NCT05115565

Brief Summary

Total Knee Replacement (TDP) is considered the best treatment option available when conservative methods such as anti-inflammatory or physical therapy fail. However, TDP surgeries are also a serious trauma that causes severe pain in patients. Uncontrollable pain exacerbates the stress response and causes morbidity and mortality by causing negative changes in the neuroendocrine, respiratory, cardiovascular, gastrointestinal, renal and immune systems. Therefore, the relief of pain has very important effects on the patient's recovery process, functional status and quality of life. Transcutaneous Electrical Nerve Stimulation (TENS) is one of the non-pharmacological methods for pain relief in TDP surgeries. This study was planned as a randomized controlled trial to examine the effects of TENS after TDP on acute pain, functionality and quality of life.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2021

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

September 5, 2021

Completed
2 months until next milestone

First Posted

Study publicly available on registry

November 10, 2021

Completed
5 days until next milestone

Study Start

First participant enrolled

November 15, 2021

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2022

Completed
Last Updated

November 10, 2021

Status Verified

October 1, 2021

Enrollment Period

10 months

First QC Date

September 5, 2021

Last Update Submit

October 30, 2021

Conditions

Total Knee ReplacementTranscutaneous Electrical Nerve StimulationTotal Knee Replacement Surgery

Keywords

Total knee replacementTranscutaneous Electrical Nerve StimulationPainNursingQuality of life

Outcome Measures

Primary Outcomes (1)

  • Visual Analogue Scale (VAS) Change

    The Visual Analogue Scale (VAS) is a scale where the pain is evaluated between 0-10 (0; no pain, 10; unbearable pain) on a ruler that can be used horizontally or vertically, on which the patient can mark his or her own pain.The length of the distance from the point where there is no pain to the point marked by the patient is measured in centimeters and the numerical value found shows the severity of the patient's pain. It is used in various populations, including patients with total knee replacement, to evaluate both the severity of pain and the effectiveness of treatment/intervention on pain.

    1st day of admission to the clinic change VAS score at before intervention, 24th postoperative hour change from baseline VAS score before the intervention, postoperative 48th, 72th and 96th hours,15th day change from baseline VAS score after intervention

Secondary Outcomes (2)

  • Western Ontario and McMaster Universities Arthritis Index (WOMAC) Change

    1st day of admission to the clinic change WOMAC score at before intervention, change from baseline the WOMAC score at 4th postoperative day, 15th postoperative day change from baseline WOMAC score

  • The Quality of Life Scale (SF-36) Change

    1st day of admission to the clinic change quality of life score at before intervention, 15th postoperative day change from baseline quality of life score

Study Arms (2)

Control group

NO INTERVENTION

When the patients are admitted to the clinic, the patient identification form and the SF-36 Quality of Life Scale will be filled by face-to-face interview method. On the morning of the operation, before the operation, the GCS, EHA and WOMAC index will be filled. After the operation, the pain during rest and movement (24., 48., 72., 96. hours and 15. days) will be evaluated with VAS. The total amount of analgesics used by the patients will be recorded by looking at the nurse observation form records where the nurses recorded the drugs they administered at the 24th, 48th, 72nd, and 96th hours after the surgery, and by asking the patients on the 15th day after discharge. The WOMAC Index will be re-administered at discharge and on the 15th day, and the VCS, ROM, and the SF-36 Quality of Life Scale on the 15th day.

Intervention group

EXPERIMENTAL

Unlike the control group, the patients in the intervention group will be informed about TENS and the application will be made. The electrodes of TENS will be placed 2 cm below and 2 cm above the incision site. TENS settings Frequency: 100 Hz; Pulse width (duration): 150 μs; Flow Intensity (Amplitude): By adjusting it to be 30 mA, TENS will be applied 3 times a day (09.00, 13.00, 17.00) for 20 minutes during the time the patients stay in the clinic (3 days).It is planned to start the TENS application the day after the surgery.

Device: TENS (Transcutaneous Electrical Nerve Stimulation) Application

Interventions

TENS (Transcutaneous Electrical Nerve Stimulation) ApplicationDEVICE

Conventional (traditional) TENS will be applied to the patients. The frequency will be 100 Hz, the pulse width (time) will be 150 μs, the current intensity (amplitude) will be 30 mA. In addition to routine care and treatment, TENS will be applied to intervention group patients.

Intervention group

Eligibility Criteria

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

You may qualify if:

  • Not have had knee replacement surgery before,
  • Having unilateral prosthesis surgery,
  • Not having a pacemaker or arrhythmia,
  • Not having neurological deficit,
  • Absence of sensory loss, paresthesia or hyporeflexia,
  • Not having local or systemic infection,
  • Not using opioids or TENS before surgery,
  • Not having history of chronic pain,
  • Not having history of alcohol or drug use,
  • Not having a psychiatric history,
  • Not having been done to apply epidural analgesia in the postoperative period,
  • Not having serious complications after surgery,
  • Not having a history of neurological disease (SVO, epilepsy, dementia, etc.),
  • Not having active tumor or cancer,
  • Not having fractures or dislocations,
  • +4 more criteria

You may not qualify if:

  • Undergoing previous knee replacement surgery,
  • Having double-sided prosthesis surgery,
  • Having a pacemaker and arrhythmia,
  • Having a neurological deficit,
  • Having loss of sensation, paresthesia or hyporeflexia,
  • Having local or systemic infection,
  • Having been used opioids and or TENS before surgery,
  • Having a history of chronic pain,
  • Having a history of alcohol or drug use,
  • Having a psychiatric history,
  • Administering epidural analgesia in the postoperative period,
  • Developing serious complications after surgery,
  • Having a history of neurological disease (SVO, epilepsy, dementia, etc.),
  • Having an active tumor or cancer,
  • Having fracture or dislocation,
  • +4 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yozgat Bozok University Research and Application Hospital

Yozgat, Merkez, 66100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation TherapyTherapeuticsPhysical Therapy ModalitiesRehabilitationAnalgesiaAnesthesia and Analgesia

Study Officials

  • Nilgün Özbaş, Assist. Prof

    Bozok University

    PRINCIPAL INVESTIGATOR

  • Emre Ersoy, Assist. Prof

    Bozok University

    STUDY CHAIR

  • Hacı Ali Olçar, Doctor

    Bozok University

    STUDY CHAIR

Central Study Contacts

Nilgün Özbaş, Assist Prof

CONTACT

+90-354- 314- 14- 15nilgun.ozbas06@gmail.com

Murat Korkmaz, Professor

CONTACT

+90-532-303-47-72doktormuratkorkmaz@hotmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Due to the nature of the study, patients will not be left blind. The assignment to the groups will be carried out by an independent researcher, and the group will be notified via telephone after the practitioner researcher has approved, evaluated the criteria and performed the pre-tests. At the same time, groups will be named A and B and researchers will be blinded during statistical analysis and reporting.The questionnaires to be applied to the patients included in the study will be administered by an independent researcher.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

September 5, 2021

First Posted

November 10, 2021

Study Start

November 15, 2021

Primary Completion

August 30, 2022

Study Completion

November 30, 2022

Last Updated

November 10, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)