Evaluation of Effectiveness of Selected Physical and Kinesiotherapeutic Methods in Patients With Lower Calcaneal Spur
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- The SF-36v2 Health Survey (SF-36v2) - Change
研究概览
简要总结
This study evaluates the effectiveness of physiotherapy and kinesiotherapy in patients with calcaneal spurs. the aim of the study is to compare the efficacy of calcaneal spurs treatment provided with extracorporeal shock wave therapy, ultrasound therapy, electric field diathermy associated with kinesiotherapy and sham laser in combination with kinesiotherapy. In each group kinesiotherapy treatment is the same and consists of an eight-minute massage of posterior lower leg muscles and plantar aponeurosis stretching.
详细描述
Number of 120 diagnosed with heel spur patients, will be allocated randomly into one of three treatment groups or into the control group. Assignment to a group is random, but before that happens patients will be questioned about inclusion and exclusion criteria of the study. Depending on group allocation, patients in treatment groups will receive one of the following physical therapy treatments:
- ESWT (once a week for 10 weeks)
- ultrasound (three times a week for 5 weeks)
- electric field diathermy (three times a week for 5 weeks).
Patients allocated in control group, will receive a sham laser therapy (only the timer on the machine activated) three times a week for 5 weeks.
Regardless of affiliation to the group, each patient will also receive kinesiotherapy treatment.
At the beginning of the study, each patient receives the "Information for the patient," describing the exact course of each stage of the study, then signs a "Form of informed consent to participate in the study.". The next stage of the study is to fill in the participant survey questionnaire and physical examination provided by the researcher.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 40 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •heel spur (calcaneal spur) diagnosed by a doctor based on X-ray examination, diagnostic ultrasonography or MR
- •signed informed consent
- •heel pain for at least one month
排除标准
- •pregnancy
- •generalized acute infection (fever, cough, runny nose)
- •local infection in the treated leg (wound, swelling)
- •injections of corticosteroids in the last six weeks
- •pacemaker
- •acute inflammation of the joints of the lower limbs
- •inflammation of the veins
- •Fresh fractures, post-traumatic
- •osteoporosis
- •Reynaud's disease
- •Burger disease
- •atherosclerosis
- •after surgery condition before removing stitches
- •High blood pressure
- •after CT with contrast condition in the last two weeks
- •The state of the lumbar puncture
- •Strong imbalance
- •Condition after myocardial infarction in the last six weeks
- •Rheumatoid arthritis
- •Ankylosing spondylitis
- •Significant leg ulcers
- •The risk of bleeding in the muscle tissue
- •Thromboangiitis
- •Hypersensitivity skin in the treated section
- •A tendency to hemorrhage
- •Pathological arrogance bone under the skin in the treated section
- •Metal implants and surgical implants in the area of the lower limb subjected to therapy
结局指标
主要结局
The SF-36v2 Health Survey (SF-36v2) - Change
时间窗: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The SF-36v2 Health Survey is a multipurpose, short-form health survey with 36 questions that yields an eight-scale profile of functional health and well-being, as well as two psychometrically based physical and mental health summary measures and a preference-based health utility index. Like its predecessor, the SF-36 Health Survey , the SF-36v2 is a generic measure of health status, as opposed to one that targets a specific age, disease, or treatment group. It has proven useful for conducting surveys of general and specific populations, comparing the relative burden of diseases, and differentiating the health benefits produced by a wide range of treatments.
The American Orthopedic Foot and Ankle Society Score (AOFAS) - Change
时间窗: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The American Orthopedic Foot and Ankle Society Score (AOFAS) is one of most widely used clinician-reporting tools for foot and ankle conditions. Developed in 1994, it is a clinician-based score that measures outcomes for four different anatomic regions of the foot: The ankle-hindfoot, midfoot, metatarsophalangeal (MTP)-interphalangeal (IP) for the hallux, and MTP-IP for the lesser toes. The four anatomic regions of the AOFAS are all represented by a different version of the survey with each tool designed to be used independently. The questionnaire consists of nine items that are distributed over three categories: Pain (40 points), function (50 points) and alignment (10 points). These are all scored together for a total of 100 points.
The Laitinen Pain Indicator Questionnaire
时间窗: Change from before the treatment and right after the treatment. Also change from after the treatment at 2 months.
The Laitinen Pain Indicator Questionnaire is subjective and point tool which is used to assess the level of pain. Patients have to evaluate four indicators: pain intensity, the frequency of pain, the frequency of use of analgesics and physical activity limitations. Each indicator score is assigned from 0 to 4, with 0 being no problem, and four being a maximum problem.
次要结局
- Two weights test(Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.)
- Heel standing test(Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.)
- The Visual Analogue Scale(Patients will be screened using this scale three times: before treatment, immediately after its completion and two months after the end of therapy.)
研究者
Natalia Kociuga
Master of Physical Therapy
Medical University of Lodz