Addressing Kinesiophobia in Post-Meniscoplasty Patients Through Progressive Muscle Relaxation Training and Acupressure
1 other identifier
interventional
65
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Nov 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2023
CompletedFirst Submitted
Initial submission to the registry
May 2, 2024
CompletedFirst Posted
Study publicly available on registry
May 10, 2024
CompletedMay 10, 2024
May 1, 2024
1 year
May 2, 2024
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
EXPERIMENTALProgressive 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.
Control group
EXPERIMENTALFollowing 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.
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
vital sign monitoring, positional support, dietary management, pain control, psychological support, functional training, and educational initiatives on health matters.
Eligibility Criteria
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
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.
PMID: 40201731DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
rui xu
Gansu University of Chinese Medicine
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