TENS Unit for Pain After Abortion

Overseen By Shani Ma, MD

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Queen's Medical Center

Must not be taking: Misoprostol, Mifepristone

Disqualifiers: Pacemakers, Epilepsy, Cancer, others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 16-24 hours

36 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a TENS unit, a non-drug pain relief device, can reduce pain during and after laminaria placement, a procedure involved in some second-trimester abortions. Participants will use either the TENS unit or a placebo to compare their effects on pain relief. This trial may suit those planning to undergo laminaria insertion for a D&E procedure, who are comfortable using a TENS unit, and can communicate via text and online surveys. As an unphased trial, it offers participants the chance to contribute to understanding non-drug pain relief options.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, you cannot have used certain medications like misoprostol or mifepristone within 48 hours before the procedure.

What prior data suggests that this TENS unit is safe for pain relief after abortion?

Research has shown that the TENS unit is generally safe for pain relief, with most people tolerating it well. For instance, a study on pain management during various types of abortions used the TENS unit without major problems. Most users did not experience serious side effects and found it effective for pain relief. This suggests that the TENS unit is a safe choice for many who wish to manage pain without medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The TENS unit is unique because it offers a non-drug option for managing pain after an abortion. Unlike standard treatments, which often involve medications like NSAIDs or opioids, the TENS unit uses electrical nerve stimulation to provide relief. This method is appealing because it avoids the side effects and potential dependencies associated with pain medications. Researchers are excited about the TENS unit because it could offer a safe, effective, and non-invasive alternative for pain relief.

What evidence suggests that the TENS unit is effective for pain relief after abortion?

This trial will compare the effectiveness of a TENS unit with a placebo for pain relief after abortion. Studies have shown that TENS, which stands for Transcutaneous Electrical Nerve Stimulation, can help reduce pain. One study found that using TENS lowered the highest pain levels within 8 hours after taking misoprostol, a drug often used in medical procedures. Another study found that TENS served as a good alternative to IV sedation for managing pain during early-stage abortions. However, a different trial showed that TENS did not outperform a fake treatment in reducing pain during early-stage procedures. Overall, TENS is considered a useful non-drug option for pain relief in various situations. ^{2 4 6 7 8}

Who Is on the Research Team?

Melissa Natavio, MD, MPH

Principal Investigator

Complex Family Planning, The Queens Medical Center, Department of Obstetrics, Gynecology, and Womens Health

Are You a Good Fit for This Trial?

This trial is for individuals undergoing laminaria placement as part of a second-trimester termination of pregnancy, seeking non-medication pain relief. Specific eligibility details are not provided, but typically include being in good health and providing informed consent.

Inclusion Criteria

I can send texts and complete surveys online.

Capability to read and understand directions for using a TENS unit

Capability to operate a TENS unit according to provided directions

Exclusion Criteria

Prior use of TENS unit

I don't have a pacemaker, epilepsy, bleeding disorders, cancer, or use transdermal drug patches.

Inability to complete the informed consent in English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive either a TENS unit or placebo during the interval between osmotic dilator placement and D&E procedure

16-24 hours

1 visit (in-person)

Follow-up

Participants are monitored for pain management satisfaction and analgesic use after the procedure

1 week

What Are the Treatments Tested in This Trial?

Interventions

• TENS Unit

Trial Overview The study investigates if a TENS unit, which is a device that delivers small electrical pulses to the body for pain relief, can reduce discomfort during and after laminaria insertion compared to a placebo (inactive treatment).

How Is the Trial Designed?

Group I: TENS unit Active Control 1 Intervention

Group II: Placebo Placebo Group 1 Intervention

TENS Unit is already approved in United States for the following indications:

Approved in United States as TENS Unit for:

• Pain management during IUD insertion
• Analgesia

Who Is Running the Clinical Trial?

Queen's Medical Center

Lead Sponsor

Trials

24

Recruited

4,900+

University of Hawaii Foundation

Collaborator

Trials

2

Recruited

60+

Published Research Related to This Trial

A systematic review of 19 randomized controlled trials (RCTs) on transcutaneous electrical nerve stimulation (TENS) for chronic pain found that while active TENS showed positive analgesic outcomes in 10 out of 15 studies compared to inactive controls, the overall evidence is inconclusive due to poor methodological quality and variability in study designs.

The review highlighted a lack of clarity on the optimal stimulation parameters for TENS and emphasized the need for larger, well-designed multi-centre trials to better assess the long-term effectiveness of TENS in managing chronic pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. Carroll, D., Moore, RA., McQuay, HJ., et al.[2018]

In a pilot study involving 20 patients with cancer pain, transcutaneous electrical nerve stimulation (TENS) was found to be safe, with 85% of patients using intensity-modulated TENS (IMT) reporting at least slight pain improvement compared to 50% with placebo TENS (PBT).

However, the overall change in average pain intensity did not significantly differ between IMT and PBT, suggesting that while TENS may be desired by patients, it may not provide greater analgesic effects than placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for advanced cancer pain inpatients in specialist palliative care-a blinded, randomized, sham-controlled pilot cross-over trial. Siemens, W., Boehlke, C., Bennett, MI., et al.[2021]

Transcutaneous electrical nerve stimulation (TENS) is a non-invasive and effective method for pain relief, particularly in obstetrics and gynecology, where it has been shown to alleviate labor pain and treat primary dysmenorrhea.

Despite the development of new TENS devices that meet clinical requirements, their use remains limited, suggesting a need for greater awareness and encouragement among patients and healthcare providers to utilize this efficient pain management option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) as a pain-relief device in obstetrics and gynecology. Kaplan, B., Rabinerson, D., Pardo, J., et al.[2020]

High-frequency transcutaneous electrical nerve stimulation (hfTENS) significantly reduced maximum pain scores during medication abortion, with median scores of 7.0 for hfTENS users compared to 10.0 for those receiving a sham treatment, indicating its efficacy as a pain management option.

Patients using hfTENS also reported a significant reduction in pain immediately after treatment, suggesting that hfTENS can be an effective nonpharmacologic alternative for managing pain during medication abortion.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation to Reduce Pain With Medication Abortion: A Randomized Controlled Trial. Goldman, AR., Porsch, L., Hintermeister, A., et al.[2021]

Transcutaneous electrical nerve stimulation (TENS) is effective for pain relief during labor and has been shown to be safe for both mothers and babies, with no evidence of harm.

TENS not only helps inhibit pain signals but may also enhance the body's natural pain relief mechanisms, making it a popular choice among women for managing labor pain, especially in short labors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Analgesia in labour: a review of the TENS method. Cluett, E.[2004]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain intensity during or immediately after treatment compared to placebo, based on a systematic review of 381 randomized controlled trials involving over 24,500 participants.

TENS also shows lower pain intensity compared to standard pharmacological and non-pharmacological treatments, with moderate-certainty evidence indicating it is effective and generally safe, as adverse events were mild and similar to those of comparators.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and safety of transcutaneous electrical nerve stimulation (TENS) for acute and chronic pain in adults: a systematic review and meta-analysis of 381 studies (the meta-TENS study). Johnson, MI., Paley, CA., Jones, G., et al.[2022]

High-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) was found to be a noninferior alternative to intravenous (IV) sedation for managing pain during first-trimester aspiration abortion, based on a study involving 109 participants.

The study demonstrated that TENS could provide effective pain relief, making it a valuable option for patients who may not have access to IV sedation due to various restrictions, thus improving overall access to abortion care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Lerma, K., Goldthwaite, LM., Blumenthal, PD., et al.[2021]

In a study of 52 patients who underwent total abdominal hysterectomy with bilateral salpingo-oophorectomy, TENS significantly improved quality of recovery (QoR) scores compared to a sham treatment group.

Patients receiving TENS reported significantly lower dynamic pain scores during coughing, indicating that TENS may effectively manage certain types of postoperative pain, although it did not affect static pain scores or total analgesic consumption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of transcutaneous electrical nerve stimulation on quality of recovery and pain after abdominal hysterectomy. Karaman, S., Karaman, T., Deveci, H., et al.[2022]

In a study of 65 postoperative patients who used transcutaneous electrical nerve stimulation (TENS) after foot surgery, there was a significant reduction in the need for oral analgesics, with an overall decrease of 74.9% in analgesic medication usage.

The use of TENS also led to a lesser reduction in intramuscular analgesics, suggesting that TENS can effectively manage postoperative pain and reduce reliance on traditional pain medications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pain reduction with transcutaneous electrical nerve stimulation after foot surgery. Cornell, PE., Lopez, AL., Malofsky, H.[2009]

In a study of 31 cardiac surgery patients, those using functioning TENS units required significantly less morphine and showed improved pulmonary function (PEFR and FVC) on the second postoperative day compared to those with non-functioning units.

The findings suggest that TENS may effectively aid in postoperative pain relief, particularly in the early recovery phase, although some patients experienced a placebo effect with non-functioning units.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the transcutaneous electrical nerve stimulator for postoperative analgesia following cardiac surgery. Navarathnam, RG., Wang, IY., Thomas, D., et al.[2022]

A scoping review of 263 studies identified 6 relevant articles that evaluated the effectiveness of transcutaneous nerve electrostimulation (TENS) therapy for pain relief during labor, using the visual analogue scale (VAS) for measurement.

The results suggest that TENS is a promising nonpharmacological option for reducing pain during delivery, indicating its potential as a safe alternative to medication for labor pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Nerve Electrostimulation (TENS) in Pain Relief During Labor: A Scope Review. Reis, CCSD., Dias, LDC., Carvalho, LB., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/33278292/

Transcutaneous Electrical Nerve Stimulation to Reduce ... High-frequency TENS reduced maximum pain scores within 8 hours of misoprostol and reduced pain scores immediately after treatment compared with placebo.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03187002

Transcutaneous Electrical Nerve Stimulation (TENS) for ... The investigators propose a randomized controlled trial comparing TENS to IV sedation (in conjunction with local anesthesia) among women presenting for first- ...

3. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782425001465

A blinded randomized controlled trial In a blinded randomized trial, the median pain scores during first-trimester procedure abortion did not differ between those receiving TENS or sham. However, ...

4. contraceptionjournal.org contraceptionjournal.org/article/S0010-7824(24)00312-3/pdf

A BLINDED RANDOM Objectives: We aimed to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) to manage pain during first-tri- mester procedural abortion ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34352845/

Transcutaneous Electrical Nerve Stimulation for Pain ... We found TENS to be a noninferior alternative to IV sedation for aspiration pain during first-trimester abortion.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03925129

Transcutaneous Electrical Nerve Stimulation (TENS) for ... Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Management With Medication Abortion Through 70 Days' Gestation. ClinicalTrials.gov ID NCT03925129.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782424003123

p038 - transcutaneous electrical nerve stimulation (tens) for ... We aimed to evaluate the efficacy of transcutaneous electrical nerve stimulation (TENS) to manage pain during first-trimester procedural abortion for those not ...

8. withpower.com withpower.com/trial/phase-abortion-in-second-trimester-7-2024-8e07d

TENS Unit for Pain After Abortion This N/A medical study run by Queen's Medical Center is evaluating whether TENS Unit will have tolerable side effects & efficacy for patients with Abortion.