Shock Wave Therapy, Associated to Eccentric Strengthening Versus Isolated Eccentric Strengthening for Treating Insertional Achilles Tendinopathy: Double Blinded Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- VISA-A Score change
研究概览
简要总结
Background: There is no consensus regarding the treatment of insertional tendinopathies. The good results of the eccentric training in the management of the non-insertional Achilles tendinopathy were not reproducible in the insertional disease. Shock wave therapy is described as an alternative to these patients.
Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents better results that the eccentric strengthening associated to placebo.
Design: Double blinded (outcome assessor and patient) randomized clinical trial, with the use of placebo, in parallel groups.
Materials and Methods: Nine-three patients with chronic insertional tendinopathy will be enrolled in a randomized trial. Participants will be divided in two groups, one containing the combination of shock wave and eccentric exercises as treatment and the other comprehending the exercises assembled to placebo. The assessment of outcomes will occur in 2, 4, 6, 12 and 24 weeks of the beginning of the study. Patients will be evaluated for pain, activity and function by the VISA-A (the Victorian Institute of Sport Assessment-Achilles [VISA-A] questionnaire).
详细描述
Introduction: The insertional tendinopathy occurs in the Achilles attachment to the tuberosity of the calcaneus bone and up to 2 cm proximal to the tuberosity. It is generally associated to a traction enthesophyte (upper spur), to Haglund deformity (pump bump) and to pre and retro achilles bursitis. Nowadays, it is considered that its cause is multi-factorial, comprehending mechanical, vascular, neural and genetic factors. Historically, the disease´s initial treatment is based on motor physiotherapy, via the eccentric strengthening of the tendon. If, on the one hand, the results for non-insertional tendinopathy were encouraging, 82% of them being duly successful, the insertional tendinopathy, on the other hand, produced a rate of improvement ranging between 32 and 67% of the patients, according to the present studies.
The failure of the traditional treatment normally leads the patients to surgery frequently associated to complications, such as wound necrosis and tendon rupture. More recently, the therapy with shock waves is being used in the treatment of pseudo-arthrosis and several types of tendinopathy.
Several studies showed the above mentioned effects of the shock wave therapy may theoretically stimulate neovascularization and of the collagen production that, besides being important in the healing process, also permits several clinical usages, such as the skin healing treatment, the pseudo-arthrosis and several tendinopathies, including the Achilles insertional tendinopathy. The shock wave therapy is being progressively more studied. Recent works have presented good results with the technique however; the evidences are still insufficient to represent a consensus regarding the indication of this treatment.
The objective of the present study is compare the effectiveness of eccentric strengthening protocol with and without shockwave therapy considering the VISA-A.
Hypothesis: The shock wave therapy allied to the eccentric strengthening protocol presents better results that the eccentric strengthening associated to placebo.
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, Investigator, Outcomes Assessor)
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
- •Older than 18 and younger than 65 years of age, both genders;
- •Pain symptoms in the calcaneus tendon insertion region over the last three months;
- •Clinical diagnosis: presence of pain at palpation of the tendinous insertion region in the calcaneus bone (and up to 2cm close to this region) and the occurrence of increase of the region´s volume;
- •Indication of tendinopathy in the Ultra Sound done at the previous health center or by a certified doctor;
- •Lateral X-ray view of the calcaneus, showing any of the associated conditions (Haglund, enthesophyte or intra-substantial calcification).
排除标准
- •Previous surgery involving the affected foot or ankle; History or documented evidence of autoimmune or peripheral vascular diseases;
- •History or documented evidence of peripheral neuropathy (nervous compression syndrome, tarsal tunnel syndrome).
- •History or documented evidence of systemic inflammatory disease a (rheumatoid arthritis, spondylitis, Reiter Syndrome, etc.)
- •History or documented evidence of loss of sensibility in the foot or ankle;
- •Non-Insertional or mixed tendinopathy (insertional and non-insertional);
- •Previous infiltration in the affected tendon over the six months preceding the initial assessment;
- •Beginning of the present pain, due to a trauma;
- •Gross or congenital deformity overweighting the triceps sural muscle, being the main aetiology of the present disease.
- •Pregnancy;
- •Any condition that represents a contraindication of the proposed therapies;
- •Any physical or social limitation that makes the protocol continuation unviable;
- •Impossibility or incapacity to sign the Free Informed Consent Form;
- •History or documented evidence concerning the blood coagulation disorders (treatment with anti-coagulant, excluding aspirin);
- •Use of heart pacemaker;
- •Presence of infectious process (superficial on skin and cellular tissue, or deep in the bone) in the region to be treated;
- •Non-palpable anterior or posterior tibial pulse; or abnormal capillary filling;
- •Tumour lesions (primary or secondary tumours).
结局指标
主要结局
VISA-A Score change
时间窗: 0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks
Victorian Institute of Sports Assessment - Achilles
次要结局
- VAS - Pain assessment (change)(0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks)
- VAS with 3kg of pressure in the Algometer (change)(0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks)
- AOFAS Hindfoot Scale (change)(0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks)
- Pain threshold at Algometry (change)(0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks)
- SF-12 (change)(0 - 2 weeks - 4 weeks - 6 weeks - 12 weeks - 24 weeks)
研究者
Nacime Salomão Barbachan Mansur
Medical Doctor
Federal University of São Paulo