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临床试验/NCT06023823
NCT06023823已完成不适用

Dry Needling of the Abductor Hallucis Muscle in the Management of Hallux Valgus; Effect on Pain, Function and Valgus Angle

Istanbul Training and Research Hospital1 个研究点 分布在 1 个国家目标入组 31 人开始时间: 2023年5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
已完成
发起方
入组人数
31
试验地点
1
主要终点
Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?

研究概览

简要总结

Forty Hallux valgus patients between the ages of 25-65 years, who are admitted to the Physical Medicine and Rehabilitation clinic with the complaint of 1st Metatarsophalangeal (MTF) pain and who meet the inclusion and exclusion criteria will be included. Hallux valgus (HV) angles will be measured by dorsoplantar radiography before the patients start the study. The HV angle was measured as the angle between the bisection line of the first metatarsal bone and the first proximal phalanx. Demographic data (age, gender, body mass index) will be recorded at the beginning of the study. Then, the initial Foot Functional Index (FFI) and Visual Analog Scale (VAS) scales were completed. The 1st MTF joint angle was also measured with a goniometer and recorded before starting the study. The patients were divided into two groups. The first group will be given 3 sessions of dry needling with Seirin branded 0.6*50 mm acupuncture needles for trigger point in the abductor hallucis muscle and toe-spread-out exercise. The second group will receive only toe-spread-out exercises. After starting the treatment, FFI and VAS scores and 1st MTF angles will be measured and recorded weekly with a goniometer. At the end of the 3-week treatment, the FFI and VAS scores of the participants will be re-evaluated after 1 week and 1 month, and the participants will be re-evaluated with a goniometer. The hallux valgus angle will be re-evaluated with X-ray 4 weeks after the end of the treatment.

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
Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •25-65 years old with pain for more than 4 weeks
  • •Hallux valgus angle between 16-40 degrees
  • •Activity VAS value above 4

排除标准

  • •Patients diagnosed with rheumatologic diseases
  • •Those diagnosed with Diabetes Mellitus (DM), those with chronic liver and kidney failure
  • •Those who received anti-inflammatory-analgesic treatment in the last 1 week
  • •Diagnosed with inflammatory rheumatic disease
  • •Those with a history of foot surgery
  • •Those with mid or hindfoot deformity
  • •Those with 1st MTF joint problems other than hallux valgus
  • •Those with a history of orthotic use
  • •Previous history of central or peripheral nerve damage, lower extremity neuropathy
  • •Those diagnosed with Diabetes Mellitus
  • •Those with cognitive impairment
  • •Unassisted mobilization

研究组 & 干预措施

Toe spread out treatment

Active Comparator

干预措施: Toe spread out (Other)

Toe spread out treatment

Active Comparator

干预措施: Dry needling+Toe spread out (Other)

Dry needling

Active Comparator

干预措施: Dry needling+Toe spread out (Other)

结局指标

主要结局

Does dry needling make an additional contribution to the spread out exercise in the functional management of hallux valgus?

时间窗: Baseline, 3 week, 7 week

Function assessment was performed with (Foot Functional INdex) FFI score at baseline, 3.w and 8.w.

Does dry needling provide an additional contribution to the spread out exercise in the hallux valgus angle?

时间窗: Baseline, 7 week

The hallux valgus angle will be measured at baseline and 7.w on direct radiographs.

Does dry needling make an additional contribution to the spread out exercise in the pain management of hallux valgus?

时间窗: Baseline, 3 week, 7 week

Pain assessment was performed with (Visual Analog Scale) VAS score at baseline, 3.w and 8.w.

次要结局

未报告次要终点

研究者

发起方
Istanbul Training and Research Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Burak Tayyip Dede

Medical Doctor

Istanbul Training and Research Hospital

研究点 (1)

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