NCT06914323

Brief Summary

Pain is a subjective and unpleasant sensory and emotional experience associated with actual or potential tissue damage. Fractures result from a disruption in the continuity of bone, where bones are subjected to traction, twisting, or compression, causing damage to the surrounding muscular tissues. The treatment of displaced or complex fractures typically requires internal fixation surgery. 89% of fracture patients experience postoperative pain and swelling by the second day following open reduction and internal fixation surgery. These negative sensations can lead to increased pain, limb deformity, and neurovascular compression injuries. If postoperative pain is not adequately managed, it can affect wound healing, increase metabolism and oxygen consumption, and place additional strain on cardiopulmonary function. It is necessary to integrate alternative, non-pharmacological, non-invasive pain relief measures. Effectively and safely alleviating acute postoperative pain can enhance comfort, promote early mobilization, improve adherence to postoperative physical therapy, enhance quality of life and shorten hospital stays.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
140

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Feb 2025

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

February 18, 2025

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
26 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2026

Completed
Last Updated

April 6, 2025

Status Verified

April 1, 2025

Enrollment Period

1 year

First QC Date

March 11, 2025

Last Update Submit

April 3, 2025

Conditions

Outcome Measures

Primary Outcomes (3)

  • Changes in pain

    Pain is measured using the Visual Analog Scale (VAS). The left end is labeled as "no pain," which represents 0, and the right end as "the most severe pain imaginable," which represents 100.

    post op day 1 to post op day 2

  • Change in limb swelling

    Foot circumference at the midpoint of the line connecting the fifth toe to the lateral malleola is measured in centimeters for swelling assessment. A measuring tape is used. During the measurement, the patient is positioned in a supine posture.

    post op day 1 to post op day 2

  • Changes in patient comfort

    Shortened General Comfort Questionnaire (SGCQ) for measuring comfort. The questionnaire consists of 28 items, assessed on a 6-point Likert scale ranging from "strongly disagree" to "strongly agree." A score of 1 represents "strongly disagree," while a score of 6 represents "strongly agree." The total score ranges from 28 to 148, with higher scores indicating greater levels of comfort.

    post op day 1 to post op day 2

Study Arms (1)

Acupressure

EXPERIMENTAL
Procedure: Acupressure

Interventions

AcupressurePROCEDURE

improvements in pain, limb swelling, and comfort

Acupressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • The patient was hospitalized due to injuries from an accident, diagnosed with unilateral femoral fracture and underwent open reduction internal fixation surgery, hemiarthroplasty, and total hip arthroplasty.
  • Adults aged 18 years or older.
  • Conscious and able to communicate in Mandarin or Taiwanese (Min Nan).
  • Intact and without missing lower limbs.
  • Willing to sign the informed consent form after being briefed on the study objectives and procedures.

You may not qualify if:

  • Diagnosis of musculoskeletal tumors.
  • History of cerebrovascular accident or peripheral vascular neuropathy.
  • Major medical conditions such as cirrhosis, renal failure, heart failure, cancer, and severe brain diseases.
  • Edema caused by nutritional deficiency or mucinous causes.
  • Pregnant or lactating women.
  • Patients using patient-controlled analgesia post-surgery.
  • Severe psychiatric disorders or perceptual disorders.
  • Platelet count less than 20 x 10\^3/uL before screening.
  • Albumin less than 3.5g/dL before screening.
  • Individuals closely related to the trial personnel, such as immediate family or dependents of the principal investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hungkuang University

Taichung, Taiwan

Location

MeSH Terms

Interventions

Acupressure

Intervention Hierarchy (Ancestors)

Therapy, Soft TissueMusculoskeletal ManipulationsComplementary TherapiesTherapeuticsPhysical Therapy ModalitiesRehabilitation

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Nurse practitioner

Study Record Dates

First Submitted

March 11, 2025

First Posted

April 6, 2025

Study Start

February 18, 2025

Primary Completion

February 18, 2026

Study Completion

February 18, 2026

Last Updated

April 6, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations