MedDataX Logo

The Effects of Transcutaneous Electrical Nerve Stimulation in Patients With Total Knee Replacement

NCT ID: NCT05115565

Last Updated: 2021-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-15

Study Completion Date

2022-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Nowadays, it is seen that the results of an increasing number of TDP surgeries increase patient satisfaction and have satisfactory results. However, TDP surgery is a serious trauma that causes pain in patients.

TENS is an easy-to-apply, inexpensive, noninvasive, noninvasive method that uses electrical current to activate nerves with therapeutic effects in the treatment of acute and chronic pain. It is also seen as a promising practice in patients undergoing total knee replacement surgery by the American Society of Regional Anesthesia and Pain Medicine (ASRA) and the European Society of Regional Anaesthesia and Pain Therapy (ESRA).

The study was planned as a randomized controlled study to examine the effect of TENS on acute pain, functionality and quality of life after TDP. The hypotheses of the study; H1a- TENS applied after TDP positively affects the level of pain in patients. H1b- TENS applied after TDP affects the improvement in functional status in patients.

H1c- TENS applied after TDP reduces the analgesia consumption of patients. H1d- TENS applied after TDP positively affects the quality of life of patients. Type of Study: Randomized controlled trial. Method: 52 patients (26 controls, 26 interventions) who underwent total knee replacement surgery will be randomized and divided into two groups as intervention and control groups. TENS will be applied to the intervention group in addition to the routine treatment and care in the clinic, on the other hand, no intervention will be made to the control group other than routine treatment and care. Data will be collected with Patient identification form, Pain Evaluation Form, Visual Analogue Scale (VAS), Analgesic Drug Tracking Form, Joint Range of Motion (ROM) Follow-up Form, Western Ontario and McMaster Universities Arthritis Index (WOMAC), Quality of Life Scale (SF-36).

While evaluating the data, it is planned to be analyzed as randomized.It is planned to use multiple completion methods when there are missing data.Statistical analyzes are planned to be evaluated with the SPSS-24 package program. It is planned to use frequency charts and descriptive statistics in order to interpret the data, parametric techniques for normal distributions and non-parametric techniques for non-normal distributions.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Total Knee Replacement Transcutaneous Electrical Nerve Stimulation Total Knee Replacement Surgery

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Total knee replacement Transcutaneous Electrical Nerve Stimulation Pain Nursing Quality of life

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control group

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Intervention group

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.

Group Type EXPERIMENTAL

TENS (Transcutaneous Electrical Nerve Stimulation) Application

Intervention Type DEVICE

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

TENS (Transcutaneous Electrical Nerve Stimulation) Application

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 Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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,
* Absence of signs of venous thromboembolism,
* Having an ASA score of I and II,
* Agree to participate in the research and
* Know how to read and write

Exclusion Criteria

* 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,
* Having symptoms of venous thrombosis,
* Not having ASA score I or II,
* Not agreeing to participate in the study,
* Illiteracy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Bozok University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Nilgun Ozbas

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Nilgün Özbaş, Assist. Prof

Role: PRINCIPAL_INVESTIGATOR

Bozok University

Emre Ersoy, Assist. Prof

Role: STUDY_CHAIR

Bozok University

Hacı Ali Olçar, Doctor

Role: STUDY_CHAIR

Bozok University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Yozgat Bozok University Research and Application Hospital

Yozgat, Merkez, Turkey (Türkiye)

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nilgün Özbaş, Assist Prof

Role: CONTACT

Phone: +90-354- 314- 14- 15

Email: [email protected]

Murat Korkmaz, Professor

Role: CONTACT

Phone: +90-532-303-47-72

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Nilgün Özbaş, Assist Prof

Role: primary

Murat Korkmaz, Professor

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2017-KAEK-189_2021.09.22_05

Identifier Type: -

Identifier Source: org_study_id