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

NCT07567339 | Not Yet Recruiting

• 1 other identifier: 96034926.1.0000.5338
• Study Type: interventional
• Target: 32
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hip Fractures (ICD-10 72.01-72.2); Hip Fractures (i.e. Femoral Neck or Intertrochanteric Hip Fractures); Hip Fractures

Keywords

Hip Fractures; TENS; Pain management; Preoperative pain

Outcome Measures

Primary Outcomes (12)

• Pain intensity

  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

  Pressure pain threshold will be measured using a pressure algometer.

  Before and immediately after the intervention

• Blood pressure

  Blood pressure will be measured before and after the intervention.

  Before and immediately after the intervention

• Analgesic consumption

  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)

  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)

  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

  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

  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

  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

  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

  Heart rate will be measured before and after the intervention.

  Before and immediately after the intervention

• Respiratory rate

  Respiratory rate will be measured before and after the intervention.

  Before and immediately after the intervention

Study Arms (2)

Active TENS

ACTIVE COMPARATOR

Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant.

Device: Active Transcutaneous Electrical Nerve Stimulation (TENS)

Sham TENS

SHAM COMPARATOR

Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation).

Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)

Interventions

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.

Active TENS

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.

Sham TENS

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of the Sinos Valley: lead

MeSH Terms

Conditions

Hip Fractures; Agnosia

Condition Hierarchy (Ancestors)

Femoral Fractures; Fractures, Bone; Wounds and Injuries; Hip Injuries; Leg Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

ISABEL PAZ, PhD

CONTACT

+55 51 3591-1122; idealmeidapaz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participant randomization will be performed using a computer-generated random sequence. Allocation concealment will be ensured using opaque, sealed, and sequentially numbered envelopes, which will be opened only at the time of the intervention. The outcome assessor will remain blinded to group allocation to minimize bias during data collection.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants will be randomly assigned to one of two parallel groups. One group will receive active TENS, while the other group will receive sham TENS. Each participant will receive only one intervention, and no crossover between groups will occur.

Study Record Dates

• First Submitted: April 22, 2026
• First Posted: May 5, 2026
• Study Start (Estimated): May 22, 2026
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): January 28, 2027
• Last Updated: May 5, 2026

Record last verified: 2026-05