Musculoskeletal PainTENSNCT04209673
TENS and Perioperative Fracture Patients
An observational study of Musculoskeletal Pain, run by Wake Forest University Health Sciences at 1 site in United States.
Trial summary
This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Musculoskeletal Pain
- What is being tested?
- Multimodal Pain management including TENS unit and Multimodal Pain management not including TENS unit
- How many people
- 205 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jan 2020to 30 Jun 2025
- Phase
- Observational
- 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
Study population: This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.
Who may be able to join
- Operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction
- Injury or deformity of the femur, tibia (plateau, shaft, pilon), or hindfoot and ankle
- Isolated injury
- Age 18 years or older
- Able to provide consent
Who cannot join
- • Unable to provide consent (no use of LAR)
Trial locations and contacts
1 site in 1 country.
United States1 site
Carolinas Medical Center, Department of Orthopaedic Surgery
Charlotte, North Carolina, 28204
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Alleviation in Perioperative Fracture Patients
This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months.
Read the detailed description
Transcutaneous electrical nerve stimulation (TENS) is an affordable and non-invasive option for post-operative analgesia. Broadly, TENS devices deliver pulsed electrical impulses across skin to modulate pain. They are theorized to work through different mechanisms at multiple physiologic levels. Centrally, TENS units activate small-diameter sensory afferents (Aδ nerve fibers), which in turn activate descending pain-inhibitory networks. Peripherally, TENS activation of both large- and small-diameter sensory afferents blocks nociceptive signals to the brain and is instead perceived as TENS-induced paresthesias. Finally, TENS efficacy may also be mediated by µ-opioid, 5-hydroxytryptamine (HT)-1, and 5-HT-2 receptors, particularly at low-frequency electrical activity.2
There are inconclusive results for the adjunctive use of TENS to modulate pain, largely because of a relative paucity of high-quality trials and significant inter-study heterogeneity due to non-standardized protocols. Moreover, most studies within the orthopaedic literature have been concentrated primarily within the total knee arthroplasty (TKA) literature and may have limited generalizability to orthopaedic trauma patients. Some studies have shown a trend towards decreased opioid consumption with the adjunctive use of TENS (vs. placebo-TENS or standard care)3,4 while other studies have shown no difference in pain scores in the post-operative period.5-8 To the investigator's knowledge, only two recent randomized clinical trial (RCT)s have been conducted on non-TKA orthopaedic populations, both of which show promise for the use of TENS postoperatively. One prospective double-blind randomized trial on arthroscopic rotator cuff repairs found a 25% reduction in post-operative opioid consumption when TENS was used adjunctively for pain control .9 Another single-blind prospective RCT on Colles' fractures reported greater postoperative pain improvements in patients receiving TENS vs. placebo.10
There is a growing body of evidence to suggest that TENS therapy can reduce post-operative pain after orthopedic procedures. More high-quality studies are needed to strengthen this suggestion and to characterize specific protocols, populations, and orthopedic conditions for which it might work best. Transcutaneous electrical nerve stimulation, if shown to be effective, stands to serve as an affordable non-opioid, non-invasive option for the safe and effective treatment of pain in the orthopaedic trauma patient population.
TENS units are a non-significant risk device and, therefore, do not require an investigational device exemption (IDE) based upon FDA guidance.15-17 The sensor pads will be placed at the same time as the surgical fixation of the study injury. It does not present a potential serious risk to the health and welfare of patients.
Specific Aim 1: To pilot the use of TENS among a postoperative lower extremity injury population as part of multimodal pain management.
Null Hypothesis (H0): TENS cannot be delivered safely among this population. Alternative Hypothesis (HA): TENS can be delivered safely among this population.
Specific Aim 2: To compare utilization of inpatient and outpatient pain medications of patients treated with TENS and historical controls.
H0: Patients treated with TENS will require the same amount of opioids as historical controls.
HA: Patients treated with TENS will require less opioids (lower morphine milligram equivalent - MME) than historical controls during hospitalization and throughout 3-month follow up.
Specific Aim 3: To compare patient-reported outcomes of patients treated with TENS and historical controls.
H0 1: Patients treated with TENS will experience equivalent patient-reported outcomes as compared to historical controls.
HA 1: Patients treated with TENS will experience greater improvement in patient-reported outcomes (PROMIS 29) relative to baseline as compared to historical controls.
H0 2: Patients treated with TENS will report higher pain scores as compared to historical controls.
HA 2: Patients treated with TENS will report equivalent or lower pain scores as compared to historical controls.
This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.
- Conditions
- Musculoskeletal Pain
- Being tested
- Multimodal Pain management including TENS unit, Multimodal Pain management not including TENS unit
- Medical subject headings
- Musculoskeletal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multimodal Pain management including TENS unitOther
Patient receiving multimodal pain management strategies which includes the use of TENS.
Multimodal Pain management not including TENS unitOther
Patient receiving multimodal pain management strategies which does not includes the use of TENS.
| Study group | Role | What they receive |
|---|---|---|
| Transcutaneous nerve stimulation (TENS) patients | Patients who received a TENS unit after surgery Receives: Other: Multimodal Pain management including TENS unit | |
| No TENS | Historic controls- Patients who did not receive a TENS unit after surgery Receives: Other: Multimodal Pain management not including TENS unit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid use
Total amount of opioid use calculated by converting all opiates to Morphine Milligram Equivalents
Measured: 3 months following TENS unit placement
Secondary outcomes (1)
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
The PROMIS-29 assesses seven health domains: physical function, anxiety, depression, fatigue, sleep disturbance, pain interference, and ability to participate in social roles and activities. Each of the seven domains has four questions which are scored on a five-point Likert scale. The PROMIS-29 scales will be scored using a T-score metric method available at the Assessment Center website (http://assessmentcenter.net). A score of 50 points represents the population average for each scale, and 10 points represent one standard deviation. Higher scores mean more of the specific scale's construct, which may indicate a desirable or an undesirable outcome.
Measured: baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start6 Jan 2020
- Primary completion30 Jun 2025
- Study completion30 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Musculoskeletal PainStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joseph Hsu, MD, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04209673
- Sponsor's protocol ID
- IRB00082259
- Other IDs
- 05-19-16E
- Acronym
- TENS
- Status last verified
- Jun 2025
- First submitted
- 13 Dec 2019
- Last updated
- 8 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
PubMed 24519537Li J, Song Y. Transcutaneous electrical nerve stimulation for postoperative pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Sep;96(37):e8036. doi: 10.1097/MD.0000000000008036.
PubMed 28906393Tedesco D, Gori D, Desai KR, Asch S, Carroll IR, Curtin C, McDonald KM, Fantini MP, Hernandez-Boussard T. Drug-Free Interventions to Reduce Pain or Opioid Consumption After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. JAMA Surg. 2017 Oct 18;152(10):e172872. doi: 10.1001/jamasurg.2017.2872. Epub 2017 Oct 18.
PubMed 28813550Beckwee D, Bautmans I, Swinnen E, Vermet Y, Lefeber N, Lievens P, Vaes P. A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty. SAGE Open Med. 2014 Jun 16;2:2050312114539318. doi: 10.1177/2050312114539318. eCollection 2014.
PubMed 26770730Mahure SA, Rokito AS, Kwon YW. Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial. J Shoulder Elbow Surg. 2017 Sep;26(9):1508-1513. doi: 10.1016/j.jse.2017.05.030. Epub 2017 Jul 20.
PubMed 28735847Lee CH, Lee TY, Her JS, Liao WL, Hsieh CL. Single-Blinded, Randomized Preliminary Study Evaluating the Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Pain in Patients with Colles' Fracture. J Altern Complement Med. 2015 Dec;21(12):754-8. doi: 10.1089/acm.2015.0119. Epub 2015 Oct 23.
PubMed 26496205Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
PubMed 12600800Seymour RB, Leas D, Wally MK, Hsu JR; PRIMUM Group. Prescription reporting with immediate medication utilization mapping (PRIMUM): development of an alert to improve narcotic prescribing. BMC Med Inform Decis Mak. 2016 Aug 22;16(1):111. doi: 10.1186/s12911-016-0352-x.
PubMed 27549364Garland D, Holt P, Harrington JT, Caldwell J, Zizic T, Cholewczynski J. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2007 Jun;15(6):630-7. doi: 10.1016/j.joca.2007.01.004. Epub 2007 Feb 15.
PubMed 17303443Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990 Jun 7;322(23):1627-34. doi: 10.1056/NEJM199006073222303.
PubMed 2140432U. S. Food and Drug Administration/Center for Devices and Radiological Health. (2006). Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies : FDA public health advisory. Silver Spring, MD.
Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
PubMed 26827847Rakel BA, Zimmerman BM, Geasland K, Embree J, Clark CR, Noiseux NO, Callaghan JJ, Herr K, Walsh D, Sluka KA. Transcutaneous electrical nerve stimulation for the control of pain during rehabilitation after total knee arthroplasty: A randomized, blinded, placebo-controlled trial. Pain. 2014 Dec;155(12):2599-2611. doi: 10.1016/j.pain.2014.09.025. Epub 2014 Sep 28.
PubMed 25270585Cella D, Riley W, Stone A, Rothrock N, Reeve B, Yount S, Amtmann D, Bode R, Buysse D, Choi S, Cook K, Devellis R, DeWalt D, Fries JF, Gershon R, Hahn EA, Lai JS, Pilkonis P, Revicki D, Rose M, Weinfurt K, Hays R; PROMIS Cooperative Group. The Patient-Reported Outcomes Measurement Information System (PROMIS) developed and tested its first wave of adult self-reported health outcome item banks: 2005-2008. J Clin Epidemiol. 2010 Nov;63(11):1179-94. doi: 10.1016/j.jclinepi.2010.04.011. Epub 2010 Aug 4.
PubMed 20685078Jones I, Johnson MI. Transcutaneous electrical nerve stimulation. Continuing Education in Anaesthesia Critical Care & Pain. 2009;9(4):130-135.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Alleviation in Perioperative Fracture Patients
- ClinicalTrials.gov ID
- NCT04209673
- Acronym / sponsor ID
- TENS / IRB00082259
- Conditions
- Musculoskeletal Pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Study start
- 6 Jan 2020 (actual)
- Primary completion
- 30 Jun 2025 (actual)
- Study completion
- 30 Jun 2025 (actual)
- First posted
- 24 Dec 2019 (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.
This is a pilot study designed to evaluate the effectiveness of TENS as part of post-operative pain management. Subjects receiving a TENS unit as part of clinical practice will be approached for consent and followed for 12 months.
Detailed description
Transcutaneous electrical nerve stimulation (TENS) is an affordable and non-invasive option for post-operative analgesia. Broadly, TENS devices deliver pulsed electrical impulses across skin to modulate pain. They are theorized to work through different mechanisms at multiple physiologic levels. Centrally, TENS units activate small-diameter sensory afferents (Aδ nerve fibers), which in turn activate descending pain-inhibitory networks. Peripherally, TENS activation of both large- and small-diameter sensory afferents blocks nociceptive signals to the brain and is instead perceived as TENS-induced paresthesias. Finally, TENS efficacy may also be mediated by µ-opioid, 5-hydroxytryptamine (HT)-1, and 5-HT-2 receptors, particularly at low-frequency electrical activity.2
There are inconclusive results for the adjunctive use of TENS to modulate pain, largely because of a relative paucity of high-quality trials and significant inter-study heterogeneity due to non-standardized protocols. Moreover, most studies within the orthopaedic literature have been concentrated primarily within the total knee arthroplasty (TKA) literature and may have limited generalizability to orthopaedic trauma patients. Some studies have shown a trend towards decreased opioid consumption with the adjunctive use of TENS (vs. placebo-TENS or standard care)3,4 while other studies have shown no difference in pain scores in the post-operative period.5-8 To the investigator's knowledge, only two recent randomized clinical trial (RCT)s have been conducted on non-TKA orthopaedic populations, both of which show promise for the use of TENS postoperatively. One prospective double-blind randomized trial on arthroscopic rotator cuff repairs found a 25% reduction in post-operative opioid consumption when TENS was used adjunctively for pain control .9 Another single-blind prospective RCT on Colles' fractures reported greater postoperative pain improvements in patients receiving TENS vs. placebo.10
There is a growing body of evidence to suggest that TENS therapy can reduce post-operative pain after orthopedic procedures. More high-quality studies are needed to strengthen this suggestion and to characterize specific protocols, populations, and orthopedic conditions for which it might work best. Transcutaneous electrical nerve stimulation, if shown to be effective, stands to serve as an affordable non-opioid, non-invasive option for the safe and effective treatment of pain in the orthopaedic trauma patient population.
TENS units are a non-significant risk device and, therefore, do not require an investigational device exemption (IDE) based upon FDA guidance.15-17 The sensor pads will be placed at the same time as the surgical fixation of the study injury. It does not present a potential serious risk to the health and welfare of patients.
Specific Aim 1: To pilot the use of TENS among a postoperative lower extremity injury population as part of multimodal pain management.
Null Hypothesis (H0): TENS cannot be delivered safely among this population. Alternative Hypothesis (HA): TENS can be delivered safely among this population.
Specific Aim 2: To compare utilization of inpatient and outpatient pain medications of patients treated with TENS and historical controls.
H0: Patients treated with TENS will require the same amount of opioids as historical controls.
HA: Patients treated with TENS will require less opioids (lower morphine milligram equivalent - MME) than historical controls during hospitalization and throughout 3-month follow up.
Specific Aim 3: To compare patient-reported outcomes of patients treated with TENS and historical controls.
H0 1: Patients treated with TENS will experience equivalent patient-reported outcomes as compared to historical controls.
HA 1: Patients treated with TENS will experience greater improvement in patient-reported outcomes (PROMIS 29) relative to baseline as compared to historical controls.
H0 2: Patients treated with TENS will report higher pain scores as compared to historical controls.
HA 2: Patients treated with TENS will report equivalent or lower pain scores as compared to historical controls.
This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcutaneous nerve stimulation (TENS) patients | – | Other: Multimodal Pain management including TENS unitPatients who received a TENS unit after surgery |
| No TENS | – | Other: Multimodal Pain management not including TENS unitHistoric controls- Patients who did not receive a TENS unit after surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This will be a prospective observational study of patients undergoing operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction. The study will be conducted at a single Level I trauma center. Enrolled patients will receive TENS postoperatively during hospitalization; TENS units will also be sent home with patients for use throughout recovery. This group will be compared to controls injury-matched from a prospectively collected, historical database on mobility who did not receive treatment with TENS.
Key inclusion criteria (5 listed)
- Operative treatment of lower extremity conditions, including fracture fixation, treatment of nonunion, and deformity correction
- Injury or deformity of the femur, tibia (plateau, shaft, pilon), or hindfoot and ankle
- Isolated injury
- Age 18 years or older
- Able to provide consent
Key exclusion criteria (1 listed)
- • Unable to provide consent (no use of LAR)
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 |
|---|---|---|
| Multimodal Pain management including TENS unitPatient receiving multimodal pain management strategies which includes the use of TENS. | Other | Transcutaneous nerve stimulation (TENS) patients |
| Multimodal Pain management not including TENS unitPatient receiving multimodal pain management strategies which does not includes the use of TENS. | Other | No TENS |
Primary outcome
Opioid use
Time frame: 3 months following TENS unit placement
Total amount of opioid use calculated by converting all opiates to Morphine Milligram Equivalents
1 secondary outcome
Change in patient-reported outcomes measurement information system (PROMIS 29) scores
Time frame: baseline and 3 months
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 8 Jan 2026.
- Background: PubMed 24519537Clarke H, Soneji N, Ko DT, Yun L, Wijeysundera DN. Rates and risk factors for prolonged opioid use after major surgery: population based cohort study. BMJ. 2014 Feb 11;348:g1251. doi: 10.1136/bmj.g1251.
- Background: PubMed 28906393Li J, Song Y. Transcutaneous electrical nerve stimulation for postoperative pain control after total knee arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Sep;96(37):e8036. doi: 10.1097/MD.0000000000008036.
- Background: PubMed 28813550Tedesco D, Gori D, Desai KR, Asch S, Carroll IR, Curtin C, McDonald KM, Fantini MP, Hernandez-Boussard T. Drug-Free Interventions to Reduce Pain or Opioid Consumption After Total Knee Arthroplasty: A Systematic Review and Meta-analysis. JAMA Surg. 2017 Oct 18;152(10):e172872. doi: 10.1001/jamasurg.2017.2872. Epub 2017 Oct 18.
- Background: PubMed 26770730Beckwee D, Bautmans I, Swinnen E, Vermet Y, Lefeber N, Lievens P, Vaes P. A systematic review investigating the relationship between efficacy and stimulation parameters when using transcutaneous electrical nerve stimulation after knee arthroplasty. SAGE Open Med. 2014 Jun 16;2:2050312114539318. doi: 10.1177/2050312114539318. eCollection 2014.
- Background: PubMed 28735847Mahure SA, Rokito AS, Kwon YW. Transcutaneous electrical nerve stimulation for postoperative pain relief after arthroscopic rotator cuff repair: a prospective double-blinded randomized trial. J Shoulder Elbow Surg. 2017 Sep;26(9):1508-1513. doi: 10.1016/j.jse.2017.05.030. Epub 2017 Jul 20.
- Background: PubMed 26496205Lee CH, Lee TY, Her JS, Liao WL, Hsieh CL. Single-Blinded, Randomized Preliminary Study Evaluating the Effect of Transcutaneous Electrical Nerve Stimulation on Postoperative Pain in Patients with Colles' Fracture. J Altern Complement Med. 2015 Dec;21(12):754-8. doi: 10.1089/acm.2015.0119. Epub 2015 Oct 23.
- Background: PubMed 12600800Bjordal JM, Johnson MI, Ljunggreen AE. Transcutaneous electrical nerve stimulation (TENS) can reduce postoperative analgesic consumption. A meta-analysis with assessment of optimal treatment parameters for postoperative pain. Eur J Pain. 2003;7(2):181-8. doi: 10.1016/S1090-3801(02)00098-8.
- Background: PubMed 27549364Seymour RB, Leas D, Wally MK, Hsu JR; PRIMUM Group. Prescription reporting with immediate medication utilization mapping (PRIMUM): development of an alert to improve narcotic prescribing. BMC Med Inform Decis Mak. 2016 Aug 22;16(1):111. doi: 10.1186/s12911-016-0352-x.
- Background: PubMed 17303443Garland D, Holt P, Harrington JT, Caldwell J, Zizic T, Cholewczynski J. A 3-month, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of a highly optimized, capacitively coupled, pulsed electrical stimulator in patients with osteoarthritis of the knee. Osteoarthritis Cartilage. 2007 Jun;15(6):630-7. doi: 10.1016/j.joca.2007.01.004. Epub 2007 Feb 15.
- Background: PubMed 2140432Deyo RA, Walsh NE, Martin DC, Schoenfeld LS, Ramamurthy S. A controlled trial of transcutaneous electrical nerve stimulation (TENS) and exercise for chronic low back pain. N Engl J Med. 1990 Jun 7;322(23):1627-34. doi: 10.1056/NEJM199006073222303.
- BackgroundU. S. Food and Drug Administration/Center for Devices and Radiological Health. (2006). Information Sheet Guidance For IRBs, Clinical Investigators, and Sponsors Significant Risk and Nonsignificant Risk Medical Device Studies : FDA public health advisory. Silver Spring, MD.
- Background: PubMed 26827847Chou R, Gordon DB, de Leon-Casasola OA, Rosenberg JM, Bickler S, Brennan T, Carter T, Cassidy CL, Chittenden EH, Degenhardt E, Griffith S, Manworren R, McCarberg B, Montgomery R, Murphy J, Perkal MF, Suresh S, Sluka K, Strassels S, Thirlby R, Viscusi E, Walco GA, Warner L, Weisman SJ, Wu CL. Management of Postoperative Pain: A Clinical Practice Guideline From the American Pain Society, the American Society of Regional Anesthesia and Pain Medicine, and the American Society of Anesthesiologists' Committee on Regional Anesthesia, Executive Committee, and Administrative Council. J Pain. 2016 Feb;17(2):131-57. doi: 10.1016/j.jpain.2015.12.008.
- 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.
Joseph Hsu, MD principal investigator
Wake Forest University Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Musculoskeletal Pain, run by Wake Forest University Health Sciences 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 5 inclusion and 1 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 8 Jan 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 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?
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?
Opioid use (time frame: 3 months following TENS unit placement). 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 NCT04209673, which also lists 15 linked publications.
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 Jan 2026.