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临床试验/NCT04170166
NCT04170166Unknown不适用

Subacromial Injections for Shoulder Subacromial Pain Syndrome - Comparing Anterolateral Versus Posterior Approach: A Randomised Controlled Trial

Blackpool Teaching Hospitals NHS Foundation Trust2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2019年11月最近更新:
适应症

试验速览

阶段
不适用
入组人数
86
试验地点
2
主要终点
Oxford Shoulder Score

研究概览

简要总结

This study aims to determine if there is any difference in terms of pain relief in patients with shoulder subacromial pain syndrome, when given a steroid injection into the subacromial space via an anterolateral approach compared to a posterior approach.

详细描述

Patients who present with subacromial pain syndrome (disorders such as subacromial bursitis, rotator cuff tendinopathy, calcific tendinitis, subacromial inflammation with a partial thickness rotator cuff tear) to the orthopaedic outpatient clinic are treated initially with a subacromial steroid injection in addition to physiotherapy for a period of 3 months. This applies to patients who have had no other treatments previously as well as to patients who have had previous physiotherapy or steroid injections prior to presentation. Patients who do not want to undergo the treatment offered are either treated with simple analgesia, sole physiotherapy or surgery.

When a patient with one of the above conditions agrees to go ahead with a steroid injection followed by physiotherapy, the steroid injection is given at the earliest opportunity. The steroid injection is given into the subacromial space either using the anterolateral (front-side) approach (1 cm below and behind the anterior edge of the acromion with the needle aiming towards the under surface of the acromion) or using the posterior (back-side) approach ( 1cm inferior and medial to the posterlateral acromial edge with the needle pointing towards the anterolateral aspect of the acromion). The exact approach is determined according to the preference of the person carrying out the injection. As a routine we use a 10ml syringe containing 10mls of 0.25% Marcaine along with 40mg triamcinolone with an 18 gauge (green) needle. It is normal for patients to complain of some discomfort during the injection. If a patient experiences any significant discomfort or they cannot tolerate the injection for whatever reason, then the injection is discontinued and is not reattempted using a different approach.

Following the injection, patients are questioned on any discomfort experienced during the injection and on whether or not their pain has improved. They are then taken through a protocol of physiotherapy for their shoulder over the subsequent 3 months. A protocol is issued for guidance however therapists are allowed to use other modalities as per their discretion. The frequency of appointments with physiotherapy will depend on patient's symptoms as well as their progression. For study purposes a frequency record of these meetings will be kept and matched to the overall OSS. Patients are seen routinely in 3 months following an injection in order to assess any improvement in symptomatology using the OSS, visual analogue score, DASH and SF36 questionaires. If the symptoms have improved then no further intervention is taken. Further OSS, visual analogue pain score, DASH and SF36 questionaires will be posted out at 6 months and 1 year. On the other hand, if they are still troubled with symptoms then the possibility of further injections or surgery is discussed.

The aim of this study is to compare the two approaches that are currently used for subacromial steroid injections, namely the anterolateral and posterior approach, with regards to their effectiveness in improving shoulder symptoms. There will be no deviation from our routine protocol other than randomising patients who agree to participate in this study to either the anterolateral or posterior approach.

In summary, it is patients who are seen in clinic with a subacromial pathology and subsequently diagnosed with shoulder subacromial pain syndrome, who are offered an injection. Those who agree to have an injection will then be invited to participate in the study. An information leaflet will be given to all potential participants and they will be allowed sufficient time to read through it, digest all the information and ask any questions they may have before making a decision regarding their participation. Those who agree to participate will be randomly allocated, using sealed envelopes to one of the two approaches for the injection. The injection will then be administered via the selected approach by a clinician who is qualified in carrying out the procedure. Patients will be asked about any discomfort experienced during the injection, improvement in pain following the injection prior to leaving hospital and overall satisfaction with the injection. Following this patients will have physiotherapy as an outpatient as routine and will be seen at about 3 months post injection for a further assessment at the clinic. Again the shoulder assessment will be repeated on that occasion. Shoulder assessment questionaires will be posted out for completion at 6 months and 1 year (OSS, pain on visial analogue scale, DASH and SF36) There will be no change in patients care from routine practice other than the randomisation of the approach used for the injection. Patients who are invited to participate in the study and agree to participate will have their GP informed of their participation.

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

入选标准

  • Patient diagnosed with shoulder subacromial pain syndrome
  • Capacity to give valid consent for participation
  • Able to complete the follow up

排除标准

  • Age < 18
  • Lacking capacity/unable to give valid consent for participation
  • Full thickness rotator cuff tear diagnosed on either Ultrasound scan or Magnestic Resonance Imaging
  • Unable to complete follow up
  • Unable to speak or read English

结局指标

主要结局

Oxford Shoulder Score

时间窗: 3 months

The primary outcome measure will be the change in the Oxford Shoulder Score at 3 months post injection. Scores range from 0-48 with 48 being the best possible outcome.

次要结局

  • Oxford Shoulder Score(6 months and 1 year)
  • Pain on visual analogue scale(3 months, 6 months and 1 year post injection)
  • Disabilities of Arm, Shoulder and Hand Questionnaire(3 months, 6 months and 1 year)
  • Short Form 36 Health Survey Score(3 months, 6 months and 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Charalambos Charalambous

Consultant Orthopaedic Surgeon

Blackpool Teaching Hospitals NHS Foundation Trust

研究点 (2)

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