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Recruiting NCT06153277

Does Edema Affect the Adjustment of TENS Amplitude

— Observational Edema Leg Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Edema Leg, Pain. Basic parameters: from 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude

Overview

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.

Detailed description

Transcutaneous Electrical Nerve Stimulation (TENS) is used for the treatment of various acute and chronic pain conditions. It has been shown to increase participation by providing pain control in the rehabilitation of patients undergoing surgery. Evidence is accumulating that it improves patient comfort and reduces the use of analgesic medication in the early postoperative period, so TENS is included in postoperative pain management guidelines.

On the other hand, peripheral blocks have become the preferred method of anesthesia in order to avoid the complications of general anesthesia. When adjusting TENS amplitude for postoperative pain control in these patients, either low amplitudes are preferred or for the amplitude adjustment as a reference, the contralateral side without block is used.

Cautious application is recommended in patients with sensory impairment, impaired cognitive functions, and pediatric patients. In such cases, it is preferable to use TENS at low amplitudes to avoid complications in daily practice. However, using the contralateral extremity as a reference may cause undesirable results as the electrical resistance of the edematous tissue may change.

In this study, it was aimed 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 in the preoperative state and with the contralateral knee.

Primary outcome measures

  • The difference in amplitudes of the conventional TENS mode between pre- and post-arthroplasty measurements [Time frame: 2-3 days]
  • The difference in amplitudes of the high frequency TENS mode between pre- and post-arthroplasty measurements [Time frame: 2-3 days]
  • The difference in amplitudes of the low frequency TENS mode between pre- and post-arthroplasty measurements [Time frame: 2-3 days]
Secondary outcome measures (2)
  • The effect of the amount of edema on the amplitudes of TENS modes [Time frame: 2-3 days]
  • The effect of the type of anesthesia applied on the amplitudes of TENS modes [Time frame: 203 days]

Eligibility criteria

Inclusion criteria

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

Exclusion criteria

  • 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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-crossover

Study locations

Turkey (Türkiye) · 1 center
  • Karaman Training and Research Hospital — Karaman

Identifiers

NCT: NCT06153277 · 09-2023/01

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗