Hip FracturesTENS-HIPNCT07567339
How TENS Affects Pain, Medication Use, and Muscle Function in Older Adults With Hip Fractures
A study testing Active Transcutaneous Electrical Nerve Stimulation (TENS) in people with Hip Fractures and Femoral Neck Fractures, run by University of the Sinos Valley.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Hip Fractures, Femoral Neck Fractures, Intertrochanteric Femur Fracture
- What is being tested?
- Active Transcutaneous Electrical Nerve Stimulation (TENS)
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 32 participants
- Where
- No sites listed yet
- Study dates
- 22 May 2026to 28 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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)?
Read more
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.
Read the detailed description
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.
- Being tested
- Active Transcutaneous Electrical Nerve Stimulation (TENS), Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)
- Keywords
- Hip Fractures, TENS, PAIN
- Medical subject headings
- Hip Fractures, Femoral Neck Fractures, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Active comparator | Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant. Receives: 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). Receives: Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Before and immediately after the intervention (single session)
Pressure pain threshold
Pressure pain threshold will be measured using a pressure algometer.
Measured: Before and immediately after the intervention
Blood pressure
Blood pressure will be measured before and after the intervention.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline
Heart rate
Heart rate will be measured before and after the intervention.
Measured: Before and immediately after the intervention
Respiratory rate
Respiratory rate will be measured before and after the intervention.
Measured: Before and immediately after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2026
- Study start22 May 2026 (estimated)
- Primary completion28 Dec 2026 (estimated)
- Study completion28 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hip FracturesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of the Sinos Valley
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Isabel de Almeida Paz, University of the Sinos Valley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07567339
- Sponsor's protocol ID
- 96034926.1.0000.5338
- Acronym
- TENS-HIP
- Status last verified
- May 2026
- First submitted
- 22 Apr 2026
- Last updated
- 8 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07567339
- Acronym / sponsor ID
- TENS-HIP / 96034926.1.0000.5338
- Keywords
- Hip Fractures, TENS, PAIN
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- University of the Sinos ValleyUniversity, hospital or other
- Study start
- 22 May 2026 (estimated)
- Primary completion
- 28 Dec 2026 (estimated)
- Study completion
- 28 Jan 2027 (estimated)
- First posted
- 5 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Active comparator | Device: Active Transcutaneous Electrical Nerve Stimulation (TENS)Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant. |
| Sham TENS | Sham comparator | Device: Sham Transcutaneous Electrical Nerve Stimulation (Sham TENS)Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation). |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Active TENS |
| 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. | Device | Sham TENS |
Primary outcome
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.
Pressure pain threshold
Time frame: Before and immediately after the intervention
Pressure pain threshold will be measured using a pressure algometer.
Blood pressure
Time frame: Before and immediately after the intervention
Blood pressure will be measured before and after the intervention.
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.
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.
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.
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.
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.
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.
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.
Heart rate
Time frame: Before and immediately after the intervention
Heart rate will be measured before and after the intervention.
Respiratory rate
Time frame: Before and immediately after the intervention
Respiratory rate will be measured before and after the intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Active Transcutaneous Electrical Nerve Stimulation (TENS) in people with Hip Fractures and Femoral Neck Fractures, run by University of the Sinos Valley.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ISABEL PAZ, PhD (+55 51 3591-1122, idealmeidapaz@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: Before and immediately after the intervention (single session)). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2026; AzTrials last refreshed its copy on 26 Oct 2026.