How TENS Affects Pain, Medication Use, and Muscle Function in Older Adults With Hip Fractures
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity of the Sinos Valley
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 design
Design model
Parallel
Treatments tested in this trial
Active Transcutaneous Electrical Nerve Stimulation (TENS)
DeviceActive 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)
DeviceSham transcutaneous electrical nerve stimulation (TENS) will be applied for 45 minutes, with intensity set at a sub-sensory level, with no perceptible stimulation.
Treatment groups
32 Participants
are divided into 2 treatment groupsGroup A: Active TENSActive comparator 1 intervention
Group B: Sham TENSSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Before and immediately after the intervention (single session)2
Pressure pain threshold
Pressure pain threshold will be measured using a pressure algometer.
Time frame
Before and immediately after the intervention3
Blood pressure
Blood pressure will be measured before and after the intervention.
Time frame
Before and immediately after the intervention4
Analgesic consumption
Analgesic use will be assessed based on the type and quantity of medications recorded in medical records.
Time frame
24 hours before and 24 hours after the interventionLocations
Sponsors and contacts
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Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: