Rotator Cuff Tendinopathy: A Randomized and Blinded Comparison of Superficial and Deep Injection Methods
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- Change From Baseline of Visual Analog Pain Scale at 3 Months
研究概览
简要总结
HYPOTHESIS: Prolotherapy, the injection of a growth promoting solution in injured ligaments and tendons of the shoulder is an effective treatment that decreases pain, increases functional capacity and promotes healing better and in less time than standard treatment with physiotherapy.
OVERVIEW: 75 subjects with rotator cuff tendinopathy proven by ultrasound will be recruited and assigned randomly into one of three groups of 25 to receive one of these three different treatments:
Group A (test): 25% dextrose with 0.1% lidocaine, injected into the tendons and ligaments Group B (control): 0.1% lidocaine injected in the rotator cuff tendons and ligaments Group C(control): 0.1% lidocaine injected subcutaneously above these structures All subjects will receive physiotherapy every other week for three months. To avoid placebo effects, patients, the radiologist and physiotherapist will not know to which treatment group the patients belong; the physician administering the injections will not be involved in assessing disability before or after treatment. (Note: The physician will know which patients belong to group C because it will be obvious: they are delivering a subcutaneous - versus a joint - injection).
There will be three sets of injections - one set per month for 3 months. The patients' condition will be tracked for nine months after the first treatment, to monitor changes in 3 outcome measures: pain (VAS and Rx #s), function (DASH and PESS), and tendon healing (as assessed by ultrasound).
详细描述
SAMPLE SIZE: Sample size justification: Dr. Bertrand reviewed 144 cases treated with prolotherapy, 25 of whom fit the inclusion criteria (between the ages of 19 and 74 and not suffering from arthritis of the shoulder or from frozen shoulder). Among those patients, the difference between the pain score prior to treatment and that when they were given the questionnaire averaged 5.36 points over10 with a standard deviation of 3.28. Improvements from baseline to 6 months on the true placebo arm were projected to be about half those of the prolotherapy group, averaging 2.7 points of improvement with a standard deviation approximately equal to that of the prolotherapy group of 3.28. In order to achieve an 80% power of detecting the differences in mean improvements, given each group has a standard deviation of 3.3, and the average difference between groups is 2.7 points out of 10, each group should include 25 subjects.
RECRUITMENT AND CONSENT:
Recruitment: Ads were sent to all the North Shore and Burnaby physicians, physiotherapists, and chiropractors, posted in the Lions gate hospital ultrasound waiting room and North Shore recreation centers. A small adwords ad referred subjects to our website, www.prolotherapyhealing/shoulder.
Consent: At the initial appointment with Dr. Bertrand, the patient will be given information about the nature of this study and the procedures involved, including the fact that each of three treatments will consist of numerous shoulder injections. He will also be told that up to three monthly treatments may be needed to achieve relief from shoulder pain. If he decides to proceed, he will be given a copy of the consent form, the DASH questionnaire, and the VAS pain scale to fill out. The intake assessment includes socio-demographic information and medical history including the duration and severity of symptoms, smoking status, arm dominance and general health. If the patient manifests symptoms and signs of a rotator cuff tendinopathy which has lasted more than three months, and has no exclusion criteria, he will be scheduled for an ultrasound and an x-ray examination of the shoulder. The radiologist will rate the ultrasound using the USPRS. If no exclusion criteria are found, the patient will be referred to the physiotherapist for a baseline assessment of his shoulder using the (PESS), and scheduled for his first treatment session. The patient will be told to avoid all anti-inflammatory medications for the four weeks following each treatment. He will be given a prescription of Tylenol three or Tramacet as needed for pain control.
RANDOM ALLOCATION OF PATIENTS, AND STUDY GROUPS:
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
- Triple (Participant, Care Provider, Outcomes Assessor)
盲法说明
For the 25% dextrose and .1% lidocaine and the .1% lidocaine enthesis injections, only the pharmacist knew the contents of each participant's numbered bottle. For the .1% subcutaneous injections, both the pharmacist and the physician where aware of the contents. There was a small c on the label. Only one participant asked the meaning of this letter, and he was told it stood for "contents".
入排标准
- 年龄范围
- 19 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •consecutive patients over 19 and less than 75 years of age
排除标准
- •allergy to corn, as the dextrose solution is corn-based
- •allergy to local anesthetic
- •immune deficiency
- •conditions requiring anti-inflammatory medications including prednisone, corticosteroid injection less than eight weeks prior to the first set of injections
- •use of immune suppressants
- •symptomatic osteoarthritis of the gleno-humeral or acromio-clavicular joint
- •age over 75 or under 19
- •adhesive capsulitis based on a thorough physical examination, where shoulder flexion or abduction is below 100 °, horizontal adduction is below 30 °, the hand behind the back is below the waist, external rotation is less than 30 °
- •full thickness tear greater than 1.2 cm as seen on ultrasound
- •autoimmune disorders such as lupus or rheumatoid arthritis
- •neurological disorders including Parkinson, seizures, and dementias are excluded for patient safety during the procedures
- •HIV, viral hepatitis and other blood borne communicable diseases, to protect the investigators
- •calcium deposits greater than 8 mm in diameter
- •type III acromion as seen on x-ray
- •painful condition elsewhere in the body likely to cloud the subject's assessment of his shoulder pain
- •no evidence of tendinopathy as seen on ultrasound
- •uncontrolled diabetes: A1C > 7
研究组 & 干预措施
25% dextrose in shoulder entheses
25% dextrose and .1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).
干预措施: 25% dextrose in shoulder entheses (Procedure)
.1% lidocaine in shoulder entheses
.1% lidocaine injected in the shoulder entheses (ligament and tendon insertions on the periosteum).
干预措施: .1% lidocaine in shoulder entheses (Procedure)
.1% lidocaine subcu. above shouldr enth.
.1% lidocaine injected subcutaneously above the shoulder entheses (ligament and tendon insertions on the periosteum).
干预措施: .1% lidocaine subcu. above shouldr enth. (Procedure)
结局指标
主要结局
Change From Baseline of Visual Analog Pain Scale at 3 Months
时间窗: baseline and three months
Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 3 months. VAS scale is from 0 = no pain to 10 = maximum pain
Visual Analog Pain Scale 0= no Pain 10 = Maximum Pain
时间窗: 20 minutes before first injection on first day of patient visit
Subject marks his pain level at rest, at work, doing sports on a 10 cm scale. The maximum pain level among the 3 different activities was recorded.
Change From Baseline in Maximum Pain Score at 9 Months
时间窗: baseline and 9 months
Participants were asked about pain at rest, at work, doing sports. The maximum pain reported on a scale ranging from 0 (no pain at all) to 10 (extreme pain) was recorded for each participant. Maximum of pain scores rest, work, sport recorded. Calculated as pain at baseline - pain at 9 months.
次要结局
- Disabilities of the Arm Shoulder and Hand Questionnaire(20 minutes before the first injection and at 3 months)
- Rotator Cuff Ultrasound, Ultrasound Shoulder Pathology Rating Scale(20 minutes before first injection on first day of patient visit and at on average 9.4 months)
- Physical Examination of the Shoulder Scale(20 minutes before first injection on first day of patient visit and at 3 months)
- Nine Month Satisfaction Questionnaire(Nine months after first injection treatment appointment)
研究者
Helene Bertrand
M.D., C.M, CCFP
University of British Columbia