Frozen Shoulder: A Pragmatic Replicated N-of-1 Case Series Investigating Glucose Levels and Patient Reported Outcomes Following a Corticosteroid Injection.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 10
- 主要终点
- Mean glucose levels
研究概览
简要总结
The goal of this clinical study is to look at what happens to blood sugar levels in people who have a frozen shoulder, who do not have diabetes after a corticosteroid injection in people with frozen shoulder.
- The primary aim of this study will be to evaluate alterations in glucose levels for people without diabetes, following corticosteroid injection for frozen shoulder.
- The secondary aims are to observe a range of clinical, physiological, and psychosocial outcomes following corticosteroid injection for people with frozen shoulder.
Participants will wear a glucose measuring device, attached to the upper arm collecting readings of glucose levels for 14 days.
Participants will undergo a corticosteroid injection as part of usual care.
详细描述
Frozen shoulder is regarded one of the most painful conditions to affect the shoulder. It is associated with substantial and prolonged pain that affects sleep and permeates into every aspect of daily function. Epidemiological research suggests the average onset is in the 6th decade, affecting up to 8% of men and 10% of women of working age may be affected. In people with diabetes this figure dramatically increases, with the incidence of frozen shoulder ranging from 10 to 59%.
Injection for frozen shoulder is a well-established treatment option, particularly in the early phase of the condition. The aim of this study is to assess glycaemic changes in a non-diabetic population following a corticosteroid injection. The cardiovascular risk factors associated with developing diabetes, which are increasing globally, because of ageing, smoking, poor diet and lack of physical activity, means there is good reason to understand better the impact of injection for frozen shoulder on the normo-glycaemic population.
A continuous glucose monitor worn on the upper arm, will collect glucose data at multiple timepoints for the 14 days it is worn both before and following the injection. The device is minimally invasive with the use of a small electrochemical sensor inserted under the skin and takes readings of interstitial (between cells, just below the skin).
In the N-of-1 design the 'N' represents a single participant. This design bridges the gap between evidence-based research and clinical care in health conditions. N-of-1 studies are patient centred as participants become more involved in their condition and treatment, setting outcomes due to the close monitoring of participants. When the 'N' is repeated, this may make the findings more generalisable. The CONSORT guidelines for RCTs were extended and the CENT 15 guidelines for N-of-1 trials were developed. A strength of N-of-1 studies as they are focussed on the individual and whilst their comorbidities are stable, they can be included in the study.
For this study, an A-B-A phase design will be used. The initial phase (A) is where repeated glucose measures are automatically obtained via the sensor and uploaded to the website and to check participants glucose levels do not go to the hyper/hypoglycaemic ranges on the day of the injection.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 45 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged between 45 and 65
- •Without diabetes or pre-diabetes
- •Glenohumeral external rotation range is equally limited actively and passively by at least 50% compared to the contralateral side.
- •Other glenohumeral movements are equally limited actively and passively compared to the contralateral side in one or more additional planes of movement (such as hand behind the back/shoulder flexion/abduction/scaption).
- •The symptoms have been present for at least one month.
- •No significant abnormality on plain radiographs.
- •Ability to provide informed consent
排除标准
- •Aged 44 and under and 66 and over
- •People with frozen shoulder secondary to significant shoulder trauma (e.g., dislocation, fracture or full thickness tear requiring surgery) or other causes (e.g., recent breast cancer surgery or radiotherapy)
- •People with prediabetes, type 1 and 2 diabetes
- •A neurological disease affecting the shoulder
- •Evidence of other shoulder disorders (e.g., inflammatory arthritis, rotator cuff disorders, glenohumeral joint instability) or with red flags consistent with the criteria set out by British Elbow and Shoulder Society (Rangan, 2015).
- •Primary osteoarthritis of the glenohumeral joint on plain radiograph
- •Calcific tendinitis
- •Who have received corticosteroid injection for shoulder pain in the last 12 weeks
- •On long term steroids or a recent short course of oral steroids
- •Currently being treated with coumarin anticoagulants, such as warfarin
- •Who have participated in another research study involving an investigational medicinal product in the past 12 weeks
- •Significant renal or hepatic impairment
- •Any other significant disease which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study.
- •Systemically unwell or with infection
- •Pregnant or breastfeeding
结局指标
主要结局
Mean glucose levels
时间窗: 3 weeks
The primary biochemical outcome is mean glucose (mmol/dL) levels pre and post injection.
Shoulder Pain and Disability Index
时间窗: 3 weeks
The primary clinical outcome is the functional questionnaire 'Shoulder Pain and Disability Index' before and after the injection. The SPADI is a 13-item patient completed instrument. Its categories include "pain" (5 items) and "disability" (8 items), with the total score often described as a percentage, resulting from the summation of each component. Overall total scores range from 0 to 130 with a percentage score of 0 indicating less shoulder disability and 100 indicating more shoulder dysfunction.
次要结局
- Pain Self Efficacy Questionnaire(3 weeks)
- Pittsburgh Sleep Quality Index(3 weeks)
- Quick Disabilities of the Arm, Shoulder, and Hand(3 weeks)
- Time in glucose range %(3 weeks)