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临床试验/NCT07078539
NCT07078539尚未招募不适用

Comparative Effect of Kaltenborn and Mulligan Mobilization With Intrinsic Foot Muscle Strengthening on Pain, Functional Status, and Windlass Mechanism in Patients With Plantar Fasciitis

Riphah International University2 个研究点 分布在 1 个国家目标入组 74 人开始时间: 2025年7月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
74
试验地点
2
主要终点
Numeric Pain Rating Scale

研究概览

简要总结

This study will compare the effects of Kaltenborn and Mulligan ankle mobilization techniques, combined with intrinsic foot muscle strengthening, on pain, functional status, and dorsiflexion range of motion in patients with plantar fasciitis. Eighty-two participants with chronic heel pain will be randomly allocated into two groups. Both groups will receive standard care including ultrasound therapy, stretching, and cryotherapy, while Group A will receive Kaltenborn mobilization and Group B will receive Mulligan mobilization. Pain, function, and ankle range of motion will be assessed at baseline and after three weeks of treatment.

详细描述

This prospective randomized clinical trial will aim to evaluate and compare the effectiveness of two manual therapy techniques-Kaltenborn and Mulligan mobilizations-combined with intrinsic foot muscle strengthening in the treatment of plantar fasciitis. The study will be conducted at two physiotherapy clinics in Sialkot, Pakistan. A total of 82 eligible participants aged 30-60 years, diagnosed with plantar fasciitis, will be enrolled using non-probability convenience sampling and then randomised into two equal groups through the lottery method.

Group A will receive Kaltenborn mobilization techniques applied to the talocrural and subtalar joints, in addition to conventional treatment (therapeutic ultrasound, plantar fascia and calf stretching, intrinsic foot muscle strengthening, and cryotherapy). Group B will receive Mulligan mobilization with movement (MWM) applied to the same joints, alongside the same conventional treatment.

Interventions will be delivered twice weekly for three weeks (total six sessions). The primary outcomes will include changes in pain intensity (Numeric Pain Rating Scale), functional disability (Foot Function Index), and ankle dorsiflexion range of motion (measured using a goniometer). Measurements will be taken at baseline and at the end of the third week. It is hypothesised that Kaltenborn mobilization may demonstrate superior outcomes in pain reduction and functional improvement compared to Mulligan MWM when combined with strengthening exercises.

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)

入排标准

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

入选标准

  • •Age group between 30-
  • •Both genders (male and female) included.
  • •Subjects with the ankle and heel pain complain especially morning or after rest and limited ankle ROM due to pain
  • •Positive Windlass test: Pain increase upon toe standing and decreases upon walking.
  • •Duration of pain in 4 weeks or more.
  • •Tenderness on medial calcaneal tuberosity.
  • •NPRS score of 4 or more

排除标准

  • •Patients contraindicated to manual therapy (tumor, fracture or osteoporosis). Any history of knee, tibia, fibula, ankle or foot surgery or stress fracture of calcaneum.
  • •Previously received physiotherapy treat.
  • •History of non-steroidal anti-inflammatory medications or corticosteroid injection in last 3 weeks prior to surgery.
  • •Pregnancy (because of sudden weight changes and pedal edema which causes heel pain).
  • •Conditions like rheumatoid arthritis, ankylosing spondylitis, systematic lupus erythematous, peripheral neuropathy, sever's disease, severe vascular disease or tarsal tunnel.

研究组 & 干预措施

Kaltenborn Mobilization Group

Experimental

Participants in this group will receive Kaltenborn mobilization techniques applied to the talocrural and subtalar joints. Mobilizations will be performed as Grade III passive accessory glides for 10 repetitions per joint, each sustained for 15 seconds with a 10-second rest interval

干预措施: Kaltenborn Mobilization Group (Other)

Mulligan Mobilization Group

Experimental

Participants in this group will receive Mulligan mobilization with movement (MWM) techniques applied to the talocrural and subtalar joints. Mobilizations will be applied as 3 sets of 10 repetitions per joint with 1-minute rest between sets.

干预措施: Mulligan Mobilization Group (Other)

结局指标

主要结局

Numeric Pain Rating Scale

时间窗: Baseline and at the end of Week 3 (post-intervention)

Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Foot Function Index - FFI

时间窗: Baseline and at the end of Week 3 (post-intervention)

Functional disability will be evaluated using the Foot Function Index (FFI), a validated questionnaire assessing foot pain, disability, and activity limitation. It comprises 23 items scored on a visual analogue scale, with higher scores indicating greater impairment.

Ankle Dorsiflexion Range of Motion

时间窗: Baseline and at the end of Week 3 (post-intervention)

Ankle dorsiflexion will be measured using a universal goniometer to assess changes in passive range of motion.

Windlass Test

时间窗: Baseline and at the end of Week 3 (post-intervention)

The Windlass Test will be used as a clinical indicator of plantar fascia integrity and responsiveness. The test will be performed in a weight-bearing position by passively dorsiflexing the great toe while the patient stands on the affected foot. A positive result is defined by reproduction of heel or arch pain during the manoeuvre.

Numeric Pain Rating Scale

时间窗: Baseline and at the end of Week 3 (post-intervention)

Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), a validated 11-point scale ranging from 0 (no pain) to 10 (worst imaginable pain).

Foot Function Index - FFI

时间窗: Baseline and at the end of Week 3 (post-intervention)

Functional disability will be evaluated using the Foot Function Index (FFI), a validated questionnaire assessing foot pain, disability, and activity limitation. It comprises 23 items scored on a visual analogue scale, with higher scores indicating greater impairment.

Ankle Dorsiflexion Range of Motion

时间窗: Baseline and at the end of Week 3 (post-intervention)

Ankle dorsiflexion will be measured using a universal goniometer to assess changes in passive range of motion.

Windlass Test

时间窗: Baseline and at the end of Week 3 (post-intervention)

The Windlass Test will be used as a clinical indicator of plantar fascia integrity and responsiveness. The test will be performed in a weight-bearing position by passively dorsiflexing the great toe while the patient stands on the affected foot. A positive result is defined by reproduction of heel or arch pain during the manoeuvre.

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 (2)

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