Postoperative PainNCT01046695
Evaluating Transcutaneous Electrical Nerve Stimulation for Postoperative Pain After Video-Assisted Thoracotomy Surgery
A study testing TENS Unit in people with Postoperative Pain, run by Mayo Clinic at 1 site in United States.
Trial summary
We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine if: Nurses will be able to apply TENS effectively and in a timely manner to post VATS patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- TENS Unit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Men and women age 18-100 able to give informed consent.
- Able to speak and understand English.
Who cannot join
- Too confused to provide data or not extubated within 48 hours after surgery.
- Unable to speak and understand English.
- Patients with active internal pacer wires, demand type implanted pacemakers or defibrillator.
- Transplant patients.
- Children, prisoners, any woman who is pregnant.
- Patients that are non-scheduled surgery cases or occurring Saturday or Sunday.
Show all 9Show fewer
- Ventricular Assisted Device (VAD) patients.
- Know allergies or intolerance to TENS electrodes.
- Patients who have had the Da Vinci robotic assisted minimally invasive procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Postoperative Pain After Video-Assisted Thoracotomy Surgery (VATS)
We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine if:
- Nurses will be able to apply TENS effectively and in a timely manner to post VATS patients.
- Use of TENS immediately after thoracic surgery and for the first 48 hours will add to patient's pain control.
- Tens will reduce medication use.
- Tens will reduce nausea and vomiting.
Read the detailed description
Video-Assisted Thoracotomy (VATS) patient's post procedure pain is a significant problem that may delay the recovery of thoracic surgery patients. Without adequate control of pain, the patient's mobilization and ability to participate in bronchial hygiene is compromised increasing the risk for pulmonary complications and inhibiting the body's natural healing ability. When acute post VATS pain is poorly controlled, the incidence of chronic post VATS pain six months or longer after the surgery increases. Post-operative pain is controlled largely through the use of pain medications delivered by a variety of routes including: epidural, intravenous, and when able, oral. Medications used include opioids which have side effects such as nausea, dizziness, drowsiness and constipation that may further delay the patient's recovery and prolong the hospital stay.
Transcutaneous Electrical Nerve Stimulation (TENS) is a method of pain relief that uses cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. Treating pain with TENS results in the patient having a reduced perception of pain. The effectiveness of TENS is based on two mechanisms: 1) the gate control theory of pain relief where stimulation of myelinated sensory fibers disrupts neuronal processing in the substantia gelatinosa of the spinal cord, and 2) the stimulation-induced release of endogenous opioids, both in the central nervous system and the general circulation. The present practice for obtaining and applying a TENS unit on a patient for pain relief requires consultation with Physical Therapy who will come and assess the patient and then apply the TENS unit and make recommendations for settings and therapy. This process limits the response to only daytime and often results in a delay in initiation of treatment. After providing education and training it is anticipated that nurses could successfully apply a TENS unit and initiate therapy early in the immediate post operative period. The more timely application of a TENS unit to a post VATS patient could improve pain management outcomes for this population.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain by nurses trained in TENS therapy. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The 5 program options available included: #1. Alternate Ramped Burst (ARB) (Rate = 100 pps; Ramp Up Time = 0.5s; On Time = 5s; Off Time = 6s). #2. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again. #3. Modulated Amplitude (MA) (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). #4. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again). #5 Modulated Amplitude, MA (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation. Five minutes after initiation of TENS therapy and every hour there after - while patient was awake- for a total of 48 hours, the patient was reassessed by nursing staff and TENS settings were adjusted for patient comfort and pain control.
- Conditions
- Postoperative Pain
- Being tested
- TENS Unit
- Keywords
- VATS, Video-Assisted Thoracotomy, Thoracic Surgery, Video-Assisted
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENS UnitDevice
Also called Transcutaneous Electrical Nerve Stimulation unit
TENS is a method of pain relief that uses a battery operated electronic device with cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. The TENS Unit is a low voltage system that will only be used to a level to create alternative to pain sensation and will not create muscle response.
| Study group | Role | What they receive |
|---|---|---|
| TENS Unit | Active comparator | This arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation. Receives: Device: TENS Unit |
| Control Arm | No intervention | This arm will have standard care for their post operative pain control. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean Pain Score
Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.
Measured: hour 1 to hour 48 after awakening from video-assisted thoracic surgery
Secondary outcomes (2)
Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours
As subjects could have been prescribed many different analgesics, the amount of pain medication was converted to the standard oral morphine equivalents (OME), so that the mean dose needed could be compared.
Measured: 24 hours and 48 hours after awakening from video-assisted thoracic surgery
Satisfaction With Pain Control at 48 Hours
Pain control was measured by using a Visual Analog Scale (VAS) with a range from 0-10; with 0 being very satisfied and 10 being very dissatisfied.
Measured: 48 hours after awakening from video-assisted thoracic surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2010 (estimated)
- Study startMar 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Deborah Engen, Mayo Clinic
- Investigators
- Deborah J. Engen, O.T., Principal investigator, Mayo ClinicDietlind L. Wahner-Roedler, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01046695
- Sponsor's protocol ID
- 10-000141
- Status last verified
- Dec 2012
- First submitted
- 11 Jan 2010
- Last updated
- 19 Dec 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
PubMed 25935320
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Postoperative Pain After Video-Assisted Thoracotomy Surgery (VATS)
- ClinicalTrials.gov ID
- NCT01046695
- Acronym / sponsor ID
- 10-000141
- Conditions
- Postoperative Pain
- Keywords
- VATS, Video-Assisted Thoracotomy, Thoracic Surgery, Video-Assisted
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Mar 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Jan 2010 (estimated)
- Results
- Posted 11 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
We propose to evaluate the use of Transcutaneous Electrical Nerve Stimulation (TENS) in patients having undergone Video-Assisted Thoracotomy Surgery (VATS) with the aim to determine if:
- Nurses will be able to apply TENS effectively and in a timely manner to post VATS patients.
- Use of TENS immediately after thoracic surgery and for the first 48 hours will add to patient's pain control.
- Tens will reduce medication use.
- Tens will reduce nausea and vomiting.
Detailed description
Video-Assisted Thoracotomy (VATS) patient's post procedure pain is a significant problem that may delay the recovery of thoracic surgery patients. Without adequate control of pain, the patient's mobilization and ability to participate in bronchial hygiene is compromised increasing the risk for pulmonary complications and inhibiting the body's natural healing ability. When acute post VATS pain is poorly controlled, the incidence of chronic post VATS pain six months or longer after the surgery increases. Post-operative pain is controlled largely through the use of pain medications delivered by a variety of routes including: epidural, intravenous, and when able, oral. Medications used include opioids which have side effects such as nausea, dizziness, drowsiness and constipation that may further delay the patient's recovery and prolong the hospital stay.
Transcutaneous Electrical Nerve Stimulation (TENS) is a method of pain relief that uses cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. Treating pain with TENS results in the patient having a reduced perception of pain. The effectiveness of TENS is based on two mechanisms: 1) the gate control theory of pain relief where stimulation of myelinated sensory fibers disrupts neuronal processing in the substantia gelatinosa of the spinal cord, and 2) the stimulation-induced release of endogenous opioids, both in the central nervous system and the general circulation. The present practice for obtaining and applying a TENS unit on a patient for pain relief requires consultation with Physical Therapy who will come and assess the patient and then apply the TENS unit and make recommendations for settings and therapy. This process limits the response to only daytime and often results in a delay in initiation of treatment. After providing education and training it is anticipated that nurses could successfully apply a TENS unit and initiate therapy early in the immediate post operative period. The more timely application of a TENS unit to a post VATS patient could improve pain management outcomes for this population.
Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain by nurses trained in TENS therapy. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The 5 program options available included: #1. Alternate Ramped Burst (ARB) (Rate = 100 pps; Ramp Up Time = 0.5s; On Time = 5s; Off Time = 6s). #2. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again. #3. Modulated Amplitude (MA) (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). #4. Simple Modulated Pulse (SMP) (Rate = 125 pps; Cycle Time = 12s; Span Percentage = 40%; Rate stays in the 2-10 pps range for 1/3 of the cycle time (4 seconds) as the rate modulates down to 2 pulses per second (pps) and then back up again). #5 Modulated Amplitude, MA (Rate = 125 pps; Cycle Time = 1s; Span Percentage = 60%). The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation. Five minutes after initiation of TENS therapy and every hour there after - while patient was awake- for a total of 48 hours, the patient was reassessed by nursing staff and TENS settings were adjusted for patient comfort and pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TENS Unit | Active comparator | Device: TENS UnitThis arm will be adding the use of the TENS unit for 48 hours in addition to standard care for their post operative pain control. Patient's primary area of postoperative pain was determined by nursing personnel. Four electrodes were placed on or around the area of maximum pain. The TENS unit was turned on, 1 of 5 frequency patterns selected and the impulse turned up until the patient could feel the impulse. The location of the electrodes, the pattern, and/or the intensity of the TENS unit were adjusted until the patient achieved maximum comfort with the sensation. |
| Control Arm | No intervention | –This arm will have standard care for their post operative pain control. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Men and women age 18-100 able to give informed consent.
- Able to speak and understand English.
Key exclusion criteria (9 listed)
- Too confused to provide data or not extubated within 48 hours after surgery.
- Unable to speak and understand English.
- Patients with active internal pacer wires, demand type implanted pacemakers or defibrillator.
- Transplant patients.
- Children, prisoners, any woman who is pregnant.
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 |
|---|---|---|
| TENS UnitAlso: Transcutaneous Electrical Nerve Stimulation unitTENS is a method of pain relief that uses a battery operated electronic device with cutaneously applied electrodes that deliver electrical signals to peripheral nerves through the intact skin. The TENS Unit is a low voltage system that will only be used to a level to create alternative to pain sensation and will not create muscle response. | Device | TENS Unit |
Primary outcome
Mean Pain Score
Time frame: hour 1 to hour 48 after awakening from video-assisted thoracic surgery
Pain was measured by using the Visual Analog Scale (VAS) with a range from 1-10; with 0 being no pain and 10 being severe pain. Pain scores were measured from hour 1 to hour 48 for each patient. Some scores were missed when patients were asleep. In these cases, the previous score was used.
2 secondary outcomes
Mean Opioid Use, Converted Into Oral Morphine Equivalents (OME) at 24 and 48 Hours
Time frame: 24 hours and 48 hours after awakening from video-assisted thoracic surgery
Satisfaction With Pain Control at 48 Hours
Time frame: 48 hours after awakening from video-assisted thoracic surgery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25935320Engen DJ, Carns PE, Allen MS, Bauer BA, Loehrer LL, Cha SS, Chartrand CM, Eggler EJ, Cutshall SM, Wahner-Roedler DL. Evaluating efficacy and feasibility of transcutaneous electrical nerve stimulation for postoperative pain after video-assisted thoracoscopic surgery: A randomized pilot trial. Complement Ther Clin Pract. 2016 May;23:141-8. doi: 10.1016/j.ctcp.2015.04.002. Epub 2015 Apr 20.
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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.
Deborah J. Engen, O.T. principal investigator
Mayo Clinic
Dietlind L. Wahner-Roedler, M.D. principal investigator
Mayo Clinic
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 Unit in people with Postoperative Pain, run by Mayo Clinic at 1 site in United States.
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 2 inclusion and 9 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 19 Dec 2012. 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 United States. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean Pain Score (time frame: hour 1 to hour 48 after awakening from video-assisted thoracic surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01046695, which also lists 1 linked publication.
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 19 Dec 2012.