Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Visual Analog Pain Scale
研究概览
简要总结
In this study the investigators want to measure the impact or effects of adding cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in skin temperature above the injured tissues is presume to have a positive effect in the healing process. The combination of conservative care and cryostimulation could then be appreciated. The investigators chose to measure these effects with 3 elements: visual analog pain scale, validated elbow questionnaire and pain free grip strength. This pilot study consist in a two arm design, each arm including 15 patients.
详细描述
Lateral epicondylitis is one of the most prevalent upper limb conditions that can affect up to 1-3% of the active population. Invalidity and health care costs incurred by this condition are posing a real challenge to our societies knowing that the natural history of the lateral epicondylitis can last from 1 to 2 years. Many therapies have been tested and so far none has proven conclusive when used alone so far (Blanchette and Normand 2011). The use of cryostimulation is widespread in the sport scene without strong literature supporting its evidence. The aim of this study is to quantify the effects of cryostimulation when added to conservative care in the treatment of chronic lateral epicondylitis.
Thirty (30) patients will be divided randomly in two groups:
- The control group (n=15) will receive conservative care including myofascial trigger points (involved forearm) and radial head mobilisations (Bergmann & Peterson, 2010).
- The experimental group (n=15) will receive the cryostimulation and the conservative treatment as mentioned above.
A total of eight treatments will be given to each patient; the whole protocol lasting four to six weeks. The treatments will be delivered by experienced and trained clinicians in cryostimulation and myofascial treatment protocols.
The effects of the two treatment protocols will be monitored by a validated elbow questionnaire (PRTEE, (Rompe, Overend et al. 2007)), a visual analog pain scale and the pain free grip strength at three moments: at inclusion, at the ninth visit and 3 months after the last treatment.
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
- Single (Care Provider)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must have pain at lateral elbow (lateral epicondylitis) for at least six months
- •Pain must not come from trauma
- •Painful palpation of the lateral epicondyle
- •At least one out of two positive test: Cozen's, Mill's
排除标准
- •Fibromyalgia
- •Patient taking more than three medications at the time of inclusion
- •Cervical radiculopathy
- •Painful shoulder
- •Cold intolerance / allergies
- •Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion
研究组 & 干预措施
conservative care
this group of patients will receive the conservative care: myofascial point release and radial head mobilisation
干预措施: conservative care (Other)
cryostimulation
this group of patients will receive the conservative care :myofascial point release and radial haed mobilisation and the cryostimulation (30-40 second of cold air application (-70 celsius degree) in order to lower skin temperature around the lateral epicondyle at 4 celsius degree.
干预措施: cryostimulation (Device)
cryostimulation
this group of patients will receive the conservative care :myofascial point release and radial haed mobilisation and the cryostimulation (30-40 second of cold air application (-70 celsius degree) in order to lower skin temperature around the lateral epicondyle at 4 celsius degree.
干预措施: conservative care (Other)
结局指标
主要结局
Visual Analog Pain Scale
时间窗: at inclusion - ninth visit - 3 months after last treatment
Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10
次要结局
- pain free grip strength(at inclusion - ninth visit - 3 months after last treatment)
研究者
Nadia Richer
Nadia Richer, M.Sc., DC, clinician professor
Université du Québec à Trois-Rivières