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

4 mei 2026 bijgewerkt door: 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.

Studie Overzicht

Toestand

Nog niet aan het werven

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Geschat)

32

Fase

  • Niet toepasbaar

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Gerandomiseerd
  • Interventioneel model: Parallelle opdracht
  • Masker: Enkel

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Actieve vergelijker: Active TENS
Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant.
Apparaat: 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-vergelijker: Sham TENS
Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation).
Apparaat: 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.

Wat meet het onderzoek?

Primaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of the Sinos Valley

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Geschat)

22 mei 2026

Primaire voltooiing (Geschat)

28 december 2026

Studie voltooiing (Geschat)

28 januari 2027

Studieregistratiedata

Eerst ingediend

22 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

3 mei 2026

Eerst geplaatst (Werkelijk)

5 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

8 mei 2026

Laatste update ingediend die voldeed aan QC-criteria

4 mei 2026

Laatst geverifieerd

1 mei 2026

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • 96034926.1.0000.5338

Plan Individuele Deelnemersgegevens (IPD)

Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?

ONBESLIST

Informatie over medicijnen en apparaten, studiedocumenten

Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel

Nee

Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct

Nee

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