Hip FracturesNCT05939804
The Effect of TENS on Pain and Analgesic Consumption
A study testing TENS in people with Hip Fractures and Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The surgical treatment of an individual with osteoarthritis and hip fracture is provided by hip replacement surgery. While restructuring the joint surfaces with surgery, it is aimed to provide both hip joint movements and to treat pain. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hip Fractures, Pain, Postoperative, Analgesia
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2024to 1 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- be over 18 years old
- hip replacement insertion
- not have a pacemaker or arrhythmia
- no history of pain, alcohol use or substance abuse
- no history of pain, alcohol use or substance abuse
- no history of pain, alcohol use or substance abuse
Show all 11Show fewer
- no history of psychiatric illness
- no history of metastatic disease
- being conscious, able to speak
- No barriers to the application of TENS; no postoperative complications
- being I, II and III in the ASA classification of the American Society of Anesthesiology, agreeing to participate in the study.
Who cannot join
- having a history of epilepsy
- Using analgesics at least 1 hour before TENS is applied
- the presence of a wound in the area where the electrode will be placed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of TENS on Pain and Analgesic Consumption After Total Hip Replacement
The surgical treatment of an individual with osteoarthritis and hip fracture is provided by hip replacement surgery. While restructuring the joint surfaces with surgery, it is aimed to provide both hip joint movements and to treat pain. Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she/ he is with the patient for 24 hours. When the literature is examined, it is seen that the number of studies showing the effectiveness of TENS application in patients who underwent hip prosthesis, where studies were conducted with patients with knee gonarthrosis, is limited. In this direction, the aim of the study is to examine the effect of TENS application on patients' pain level and analgesic use in patients undergoing hip replacement.
Read the detailed description
Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. Postoperative pain can be treated with narcotics, which is usually accompanied by adverse side effects such as nausea, vomiting, delirium, constipation and gastrointestinal dysfunction. In general, narcotic use should be limited, especially in the elderly, due to the higher incidence of these side effects in this population. However, poor pain management in the elderly not only hinders rehabilitation, but may also lead to other adverse consequences such as tachycardia, increased myocardial oxygen demand, cardiac ischemia and higher risk of post-operative delirium.
Therefore, it is recommended to use non-pharmacological methods as well as pharmacological methods to manage postoperative pain. In the TENS technique, which is one of the non-pharmacological methods used in pain management, a controlled and low-voltage electric current is applied to the nervous system through the skin, and it is seen that the method is used as an effective and non-invasive treatment option in many painful conditions such as neuropathic pain, pain due to osteoarthritis, and post-operative pain. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she is with the patient for 24 hours. Considering the nursing studies conducted abroad on the application of TENS, it is seen that the nurses apply TENS as a non-pharmacological method in the treatment of pain and train the patients on the application of TENS at home.
- Conditions
- Hip Fractures, Pain, Postoperative, Analgesia
- Being tested
- TENS
- Keywords
- Hip Replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Analgesia
- Medical subject headings
- Hip Fractures, Pain, Postoperative, Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher.
| Study group | Role | What they receive |
|---|---|---|
| TENS group | Experimental | 60 minutes of TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher. After the procedure, the amount of analgesic consumed by the experimental group in the first hour will be questioned and recorded. Receives: Device: TENS |
| Control group | No intervention | The routine treatment and care of the control group will not be interfered with. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the pain level using the VAS.
Reducing the pain level of patients undergoing hip replacement by applying TENS.
A value of 0 on the scale means that the patient does not experience pain, and a value of 10 means that he experiences pain at the most severe level
Measured: 48 hour
Change in analgesic consumption
Changing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 days after the surgery will be learned by using the questionnaire.
Measured: 48 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2023
- Study start1 May 2024
- Primary completion1 Dec 2025
- Study completion1 Dec 2025
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.
- More trials run by Cukurova UniversityThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Acelya Turkmen, Cukurova University
- Investigators
- Açelya Türkmen, PhD, Principal investigator, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05939804
- Sponsor's protocol ID
- CU-SBF-AT-05
- Status last verified
- Dec 2025
- First submitted
- 3 Jul 2023
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of TENS on Pain and Analgesic Consumption After Total Hip Replacement
- ClinicalTrials.gov ID
- NCT05939804
- Acronym / sponsor ID
- CU-SBF-AT-05
- Conditions
- Hip Fractures, Pain, Postoperative, Analgesia
- Keywords
- Hip Replacement, Transcutaneous Electrical Nerve Stimulation, Pain, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- 1 May 2024 (actual)
- Primary completion
- 1 Dec 2025 (actual)
- Study completion
- 1 Dec 2025 (actual)
- First posted
- 11 Jul 2023 (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 surgical treatment of an individual with osteoarthritis and hip fracture is provided by hip replacement surgery. While restructuring the joint surfaces with surgery, it is aimed to provide both hip joint movements and to treat pain. Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she/ he is with the patient for 24 hours. When the literature is examined, it is seen that the number of studies showing the effectiveness of TENS application in patients who underwent hip prosthesis, where studies were conducted with patients with knee gonarthrosis, is limited. In this direction, the aim of the study is to examine the effect of TENS application on patients' pain level and analgesic use in patients undergoing hip replacement.
Detailed description
Intense perioperative pain after hip replacement is common due to inflammatory agents and surgical intervention (eg, involvement of soft tissue and sensory nerves). Inadequately treated acute postoperative pain causes longer hospital stay, limited and delayed bed rest, decreased compliance with physical therapy, and an increased incidence of postoperative complications. Postoperative pain can be treated with narcotics, which is usually accompanied by adverse side effects such as nausea, vomiting, delirium, constipation and gastrointestinal dysfunction. In general, narcotic use should be limited, especially in the elderly, due to the higher incidence of these side effects in this population. However, poor pain management in the elderly not only hinders rehabilitation, but may also lead to other adverse consequences such as tachycardia, increased myocardial oxygen demand, cardiac ischemia and higher risk of post-operative delirium.
Therefore, it is recommended to use non-pharmacological methods as well as pharmacological methods to manage postoperative pain. In the TENS technique, which is one of the non-pharmacological methods used in pain management, a controlled and low-voltage electric current is applied to the nervous system through the skin, and it is seen that the method is used as an effective and non-invasive treatment option in many painful conditions such as neuropathic pain, pain due to osteoarthritis, and post-operative pain. It is thought that this method, which can be effective in the pain control of the patient, will be beneficial for the patient both physiologically and psychologically by reducing pain and discomfort. The most important advantage of TENS; It can be easily applied by nurses and easily taught to patients or families. The nurse has a great role in the follow-up of the patient after the surgery, as she is with the patient for 24 hours. Considering the nursing studies conducted abroad on the application of TENS, it is seen that the nurses apply TENS as a non-pharmacological method in the treatment of pain and train the patients on the application of TENS at home.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS group | Experimental | Device: TENS60 minutes of TENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher. After the procedure, the amount of analgesic consumed by the experimental group in the first hour will be questioned and recorded. |
| Control group | No intervention | –The routine treatment and care of the control group will not be interfered with. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- be over 18 years old
- hip replacement insertion
- not have a pacemaker or arrhythmia
- no history of pain, alcohol use or substance abuse
- no history of pain, alcohol use or substance abuse
Key exclusion criteria (3 listed)
- having a history of epilepsy
- Using analgesics at least 1 hour before TENS is applied
- the presence of a wound in the area where the electrode will be placed.
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 |
|---|---|---|
| TENSTENS will be applied to the experimental group on the 0th and 1st days after the surgery, and the pain assessment at the time of movement/rest before and after the procedure will be made by the researcher. | Device | TENS group |
Primary outcome
Change in the pain level using the VAS.
Time frame: 48 hour
Reducing the pain level of patients undergoing hip replacement by applying TENS. A value of 0 on the scale means that the patient does not experience pain, and a value of 10 means that he experiences pain at the most severe level
Change in analgesic consumption
Time frame: 48 hour
Changing analgesic consumption of patients by applying TENS. The analgesic consumption in the first 2 days after the surgery will be learned by using the questionnaire.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Açelya Türkmen, PhD principal investigator
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Hip Fractures and Pain, Postoperative, run by Cukurova University at 1 site in Turkey (Türkiye).
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 11 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: finished, as of the sponsor's last update on 15 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the pain level using the VAS. (time frame: 48 hour). The study lists 2 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 15 Sep 2026.