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临床试验/NCT06409715
NCT06409715已完成不适用

Addressing Kinesiophobia in Post-Meniscoplasty Patients Through Progressive Muscle Relaxation Training and Acupressure

Gansu University of Chinese Medicine1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2021年11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
65
试验地点
1
主要终点
VAS

研究概览

简要总结

The objective of this clinical trial is to determine whether progressive muscle relaxation training and acupressure can reduce kinesiophobia (fear of movement) in patients recovering from meniscoplasty surgery. The study will also monitor the safety of these non-pharmacological interventions. The main questions the trial aims to answer are:

Does the combination of progressive muscle relaxation training and acupressure decrease kinesiophobia in post-meniscoplasty patients? What are the other benefits, if any, of these interventions in terms of pain management and functional mobility? Are there any negative effects associated with these treatments?

Participants in the study will:

Receive progressive muscle relaxation training and acupressure or a placebo control treatment for a duration of 3 months.

Visit the clinic once every month for evaluation and follow-up treatments. Keep a journal recording their fear of movement levels, pain levels, and mobility status.

详细描述

This study received approval from the Ethics Committee of a tertiary class A hospital in Lanzhou, ID 202159. The research period extended from December 2021 to February 2023. Subjects comprised patients who developed kinesiophobia following meniscus shaping surgery within the Sports Medicine Department of the aforementioned hospital in Lanzhou.

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

性别
All
接受健康志愿者
否

入选标准

  • •Patients confirmed with meniscal damage as per established diagnostic guidelines and subjected to meniscus sculpting surgery
  • •Individuals post-meniscus surgery exhibiting a Tampa Scale of Kinesiophobia (TSK) score exceeding 37 points
  • •First-time patients receiving unilateral meniscal surgery
  • •Exclusive employment of the meniscus sculpting surgical procedure
  • •Participation were entirely voluntary for all research participants

排除标准

  • •Patients with compromised consciousness or communicative impairments
  • •Individuals with a history or presence of post-surgical lower limb thrombosis, resulting in activity limitation
  • •Patients enduring deformities in the hip or ankle joints
  • •Those previously engaged in analogous research endeavors

研究组 & 干预措施

Experimental group

Experimental

Progressive Muscle Relaxation Training (PMRT) involves a series of 11 steps, each involving muscle tension for 10 seconds, followed by 5 seconds of relaxation, with each step repeated twice. This method, provided by the Chinese Medical Association Audiovisual Publishing House, starts on the third postoperative day if there are no complications, with two 30-minute sessions daily. After PMRT, patients proceed with an Acupressure protocol. The session begins with 5-10 minutes of kneading around the knee and pinching the quadriceps, followed by lighter kneading around the patella and its periphery. Knee movements are made within pain limits. Acupressure targets points Zusanli(S36), Sanyinjiao (SP6), and Yanglingquan(GB34) with pressure held for 10 seconds when soreness or numbness is felt. Each point is treated in 3-5 cycles during the twice-daily, 5-minute sessions, concluding with palm percussion on the calf to relax muscles.

干预措施: Enhanced Care with PMRT and Acupressure (Other)

Control group

Experimental

Following recommended protocols from "Arthroscopic Surgery and Sports Rehabilitation Nursing" 26, post-meniscectomy patient care primarily involves vital sign monitoring, positional support, dietary management, pain control, psychological support, functional training, and educational initiatives on health matters.

干预措施: standard care (Other)

结局指标

主要结局

VAS

时间窗: Data from VAS were gathered within two days post-operation, on the first day after intervention (i.e., the third postoperative day), the fifth day (i.e., the seventh postoperative day), and on the day of discharge(up to 14 days).

Visual Analogue Scale(VAS) Pain levels were quantified using VAS, which rates pain intensity on a 100 mm line ranging from 0 (no pain) to 10 (severe pain). The VAS is widely deemed a credible and efficacious pain rating tool 31.

TSK

时间窗: Data from TSK were gathered within two days post-operation, on the first day after intervention (i.e., the third postoperative day), the fifth day (i.e., the seventh postoperative day), and on the day of discharge(up to 14 days).

The Tampa Scale for Kinesiophobia (TSK) The TSK assesses fear of movement/(re)injury and ranges from 17 to 68, indicating the degree of fear; higher scores denote increased apprehension. It has a Cronbach's alpha of 0.70-0.92 and a test-retest reliability above 0.80 28, 29. The Chinese version of TSK was cross-culturally adapted and validated by Wei et al.displaying good reliability (Cronbach's alpha: 0.74) and validity (test-retest reliability: 0.86).

KSS

时间窗: This scoring was performed on the day of patient discharge(up to 14 days).

American knee society score(KSS ) The KSS scores knee functionality in two domains: self-reported symptoms, signs, and a functional component reflecting walking and stair climbing abilities. Higher scores represent more optimal knee function and mobility capacities. Each KSS domain is rated from 0 to 100 and can be considered individually or collectively.

次要结局

未报告次要终点

研究者

发起方
Gansu University of Chinese Medicine
申办方类型
Other
责任方
Principal Investigator
主要研究者

Junfang Miao

Principal Investigator

Gansu University of Chinese Medicine

研究点 (1)

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