NCT06409715

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
65

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

May 2, 2024

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 10, 2024

Completed
Last Updated

May 10, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

May 2, 2024

Last Update Submit

May 8, 2024

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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).

Study Arms (2)

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.

Other: Enhanced Care with PMRT and Acupressure

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.

Other: standard care

Interventions

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 group

vital sign monitoring, positional support, dietary management, pain control, psychological support, functional training, and educational initiatives on health matters.

Control group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chengguanqu

Lanzhou, Gansu, 730000, China

Location

Related Publications (1)

  • Xu R, Miao J, Gong Y, Jia H, Wu H, Wang W, Wang H, Dong M, Zhang Y. A Randomized, Double-Blind, Parallel-Controlled Trial: Addressing Kinesiophobia in Post-Meniscoplasty Patients Through Progressive Muscle Relaxation Training and Acupressure. Pain Res Manag. 2025 Mar 31;2025:1270985. doi: 10.1155/prm/1270985. eCollection 2025.

MeSH Terms

Interventions

AcupressureStandard of Care

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitationQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • rui xu

    Gansu University of Chinese Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 2, 2024

First Posted

May 10, 2024

Study Start

November 1, 2021

Primary Completion

November 1, 2022

Study Completion

June 30, 2023

Last Updated

May 10, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations