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临床试验/NCT07402408
NCT07402408招募中不适用

Comparison of Band Tissue Flossing Method and Traditional Cuff Method for Blood Flow Restriction Training in Patients With Knee Osteoarthritis

Riphah International University1 个研究点 分布在 1 个国家目标入组 46 人开始时间: 2026年6月30日最近更新:
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
46
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

The aim of this study was to compare the effect of band tissue flossing method and traditional cuff method for blood flow restriction training on pain, range of motion, muscle strength and functional status in patients with knee osteoarthritis. Symptoms of this condition limit patient's ability to perform high load strengthening. Blood flow restraining training allows strengthening with lower loads. 46 subjects will be divided in two groups, 23 subjects in each group. knee extension and knee press exercises will be performed. In group A floss band was tied on thigh and in group B pneumatic cuff was applied on thigh. 40-60 years individual with knee osteoarthritis will be included. outcome measures will be assessed at baseline, after 1st session, after 2nd week and after 4th week.

详细描述

Osteoarthritis (OA) is a degenerative disorder affecting 528 million people worldwide. It occurs in individuals of age 40 years and above. Most affected joint is knee with prevalence of 60%-85% of total OA cases being 1.39 times higher in women than men. It is characterized by progressive damage to articular cartilage, leading to pain, stiffness, and reduced mobility negatively impacting function and quality of life of affected patients.

Obesity, low level of physical activity, joint overload, muscle imbalance in the knee joint, reduced weight and muscle strength in the lower limbs are the factors which can be modified. Quadriceps strengthening is considered as a first-line therapy making resistance training a common practice in OA management.

A useful alternative to high intensity exercises which are not tolerable by osteoarthritic patients is blood flow restriction (BFR) training. In BFR a cuff is applied around the proximal aspect of the affected limb, causing partial arterial and full venous occlusion, thereby inducing localized hypoxia and the accumulation of metabolites, imitating the effects of high load resistance training without using heavy load and higher repetition. BFR reduces pain along with improving muscle strength, and function in patients with osteoarthritis (OA) and rheumatoid arthritis.

The tissue flossing technique is also called BFR or Kaatsu training. The use of tissue flossing (TF) is a relatively recent treatment modality that gained popularity through the book by Starrett and Cordoza. The mechanisms involved in TF are similar to ischemic preconditioning or BFR training in which an application of an external pressure is used, above or below the muscle or joint, with the application of a tourniquet/inflatable cuff in the most proximal portion of the limb in the case of BFR or an elastic band. Tissue flossing can improve the range of motion or performance, speed up recovery, and decrease the pain caused by various diseases or injuries. The intervention consists of wrapping tissue flossing band around a body region (joint or soft-tissue) using a 50% overlapping in circumferential pattern (distal to proximal), with a relative stretch ranging from 50-75% of the band maximal length, and a treatment duration ranging from 2 minutes to 6 minutes or exercise repetition range from 10 to 30 repetitions.

In 2015, research evaluated effects of BFR on older women and concluded that addition of BFR with resistance training significantly increased leg press or quadriceps strength in older women.

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 (Participant)

入排标准

年龄范围
40 Years 至 60 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Age 40-60 years
  • Pain more than or equal to 3 on NPRS
  • Range of motion ≤ 100-degree flexion and ≤ 0-degree extension
  • Those who have knee osteoarthritis, according to KL (Grade 1 and 2)
  • Genders: Male and Female

排除标准

  • Cardiovascular condition e.g., hypertension, thromboembolism, lymphatic diseases etc.
  • Muscle/tendon/ ligament injuries
  • Any surgery, skin infection, trauma, pregnancy, fracture and fall
  • Patient with intra articular steroidal therapy with in last 6 months
  • Patient unwilling to participate and comply with the study session

研究组 & 干预措施

Blood flow restriction with Floss band (group A)

Experimental

seated knee extension and knee press while floss band is tied at proximal thigh.

干预措施: Blood flow restriction training with Floss band (Other)

Blood flow restriction with pneumatic cuff (group B)

Experimental

seated knee extension and knee press exercises with pneumatic cuff tied at proximal thigh

干预措施: Blood flow restriction training with pneumatic cuff (Other)

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: 4th week

Changes from baseline will be assessed using NPRS scale. It is a one-dimensional measure of pain severity in adults including those suffering from chronic pain. Scale has ratings of 0 to 10, with higher points indicating higher levels of pain severity. it is a valid tool for assessing pain in knee OA patients.

次要结局

  • Western Ontario and McMaster Universities (WOMAC) index(4th week)
  • 30 Second Sit to Stand Test (STS)(4th week)
  • Timed Up and Go Test (TUG)(4th week)
  • Knee Flexion Range of motion(4th week)
  • Knee Extension Range of Motion(4th week)
  • Quadriceps strength (dynamometer)(4th week)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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