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NCT Number: NCT07567339

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

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.

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Key information

Conditions

Hip Fractures Femoral Fractures Femoral Neck Fractures Fractures, Bone Hip Injuries Intertrochanteric Femur Fracture Leg Injuries Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active Transcutaneous Electrical Nerve Stimulation (TENS)

Device

Active transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity adjusted to the maximum level tolerated by the participant.

Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)

Device

Sham transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity set at a sub-sensory level, with no perceptible stimulation.

Primary outcomes

  1. Pain intensity

    Time frame: 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.

  2. Pressure pain threshold

    Time frame: Before and immediately after the intervention

    Pressure pain threshold will be measured using a pressure algometer.

  3. Blood pressure

    Time frame: Before and immediately after the intervention

    Blood pressure will be measured before and after the intervention.

  4. Analgesic consumption

    Time frame: 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.

  5. Quality of life (SF-36)

    Time frame: 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.

  6. Physical activity level (IPAQ)

    Time frame: 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.

  7. Depressive symptoms

    Time frame: 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.

  8. Anxiety symptoms

    Time frame: Baseline

    Anxiety will be assessed using the State-Trait Anxiety Inventory (STAI), ranging from 20 to 80, where higher scores indicate greater anxiety levels.

  9. Fear of falling

    Time frame: 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.

  10. Pain catastrophizing

    Time frame: 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.

  11. Heart rate

    Time frame: Before and immediately after the intervention

    Heart rate will be measured before and after the intervention.

  12. Respiratory rate

    Time frame: Before and immediately after the intervention

    Respiratory rate will be measured before and after the intervention.

Study contacts

Contact information is provided by the study sponsor or research team.

ISABEL PAZ, PhD

CONTACT

[email protected]

+55 51 3591-1122

Sponsors and collaborators

Lead sponsor

University of the Sinos Valley

Other

Registry information

Official study title

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

Acronym: TENS-HIP

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 5, 2026
Registry last updated
May 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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