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

Meniscus Tear Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06409715
• Other study ID #: interventional
• Status: Completed
• Phase: N/A
• Start date: November 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: May 2024
• Source: Gansu University of Chinese Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: June 30, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Kinesiophobia
• Meniscus Tear

Intervention

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

Locations

Country	Name	City	State
China	Chengguanqu	Lanzhou	Gansu

Sponsors (1)

Lead Sponsor	Collaborator
Gansu University of Chinese Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).
Primary	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).
Primary	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).