How TENS Affects Pain, Medication Use, and Muscle Function in Older Adults With Hip Fractures (TENS-HIP)
Effects of Transcutaneous Electrical Nerve Stimulation (TENS) on Pain and Analgesic Use and the Association of Clinical and Psychosocial Factors With Muscle Function in Older Adults With Hip Fracture
The goal of this clinical trial is to learn if transcutaneous electrical nerve stimulation (TENS) can reduce perioperative pain in older adults with hip fractures. It will also evaluate its effects on physiological and psychological outcomes. The main questions it aims to answer are:
Does adding TENS to usual care during the preoperative phase reduce pain intensity and analgesic consumption? Does TENS affect pressure pain threshold and vital signs (blood pressure, heart rate, and respiratory rate)?
Researchers will compare active TENS to sham TENS (no perceptible stimulation) to see if TENS is effective in reducing pain and improving related outcomes.
Participants will:
- Undergo a standardized baseline assessment, including evaluation of pain, vital signs, anxiety, discomfort, and pressure pain threshold
- Complete questionnaires assessing quality of life, physical activity, depressive symptoms, anxiety, fear of falling, and pain catastrophizing
- Be randomly assigned to receive either active TENS or sham TENS
- Receive a single 45-minute TENS session
- Have their analgesic use recorded for the 24 hours before and after the intervention.
Przegląd badań
Status
Warunki
Szczegółowy opis
Hip fractures in older adults are commonly associated with significant perioperative pain, which is often managed with opioid analgesics despite their potential adverse effects. Non-pharmacological and non-invasive strategies, such as transcutaneous electrical nerve stimulation (TENS), have been proposed as adjunctive approaches for pain management. While previous studies have primarily focused on postoperative applications, the effects of TENS during the preoperative phase remain unclear.
This randomized clinical trial will include 32 older adults diagnosed with hip fracture. After providing written informed consent, participants will undergo a standardized baseline assessment. Demographic and clinical data, including age, sex, marital status, and education level, will be collected through an anamnesis form.
Physiological and clinical outcomes will be assessed before and after the intervention. These include vital signs (blood pressure, heart rate, and respiratory rate), pain intensity, discomfort level, anxiety level, and pressure pain threshold. Additionally, validated instruments will be applied once prior to the intervention to assess broader health domains, including quality of life (SF-36), physical activity level (International Physical Activity Questionnaire - IPAQ), depressive symptoms (Geriatric Depression Scale), anxiety symptoms (State-Trait Anxiety Inventory), fear of falling (Falls Efficacy Scale International), and pain catastrophizing (Pain Catastrophizing Scale).
Following baseline assessments, participants will be randomly assigned to one of two groups. The intervention group (G1) will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant. The control group (G2) will receive sham TENS, with intensity set at a sub-sensory level without perceptible stimulation. The intervention will consist of a single session lasting 45 minutes.
Analgesic consumption will be evaluated based on the type and quantity of medications used by participants in the 24 hours before and 24 hours after the intervention. These data will be obtained from medical records and prescription information.
This study aims to provide evidence regarding the effectiveness of preoperative TENS as an adjunct to usual care for pain management and its potential influence on physiological and psychological outcomes in older adults with hip fractures.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: ISABEL PAZ, PhD
- Numer telefonu: +55 51 3591-1122
- E-mail: idealmeidapaz@gmail.com
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
- Starszy dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Older adults (male and female) diagnosed with hip fracture
- Age ≥ 60 years
- Admitted to the hospital inpatient unit (HPS)
- Mini-Mental State Examination (MMSE) score ≥ 20
Exclusion Criteria:
- Conditions contraindicating electrical stimulation, such as presence of a pacemaker, significant sensory loss in the lower limbs, or skin lesions at the electrode placement site
- History of neurological or cognitive impairment that may interfere with understanding of the assessments
- Previous treatment with neuromuscular electrical stimulation (NMES) in the lower limb within the last 3 months
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Aktywny komparator: Active TENS
Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant.
|
Active transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity adjusted to the maximum level tolerated by the participant.
|
|
Pozorny komparator: Sham TENS
Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation).
|
Sham transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity set at a sub-sensory level, with no perceptible stimulation.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Pain intensity
Ramy czasowe: Before and immediately after the intervention (single session)
|
Pain intensity will be assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates worst imaginable pain.
Higher scores represent worse outcomes.
|
Before and immediately after the intervention (single session)
|
|
Pressure pain threshold
Ramy czasowe: Before and immediately after the intervention
|
Pressure pain threshold will be measured using a pressure algometer.
|
Before and immediately after the intervention
|
|
Blood pressure
Ramy czasowe: Before and immediately after the intervention
|
Blood pressure will be measured before and after the intervention.
|
Before and immediately after the intervention
|
|
Analgesic consumption
Ramy czasowe: 24 hours before and 24 hours after the intervention
|
Analgesic use will be assessed based on the type and quantity of medications recorded in medical records.
|
24 hours before and 24 hours after the intervention
|
|
Quality of life (SF-36)
Ramy czasowe: Baseline (pre-intervention)
|
Quality of life will be assessed using the Short Form Health Survey (SF-36), ranging from 0 to 100, where higher scores indicate better quality of life.
|
Baseline (pre-intervention)
|
|
Physical activity level (IPAQ)
Ramy czasowe: Baseline
|
Physical activity level will be assessed using the International Physical Activity Questionnaire (IPAQ), expressed in MET-minutes/week.
Higher values indicate higher levels of physical activity.
|
Baseline
|
|
Depressive symptoms
Ramy czasowe: Baseline
|
Depressive symptoms will be assessed using the Geriatric Depression Scale (GDS), ranging from 0 to 15, where higher scores indicate more severe depressive symptoms.
|
Baseline
|
|
Anxiety symptoms
Ramy czasowe: Baseline
|
Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), ranging from 20 to 80, where higher scores indicate greater anxiety levels.
|
Baseline
|
|
Fear of falling
Ramy czasowe: Baseline
|
Fear of falling will be assessed using the Falls Efficacy Scale International (FES-I), ranging from 16 to 64, where higher scores indicate greater concern about falling.
|
Baseline
|
|
Pain catastrophizing
Ramy czasowe: Baseline
|
Pain catastrophizing will be assessed using the Pain Catastrophizing Scale (PCS), ranging from 0 to 52, where higher scores indicate greater levels of catastrophizing.
|
Baseline
|
|
Heart rate
Ramy czasowe: Before and immediately after the intervention
|
Heart rate will be measured before and after the intervention.
|
Before and immediately after the intervention
|
|
Respiratory rate
Ramy czasowe: Before and immediately after the intervention
|
Respiratory rate will be measured before and after the intervention.
|
Before and immediately after the intervention
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- 96034926.1.0000.5338
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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