A Comparative Study of Two Dry Needling Interventions for Plantar Heel Pain: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Foot Health Status Questioner (FHSQ) PAIN
研究概览
简要总结
This is a clinical trial that will be done in the state of Kuwait, at the physical rehabilitation medicine hospital. the participants will be recruited from all over Kuwait, there is a clinical registry upon the ethical committee in Kuwait assigned by the ministry of health.
详细描述
Physical therapy approaches continue evolving. During the last years, minimally invasive techniques such as percutaneous needle electrolysis (PNE) was being developed, obtaining promising results for tendon pathology. PNE technique is a minimally invasive treatment that consists of an application of a galvanic electrolytic current that causes a controlled local inflammatory process in the target tissue. This allows for phagocytosis and the subsequent regeneration of the affected tissue. Nowadays, PNE is being used in clinical practice to manage MTrP, but there are no studies supporting that they have an additional beneficial effect over DN.
From a biological point of view, it seems reasonable to ascertain that a patient will obtain benefits thanks to the mechanical effects provided by the needle and that patients may benefit more if the electrolysis effect is added to the mechanical stimuli provided by the needle. Therefore, the aim of this randomized controlled study is to compare the effectiveness of DN versus PNE for the level of pain in patients suffering from PHP.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants who fulfill the inclusion criteria will receive the standardized oral and written information, and, once they consent to participate in the trial, will be randomized in a block system by blocks of 10 patients. Allocation to the groups will be achieved using a computer program (Randomizer, https://www.randomizer.org/) generated a random patient file numbers sequence by a third person not involved in the study from the file section in Kuwait. This person will be responsible for guarding the envelope with the information of the randomization. The envelopes will be closed until the moment of the intervention to maintain the blinding. This professional also will ask the patients for informed consent. The consent form is recruited upon the ethical medical committee at the ministry of health in the state of Kuwait.
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Clinical diagnosis of PHP in accordance with the Clinical Guidelines linked to the International Classification of Function, Disability, and Health from the Orthopedic Section of the American Physical Therapy Association
- •Age greater than 21 years according to the Kuwaiti law.
- •History of plantar heel pain for greater than one month.
- •Walking 50 meters without any support
- •Having MTPs on initial physical examination on plantar and calf muscles
- •Accepting to be treated by a male physiotherapist.
- •Capacity to understand the study and the informed consent, as well as having signed the document.
排除标准
- •- Needle phobia
- •Allergy from needles or hypersensitivity to metals
- •Presence of coagulopathy or use of anticoagulants
- •Presence of peripheral arterial vascular disease
- •Pregnancy
- •Dermatological disease with the dry needling area
- •The presence of a chronic medical condition that might preclude participation in the study such as malignancy, systemic inflammatory disorders (e.g. psoriatic arthritis, ankylosing spondylitis, septic arthritis), neurological diseases, polyneuropathy, mononeuropathy.
- •Treatment of plantar heel pain with needling or acupuncture during last 4 weeks.
- •A history of injection therapy in the heel in the previous three months.
- •Previous history of foot surgery or fracture.
结局指标
主要结局
Foot Health Status Questioner (FHSQ) PAIN
时间窗: Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks
Participants will complete the FHSQ at baseline and at 4, 8, 12, 26, and 52 weeks post-treatment. The FHSQ consists of 13 questions reflecting fourfoot health-related domains: pain (4 questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Individual item scores will then be re-coded, tabulated, and finally transformed to a scale ranging from 0 to 100 for each of the four domains. Greater scores reflect better foot health and quality of life. The FHSQ has been validated and has been used in similar trials that have evaluated the effectiveness of different interventions for plantar heel pain
次要结局
- VAS Maximum(1st session (baseline), 2nd session (week 2), 3rd session (week 3), 4th session (week 4))
- The Quality of Life (QoL) Will be Assessed With the EuroQoL-5 Dimensions (EQ-5D)(Baseline, 4 weeks, 8 weeks, 12 weeks, 26 weeks, 52 weeks")
研究者
ZAID AL BOLOUSHI
PhD student
Universidad de Zaragoza