Does Edema Affect the Adjustment of TENS Amplitude

NCT06153277 | Recruiting

• 1 other identifier: 09-2023/01
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this pre-post clinical trial is to compare the amplitude settings of three different frequency TENS modes (Conventional TENS, LF TENS, HF TENS) in patients who had undergone total knee arthroplasty, both with the preoperative state and with the contralateral knee. The main question it aims to answer is: Can the electrical resistance of edematous tissue be affected and change the TENS amplitude setting? Participants will be evaluated before and after surgery. For each TENS modulation the amplitude at which tingling is felt, the current is clearly felt, and is maximum tolerated and/or muscle contraction occurred, will be documented. TENS amplitudes for all three TENS modes will be compared, both with the preoperative state and with the contralateral knee.

Conditions

Edema Leg; Pain

Keywords

Transcutaneous electrical nerve stimulation; Amplitude adjustment; Arthroplasty

Outcome Measures

Primary Outcomes (3)

• The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements

  Univariate statistical analyses will be performed to calculate differences in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements on both knees and between knees

  2-3 days

• The difference in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements

  Univariate statistical analyses will be performed to calculate differences in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements on both knees and between knees

  2-3 days

• The difference in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements

  Univariate statistical analyses will be performed to calculate differences in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements on both knees and between knees

  2-3 days

Secondary Outcomes (2)

• The effect of the amount of edema on the amplitudes of TENS modes

  2-3 days

• The effect of the type of anesthesia applied on the amplitudes of TENS modes

  203 days

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who applied to Karaman Training and Research Hospital Orthopedics and Traumatology Polyclinic and were planned for unilateral knee arthroplasty

You may qualify if:

• Age ≥ 40 years
• Patients undergoing unilateral total knee arthroplasty

You may not qualify if:

• Patients with scars in any of both knee areas
• Patients who have previously had surgery on the control leg
• Patients undergoing surgery due to trauma or cancer
• Patients with sensory impairments
• Patients with excessive effusion and edema in the knee joints before the surgery (eg. Inflammatory arthropathy, gonarthrosis exacerbation, etc.)
• Mental impairment, or poor general health status that would interfere with assessments during TENS application.
• Any contraindication for TENS (allergy to the TENS electrodes, skin conditions or skin sensation impairment in the areas where the electrodes will be placed, pacemaker or other implanted electrical device, epilepsy, pregnancy)

Sponsors & Collaborators

• Karamanoğlu Mehmetbey University: lead
• Karaman Training and Research Hospital: collaborator

Study Sites (1)

Karaman Training and Research Hospital

Karaman, 70200, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Aynur Basaran, MD,Prof

  Karaman Training and Research Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Aynur Basaran, MD, Prof

CONTACT

+90 338 226 3225; aynurbasaran@gmail.com

Yurdagul Bahran Mustu, MD

CONTACT

yurdagulbahran@gmail.com

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Proffessor Dr, MD

Study Record Dates

• First Submitted: November 22, 2023
• First Posted: December 1, 2023
• Study Start: December 7, 2023
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: December 11, 2025

Record last verified: 2025-12

Locations

TU (1)