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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active TENS | Active Comparator | Group 1 will receive active TENS, with intensity adjusted to the maximum level tolerated by the participant. |
|
| Sham TENS | Sham Comparator | Group 2 will receive sham TENS, with intensity adjusted to a sub-sensory level (no perceptible stimulation). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| ISABEL PAZ, PhD | Contact | +55 51 3591-1122 | idealmeidapaz@gmail.com |
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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.
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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.
| 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. |
|
| 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 |
| ID | Term |
|---|---|
| D006620 | Hip Fractures |
| D005265 | Femoral Neck Fractures |
| D010146 | Pain |
| ID | Term |
|---|---|
| D005264 | Femoral Fractures |
| D050723 | Fractures, Bone |
| D014947 | Wounds and Injuries |
| D025981 | Hip Injuries |
| D007869 | Leg Injuries |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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