inclusion criteria will be identified by the key contact in the rehabilitation team. Potential participants will then be approached by the researcher, provided with verbal and written information about the study and be advised to take up to seven days to consider if they wish to participate in the study or not. No consent will be obtained at the time of providing information about the study.
Participants who consent to being involved in the study will be screened for eligibility and if eligible will be randomly assigned into either, usual care plus acupuncture (group A) or usual care only (group B). Randomisation and allocation concealment will be used to ensure against selection bias. A computer generated random numbers table will be used in this study and randomisation will be unstratified and balanced (1:1). Allocation concealment will be implemented using sequentially numbered, opaque, sealed envelopes. Randomisation and allocation concealment will be generated by a researcher not directly involved in the study.
As the study is pragmatic all groups will receive usual care. Usual care will include both medical intervention, physiotherapy / rehabilitation and any other intervention used at the ARU. Group A will receive usual care and a standard course of acupuncture (as already agreed with an expert panel of acupuncture practitioners). Group B will receive standard care only. The acupuncture intervention in this study will be pragmatic but strict guidelines will be adhered to within this pragmatic approach. These guidelines have been developed though current literature and a Delphi study with acupuncture practitioners and consists of some specific acupuncture points and points selected for that patient according to Chinese diagnosis. Acupuncture guidelines include:
- Using a combination of body and auricular acupuncture
- Treating the opposite limb to amputation and possibly also the residual limb
- Using auricular acupuncture points such as shen men, sympathetic, points corresponding to the lower limb
- Using body acupuncture points around the stump (depending on the health of the tissue and the patient), mirroring local and distal points by needling them on the opposite limb, and points on the lower back taking a segmental approach to dermatomal pain
- Including points such as; LI4 + LR3, LR3, GV20, SP10 and individual specific points according to specific symptoms
- Electro-acupuncture may be used
- Retaining needles for 20-30 minutes
- Treating twice weekly for four weeks
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age or above, full cognitive ability and able to communicate in English, able to provide informed consent and written informed consent obtained, current inpatients at the ARU (at time of enrolment), traumatic or medical amputation of a lower limb (greater than toes), currently experiencing phantom limb syndrome (with a verbal rating score of >4/10) in a lower limb.
排除标准
- •Less than 18 years of age, poorly controlled epilepsy, severe haemophilia or other bleeding / clotting disorders, pacemaker (if using electro-acupuncture), undergoing or recently undergone chemotherapy or bone marrow transplant, cognitive impairment and / or unable to give consent or communicate in English, medically unwell or severe other health complications (as advised by the medical consultant in charge of the participant), congenital limb absence, pregnancy, any skin changes or removal of lymph nodes on the body, ear or scalp that would preclude placement of acupuncture needles, needle phobia
结局指标
主要结局
Change in Numerical Rating Scale
时间窗: Change from baseline at four weeks
An eleven point scale will be used. The scale will present the numbers 0-10 with a description at 0 of 'no pain' and a description at 10 of 'pain as bad as you can imagine'. Participants will be asked to rate their average phantom pain over the last week
次要结局
- Patient Global Impression of Change (PGIC)(At four weeks)
- Change in Hospital Anxiety and Depression Scale (HADS)(Change from baseline at three months)
- Change in Short Form McGill Pain Questionnaire 2 (SF-MPQ-2)(Change from baseline at three months)
- Change in EQ-5D-5L(Change from baseline at three months)
- Change in The Insomnia Severity Index (ISI)(Change from baseline at three months)
- Change in Perceived Stress Scale (PSS)(Change from baseline at three months)
- Change in Numerical Rating Scale(Change from baseline at three months)