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

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.

Study Overview

• Status: Completed
• Conditions: Meniscus Tear
• Intervention / Treatment: Other: Enhanced Care with PMRT and Acupressure; Other: standard care

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 65
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Gansu
    • Lanzhou, Gansu, China, 730000
      • Chengguanqu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental group; 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.	Other: Enhanced Care with PMRT and Acupressure; Progressive Muscle Relaxation Training (PMRT) is a structured strategy created to reduce psychological and physiological stress by alternating muscle contraction and relaxation.Rooted in traditional Chinese medicine's meridian theory, acupressure employs manipulative techniques on distinct acupoints to induce therapeutic effects 18. Targeting enhanced circulation, pain relief, muscle relaxation, and systemic regulation, acupressure's efficacy as both a preventive and therapeutic modality in complementary and alternative medicine is well-established
Experimental: Control group; 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.	Other: standard care; vital sign monitoring, positional support, dietary management, pain control, psychological support, functional training, and educational initiatives on health matters.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TSK	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).	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).
VAS	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.	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).
KSS	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.	This scoring was performed on the day of patient discharge(up to 14 days).

Collaborators and Investigators

• Sponsor: Gansu University of Chinese Medicine
• Investigators: Principal Investigator: rui xu, Gansu University of Chinese Medicine

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2021
• Primary Completion (Actual): November 1, 2022
• Study Completion (Actual): June 30, 2023

Study Registration Dates

• First Submitted: May 2, 2024
• First Submitted That Met QC Criteria: May 8, 2024
• First Posted (Actual): May 10, 2024

Study Record Updates

• Last Update Posted (Actual): May 10, 2024
• Last Update Submitted That Met QC Criteria: May 8, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders; Phobic Disorders; Kinesiophobia
• Other Study ID Numbers: Interventional (Oncolys BioPharma Inc)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No