ClinicalTrials.gg
CompletedNCT06409715Updated May 10, 2024

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

An interventional study of Enhanced Care with PMRT and Acupressure and standard care in Meniscus Tear, sponsored by Gansu University of Chinese Medicine. Completed at 1 site in China. Per ClinicalTrials.gov, last updated 2024-05-10.

Sponsored by Gansu University of Chinese Medicine · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Nov 2021, registered May 2024).
Phase
Not applicable
Study type
Interventional
Enrollment
65
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Meniscus Tear
03

In context

Lead sponsor

Gansu University of Chinese Medicine is the lead sponsor of 3 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • 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

  • 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

Interventions

  • OtherEnhanced 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

  • Otherstandard care

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

06

What researchers measure

Primary outcomes

  1. 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).

    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).

  2. 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.

    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).

  3. 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.

    Time frame: This scoring was performed on the day of patient discharge(up to 14 days).

07

Study locations

1 site
  • Chengguanqu
    Lanzhou, Gansu 730000, China
08

References and documents

Publications

  • 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. PubMed 40201731 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2021 to primary completion in Nov 2022, 12 months.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2024
First posted
May 10, 2024
StartActual
Nov 1, 2021
Primary completionActual
Nov 1, 2022
CompletionActual
Jun 30, 2023
Last update
May 10, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 10, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06409715
Lead sponsor
Gansu University of Chinese Medicine
Responsible party
Junfang Miao (Principal Investigator, Gansu University of Chinese Medicine) — Principal investigator
First posted
May 10, 2024
Start date
Nov 1, 2021
Primary completion
Nov 1, 2022
Completion
Jun 30, 2023
Last update
May 10, 2024

Study contacts

rui xu
principal investigator · Gansu University of Chinese Medicine

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.

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