To study the Clinical outcomes of Vacuum IFT,Cryotherapy,Tecar or Laser Therapy combinations on patients with Spinal Ailments
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Pain Assessment:
研究概览
简要总结
This is a prospective study involves 100 patients with spine ailments undergoing physiotherapy treatments, including Vacuum IFT, Localized Cryotherapy, Laser Therapy, and TECAR Therapy. Patients will be randomly assigned to either a control or interventional group. The study aims to evaluate the effectiveness of combining these therapies to enhance pain management, functional recovery, and patient satisfaction. By determining the most effective therapy combinations, the study seeks to improve non-surgical treatment protocols for spinal disorders. The treatment phase will last 3-4 weeks, followed by a 1–2-month follow-up period to assess outcomes and patient satisfaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 95.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age 18-95 years.
- •2.Male and Female patients.
- •3.Pain duration greater than 3 months.
- •4.NPRS score greater or equal to
- •5.Diagnosed with: Postural problems Postural low back pain (LBP) Postural neck pain Trapezius muscle spasm Paraspinal muscle spasm Dorsal spine pain 6.Diagnosed by medical doctors or orthopaedic/spine surgeons.
- •7.Occupational spine ailments included.
- •8.Multivitamins permitted.
- •9.Willingness to participate and comply with the study protocol.
排除标准
- •Neuropathic pain due to nerve root compression.
- •Diabetes mellitus.
- •Severe comorbidity
- •History of acute trauma or fracture.
- •Implanted pacemakers.
- •History of malignancy or infection.
- •Systemic musculoskeletal disease.
- •Recent Spinal surgery (within the last 6 months)
- •Psychiatric disorders.
- •Neurodegenerative diseases.
- •Deep Vein Thrombosis (DVT).
- •Tuberculosis.
- •Spinal instability or deformities (PIVD, lumbar canal stenosis, scoliosis, cervical canal ste-nosis, lysis).
- •16.Diabetic neuropathy.
- •Osteoporosis.
- •Current use of NSAIDs or muscle relaxants.
结局指标
主要结局
Pain Assessment:
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Visual Analogue Scale (VAS)
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Numeric Pain Rating Scale (NPRS)
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
Disability and Functional Assessment:
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Modified Oswestry Disability Index (ODI)
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Roland Morris Disability Questionnaire
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Neck Disability Index (NDI)
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
Range of Motion (ROM):
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Lumbar flexion and extension
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Neck flexion and extension
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
Quality of Life Assessment:
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- SF-36 Health Survey
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
- Socioeconomic status via Kuppuswamy scale
时间窗: This is a prospective study involves a 3–4-week treatment phase and a 1–2-month follow-up period, requiring patient visits for data collection.
次要结局
- NA(NA)
研究者
Dr Akruti Dave
Stavya Spine Hospital and Research Institute