A Double Blinded Randomized Controlled Trial (RCT) Exploring the Additional Effect of a Suprascapular Nerve Block in Combination With an Intra-Articular Corticosteroid Injection in Patients With Frozen Shoulder
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 110
- 试验地点
- 2
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
Frozen shoulder remains a challenging disease to treat as pain and loss of range of motion can persist for many months or even years. This loss of function can have a severe impact on the patient's activities, participation and overall quality of life.
The use of ultrasound-guided (USG) suprascapular nerve blocks (SSNB) and/or intra-articular corticoid injections (IACI) has been supported by many studies. However, double blinded randomized clinical trials using a combination of SSNB and IACI are rare.
The primary objective of this study is to compare the effectiveness of a glenohumeral IACI combined with a SSNB, compared to a glenohumeral IACI combined with a sham SSNB. Outcome measures of interest are shoulder-related disability reported by the patients, shoulder pain and shoulder stiffness. These outcome parameters will be compared between both treatment arms with an intention-to-treat analysis.
As key secondary objectives, the investigators aim to identify which physical examination tests, or combinations of those, are correlated with MRI diagnostic criteria and favor a more positive evolution. Finally, through predictive analysis the investigators will try to establish which patients benefit the most from the combined SSNB + IACI.
详细描述
Frozen Shoulder (FS) is common disease affecting 2 to 5% of the general population, with a higher prevalence in patients suffering from diabetes and thyroid dysfunction.It remains frustrating for patients and treating health care professionals as severe shoulder pain and loss of function can last for up to two years. 5-7 In the early stage, most patients identify the following symptoms: strong component of night pain, pain with rapid or unguarded movements and aggravated by movement or lying on the affected shoulder.8 Combined with marked pain and limitation in all directions of shoulder range of motion, it is easy to understand that suffering from Frozen Shoulder will have a detrimental effect on quality of life and the ability to perform activities of daily living.
The overall treatment aim for this condition is to "improve pain and function" and treatment goals should be set individually in a shared decision-making process. Patient education on the clinical course and different possible therapeutic interventions, including self-management strategies, should always come first. Clinicians should promote activity modification to utilize pain-free, functional ROM and stretching of the shoulder capsule matching the patient's current level of irritability.
Intra-articular corticosteroid injections (IACI) into the gleno-humeral (GH) joint, combined with shoulder mobility and stretching exercises, have shown to be more effective in providing short-term (4-6weeks) pain relief and improved function compared to exercises alone.
A recent article by Rex et al. places the results of the UK FROST trial in the context of 8 other randomized controlled trials comparing intra-articular corticoid injections (IACI) to manipulation under anesthesia (MUA), arthroscopic capsular release (ACR) and hydrodilatation. These findings did not show clinical superiority of either IACI, MUA nor ACR and evidence for hydrodilatation was inconclusive.
Common sense, in accordance with the National Institute of Health and Care Excellence (NICE) guidelines, recommends that treatments should be offered in a stepped approach from least to most invasive. In their systematic review from 2020, Challoumas et al. show that in the early phase of Frozen Shoulder IA corticosteroid is associated with better short-term outcomes, with possible benefits extending in the mid-terms. These authors recommend to associate IACI to education for home-based exercises and physiotherapy to increase the chances of resolution of symptoms by 6 months.
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)
盲法说明
All patients will receive 2 concomitant USG injections: first a SSNB than an IACA Control group : short-acting SSNB is performed with a short-acting local anesthetic (Linisol 2%).
Intervention group : SSNB is performed with a long-acting anesthestic (Ropivacaine 2%) + 20-mg methylprednisolone acetate.
Same injected volume (5ml) in sham and intervention group. The advantage of using a short-acting anesthetic as a sham injection instead of a saline, is that at the time of injection the patient may perceive the anticipated short effect of the anesthetic similar to the intervention SSNB.
The care provider will be unaware of the type of SSNB of the allocation group. The outcomes assessor will be unaware of the type of SSNB of the allocation group.
The investigator who administers the injections, will be unaware of the allocation.
The investigational products will be prepared by the pharmacist according to a pre-defined co-variate constrained randomization key.
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written informed consent to participate in the study must be obtained from the subject prior to initiation of any study-mandated procedure
- •Suffering from Frozen Shoulder, defined as: Frozen shoulder is a self-limiting disease characterized by pain and functional restriction in both active and passive shoulder motion lasting more than 1 month, for which radiographic findings of the shoulder joint are unremarkable.
- •Dutch or French speaking persons
- •Age ≥ 18 years
排除标准
- •Subjects with posttraumatic or postsurgical stiff shoulder syndrome
- •History of trauma at the onset of symptoms
- •Subjects with rheumatologic or neurologic disease involving the shoulder
- •Subjects with cervical radiculopathy
- •Coagulation disorder
- •Hypersensitivity to local anesthetics or MRI contrast agent
- •Inability to understand the study procedures
- •Psychiatric illness
- •Pregnancy
- •Subjects who have received prior SSNB in the homolateral shoulder
- •Subjects who have received an IACI in the homolateral shoulder in the 3 months before inclusion• Systematic yeast infections
- •Hypovolaemia
- •Infections at the injection site
- •Medical history of malignant hyperthermia, major conduction disorders, acute cardiac decompensation, shock conditions, convulsions
- •Control subjects for the diagnostic accuracy part of the study protocol
- •Inclusion criteria:
- •Written informed consent to participate in the study must be obtained from the sub-ject prior to initiation of any study-mandated procedure
- •Subjects suffering from shoulder pain that do not fulfill the diagnostic criteria of Frozen Shoulder
- •Dutch or French speaking persons
- •Age ≥ 18 years
- •Contralateral shoulder of Frozen Shoulder subjects
- •Exclusion criteria
- •Subjects with posttraumatic or postsurgical stiff shoulder syndrome
- •History of trauma at the onset of symptoms
- •Subjects with rheumatologic or neurologic disease involving the shoulder
- •Subjects with cervical radiculopathy
- •Coagulation disorder or treatments with anticoagulants
- •Hypersensitivity to MRI contrast agent
- •Inability to understand the study procedures
- •Psychiatric illness
- •Pregnancy
- •Systematic yeast infections
- •Hypovolaemia
- •Infections at the injection site
- •Medical history of malignant hyperthermia, major conductin disorders, acute cardi-ac decompensation, shock conditions, convulsions
研究组 & 干预措施
SSNB + IACI
Patients randomized to this arm will receive a SSNB (20-mg methylprednisolone acetate and 5-mL Ropivacaine 2mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml).
Rehabilitation/physiotherapy is considered standard of care.
干预措施: SSNB + IACI (Other)
Short-acting SSNB + IACI
Patients randomized to this arm will receive a SSNB (5-mL Linisol 10mg/ml) than a IACI (40-mg methylprednisolone acetate and 1-mL Ropivacaine 2mg/ml)
Rehabilitation/physiotherapy is considered standard of care.
干预措施: Sham SSNB + IACI (Other)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: 3 months
The Shoulder Pain and Disability Index (SPADI) is a self-administered index consisting of 13 items, divided into two subscales: 5 items for pain and 8 items for disability. It can be completed by patients in less than 5 min and has shown good reliability and construct validity in the assessment of shoulder impairments and in particular frozen shoulder. The score for each subscale is obtained by adding up all the individual subscale scores and dividing the result by the maximum subscale score. The normalized score is converted to a scale from 0 to 100, with 100 indicating no problems and 0 indicating serious problems.
次要结局
- Shoulder Pain and Disability Index (SPADI)(4 weeks- 6 months - 12months after the intervention)
- Shoulder ROM in abduction, anteflexion, external rotation(4weeks - 3 months - 6 months - 12 months after the intervention)
- Constant- Murley score (CMS)(4weeks - 3 months - 6 months - 12 months after the intervention)
- Work Status(4weeks - 3months - 6 months - 12 months after the intervention)
- Health care service use(4weeks - 3months - 6 months - 12 months after the intervention)
- Health related quality of life, evaluated with the EuroQol(4weeks - 3 months - 6 months - 12 months after the intervention)
- PROMIS-29 Upper Extremity v2.0(4weeks - 3 months - 6 months - 12 months after the intervention)
- Pain - Numeric Pain Rating Scale (NPRS)(4 weeks - 3 months - 6 months - 12months after the intervention)
- Global Rating of Change Score (GRoC)(4weeks - 3months - 6 months - 12 months after the intervention)
- Tampa Scale for Kinesiophobia (TSK-11):(4weeks - 3 months - 6 months - 12 months after the intervention)
- Pain Self-Efficacy Questionnaire (PSEQ)(4weeks - 3months - 6 months - 12 months after the intervention)
- Rescue therapy(3months - 6months - 12months after the intervention)
- Work Ability Index (WAI)(4weeks - 3months - 6 months - 12 months after the intervention)
- Adverse effects(4weeks - 3months - 6 months - 12 months after the intervention)