Investigating how edema affects TENS amplitude settings after knee surgery
Does Edema After Knee Arthroplasty Affect the Adjustment of TENS Amplitude
This study is testing how swelling affects the settings of a pain relief device called TENS in people who have just had knee surgery.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 125 (estimated) |
| Ages | 40 Years and up |
| Sex | All |
| Sponsor | Karamanoğlu Mehmetbey University Academic / other |
| Locations | 1 site (Karaman) |
| Trial ID | NCT06153277 on ClinicalTrials.gov |
What this trial studies
This observational study aims to compare the amplitude settings of three different frequency modes of Transcutaneous Electrical Nerve Stimulation (TENS) in patients who have undergone total knee arthroplasty. It evaluates the impact of edema on electrical resistance and how it may influence TENS amplitude adjustments. Participants will be assessed before and after surgery, with comparisons made between the preoperative state and the contralateral knee. The study seeks to enhance postoperative pain management by understanding the effects of edema on TENS application.
Who should consider this trial
Good fit: Ideal candidates are individuals aged 40 and older undergoing unilateral total knee arthroplasty.
Not a fit: Patients with significant sensory impairments, excessive knee joint effusion, or contraindications for TENS will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve pain management strategies for patients recovering from knee surgery.
How similar studies have performed: While TENS is widely used for pain management, this specific investigation into the effects of edema on TENS amplitude settings is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Karaman
- Karaman Training and Research Hospital — Karaman, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Aynur Basaran, MD,Prof — Karaman Training and Research Hospital
- Study coordinator: Aynur Basaran, MD, Prof
- Email: aynurbasaran@gmail.com
- Phone: +90 338 226 3225
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.