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临床试验/NCT07441044
NCT07441044已完成不适用

Comparative Effects of Graston With and Without Foot Insoles on Pain, Range of Motion and Functional Disability in Patients With Plantar Fasciitis

Riphah International University1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2025年1月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Numeric Pain Rating Scale (NPRS)

研究概览

简要总结

Plantar fasciitis is the most common causes of heel pain, especially in older adults. About 2 million people are treated for this specific disease every year. Plantar fascia is an Apo neurosis which maintains the arches on the plantar side of the foot. It runs all the way from tuberosity of calcaneal bone to heads of metatarsal bones. It consist of thick fibrous multi-layer connective tissue located on the planter side of the foot. Its inflammation is what is called plantar fasciitis. Plantar fasciitis has same pathophysiology as of tennis elbow at the foot, in which foot is exposed to repetitive micro trauma at your heel bone insertion of fascia. At night, foot usually adapt plantar flexed posture and after a long period of inactivity when patient touches ground after rising from bed, foot goes into dorsiflexion during walking.

详细描述

Numerous interventions have been utilized for treatment of plantar fasciitis, which include, heat, cryotherapy, non-steroidal anti-inflammatory drugs, heel pads/cups, night splints, Graston tool, foot insoles, low-dye arch taping, plantar fascia specific stretching, calf stretching, steroid injection, extracorporeal shock wave therapy, platelet-rich plasma injection,and myofascial trigger point therapy.

The study will investigate the combined effect of Graston and foot insoles in the patients with plantar fasciitis. Through a randomized control trial Group A will receive Graston technique and foot insole along with standard physical therapy. (Ice pack for 10 minutes, TENS, static stretching of calf muscles and plantar fascia, strengthening exercises for intrinsic foot muscles and Group B will only receive Graston technique and standard physical therapy. Findings from this study could pave for more comprehensive and effective care for patients with plantar fasciitis.

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 (Outcomes Assessor)

入排标准

年龄范围
30 Years 至 55 Years(Adult)
性别
All
接受健康志愿者
是

入选标准

  • •Patients experiencing pain and functional limitation in their plantar fascia
  • •Patients with a history of 6 weeks or more.
  • •NPRS 3 to 7
  • •≥ 2 degree calcaneous eversion
  • •Pain localized to medial calcaneal tuberosity
  • •Increase in heel pain on toe standing
  • •Positive windlass sign

排除标准

  • •• Patients will be excluded if they are diagnosed with the following conditions;
  • •Ankle sprain
  • •Any fracture
  • •Autoimmune disorder
  • •Congenital disorder
  • •Osteoarthritis
  • •Rheumatoid arthritis
  • •Structural deformity
  • •Patient who have undergone fascia release surgery within 3 months prior to study.

研究组 & 干预措施

Graston technique with foot insole.

Experimental

Participants receive Graston technique and foot insole followed by strengthning of intrinsic foot muscles along with standard physical therapy. (Ice pack for 10 minutes, TENS, static stretching of calf muscles and plantar fascia).

干预措施: Graston with foot insole. (Other)

Graston technique without foot insole.

Active Comparator

Participants only receive Graston technique and standard physical therapy. TENS for 10 minutes, Static stretching of plantar fascia and Ice pack for 10 minutes.

干预措施: Graston without insole. (Other)

结局指标

主要结局

Numeric Pain Rating Scale (NPRS)

时间窗: 8 weeks

The Numeric Pain Rating Scale (NPRS) is a simple and widely used tool in healthcare to assess a patient's pain intensity. It allows individuals to self-report their pain on a scale from 0 to 10, where 0 represents "no pain" and 10 represents the "worst possible pain." The scale is divided into categories, with 1-3 indicating mild pain, 4-6 representing moderate pain, and 7-10 corresponding to severe pain (17). This rating system helps healthcare providers understand a patient's pain level, enabling them to monitor changes over time and evaluate the effectiveness of various treatments. By providing a consistent and quantifiable measure of pain, the NPRS plays an important role in managing chronic pain, aiding in the treatment of musculoskeletal conditions. NPRS scores has a test-retest reliability of 0.61 to 0.88

Universal Goniometer

时间窗: 8 weeks

A Goniometer is a tool commonly used in physical therapy and orthopedics to measure joint range of motion (ROM), aiding in the assessment of flexibility and identifying movement limitations. This device typically consists of two arms-a stationary arm and a movable arm-connected at a central axis with a degree scale for accurate readings. Various types of Goniometer serve specific needs, including the universal goniometer for larger joints, a finger goniometer for smaller joints, inclinometers for spinal measurements, and digital versions for precise digital readouts. To use a goniometer, a clinician aligns its axis with the joint, positioning one arm along the fixed part of the body and the other along the moving limb, then records the degree at the endpoint of ROM. Goniometers are essential for monitoring recovery progress, setting rehabilitation goals, and ensuring effective treatment planning (18). Correlation coefficient (ICC) of ankle angle values is (dorsiflexion = 0.96).

Foot and ankle disability index (FADI)

时间窗: 8 weeks

The FADI specific questionnaire for foot and ankle consists in a total of 26 items, grouped into three different categories of questions: 16 items (1-16) related to walking, 6 items (17-22) to daily activity and 4 (23-26) to pain. Each item can be scored on a 5-points Likert scale (from zero to four), with a maximum total score of 104 points; the score can be transformed into percentage if a comparison with other questionnaires is needed. The best possible score (104) corresponds to compete absence of any difficulty in daily activities and no pain; the minimum score of zero (0) corresponds to the worst possible condition i.e. severe limitation in walking and daily activities as well as pain presence.

Modified Foot Health Status Questionnaire(FHSQ)

时间窗: 8 weeks

The FHSQ consists of 13 questions reflecting four foot health-related domains: pain (4questions), function (4 questions), footwear (3 questions), and general foot health (2 questions). Each question (item) is scored on a 5-point Likert scale, and individual item scores are then re-coded, tabulated, and finally transformed to a scale ranging from 0 (indicating poorest foot health) to 100 (indicating best foot health) for each of the 4 domains. The FHSQ demonstrates a high degree of content, criterion, and construct validity and high retest reliability, and has been used as an outcome measure in clinical trials for a range of foot disorders.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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