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How TENS Affects Pain, Medication Use, and Muscle Function in Older Adults With Hip Fractures (TENS-HIP)

4. Mai 2026 aktualisiert von: Isabel de Almeida Paz, University of the Sinos Valley

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

32

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Aktiver Komparator: Active TENS
Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant.
Gerät: Active Transcutaneous Electrical Nerve Stimulation (TENS)
Active transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity adjusted to the maximum level tolerated by the participant.
Schein-Komparator: Sham TENS
Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation).
Gerät: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)
Sham transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity set at a sub-sensory level, with no perceptible stimulation.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Pain intensity
Zeitfenster: 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
Zeitfenster: Before and immediately after the intervention
Pressure pain threshold will be measured using a pressure algometer.
Before and immediately after the intervention
Blood pressure
Zeitfenster: Before and immediately after the intervention
Blood pressure will be measured before and after the intervention.
Before and immediately after the intervention
Analgesic consumption
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Before and immediately after the intervention
Heart rate will be measured before and after the intervention.
Before and immediately after the intervention
Respiratory rate
Zeitfenster: Before and immediately after the intervention
Respiratory rate will be measured before and after the intervention.
Before and immediately after the intervention

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of the Sinos Valley

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

22. Mai 2026

Primärer Abschluss (Geschätzt)

28. Dezember 2026

Studienabschluss (Geschätzt)

28. Januar 2027

Studienanmeldedaten

Zuerst eingereicht

22. April 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

3. Mai 2026

Zuerst gepostet (Tatsächlich)

5. Mai 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

8. Mai 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

4. Mai 2026

Zuletzt verifiziert

1. Mai 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 96034926.1.0000.5338

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

UNENTSCHIEDEN

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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