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

4. maj 2026 opdateret af: 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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

32

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Active TENS
Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant.
Enhed: 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.
Sham-komparator: Sham TENS
Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation).
Enhed: 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.

Hvad måler undersøgelsen?

Primære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of the Sinos Valley

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

22. maj 2026

Primær færdiggørelse (Anslået)

28. december 2026

Studieafslutning (Anslået)

28. januar 2027

Datoer for studieregistrering

Først indsendt

22. april 2026

Først indsendt, der opfyldte QC-kriterier

3. maj 2026

Først opslået (Faktiske)

5. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

4. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 96034926.1.0000.5338

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