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NCT Number: NCT06409715

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.

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Key information

Conditions

Meniscus Tear

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Chengguanqu

Lanzhou, Gansu, 730000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Enhanced Care with PMRT and Acupressure

Other

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

Standard care

Other

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

Primary outcomes

  1. TSK

    Time frame: 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).

  2. VAS

    Time frame: 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.

  3. KSS

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gansu University of Chinese Medicine

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2023
First posted
May 10, 2024
Registry last updated
May 10, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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