Electrical Stimulation for Pain and Depression in Liver Cirrhosis

(RESTORE Trial)

Overseen By Melanie Herschel

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Dementia, Cognitive impairment, Liver transplant, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

30 Participants Needed

Trial Summary

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. Please consult with the study team for guidance.

What data supports the effectiveness of the treatment Sham Transcutaneous Electrical Acustimulation (TEA), Transcutaneous Electrical Acustimulation (TEA) for pain and depression in liver cirrhosis?

Research shows that Transcutaneous Electrical Acupoint Stimulation (TEAS), similar to TEA, has been effective in reducing pain in various conditions, including postoperative pain and cancer-related pain. This suggests that TEA might also help with pain management in liver cirrhosis. ^{1 2 3 4 5}

Is transcutaneous electrical acupoint stimulation (TEAS) safe for humans?

Research on transcutaneous electrical acupoint stimulation (TEAS) for various conditions, like pain management and drug detoxification, suggests it is generally safe for humans. Studies have used TEAS in different settings without significant safety concerns, indicating it is a low-risk treatment option. ^{2 3 6 7 8}

How does the treatment Transcutaneous Electrical Acustimulation (TEA) differ from other treatments for pain and depression in liver cirrhosis?

Transcutaneous Electrical Acustimulation (TEA) is unique because it uses a mild electric current applied to specific acupoints on the skin, avoiding the use of needles. This non-invasive approach is different from traditional drug treatments and may offer an alternative for managing pain and depression without the side effects associated with medications. ^{1 2 3 5 8}

What is the purpose of this trial?

This study is being done to better understand how the study team can treat pain for people with cirrhosis and depression. Enrolled participants on this feasibility study will be randomized to Transcutaneous Electrical Acustimulation (TEA) or sham TEA.

Research Team

Elliot Tapper, MD

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for English-speaking adults with cirrhosis who suffer from chronic pain and, in some cases, depression. Participants must rate their pain at 4 or higher on a scale of 0-10 for most days over the past three months. They should be willing to use an electrical stimulation device but not expecting a liver transplant within the next six months.

Inclusion Criteria

I have chronic pain rated 4 or higher for most days in the past 3 months.

Depression (in at least half of participants) - must meet the criteria as outlined in the protocol

English speaking

Exclusion Criteria

Deemed unsuitable by the study investigator

Unable or unwilling to provide consent

No email address

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Run-in Period

Participants undergo a two-week run-in period before starting treatment

2 weeks

Treatment

Participants receive either Transcutaneous Electrical Acustimulation (TEA) or sham TEA for 8 weeks

8 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

Treatment Details

Interventions

• Sham Transcutaneous Electrical Acustimulation (TEA)
• Transcutaneous Electrical Acustimulation (TEA)

Trial Overview The study compares Transcutaneous Electrical Acustimulation (TEA), which delivers electrical pulses to relieve pain and treat depression, against sham TEA—a placebo version without active stimulation—to determine its effectiveness in patients with cirrhosis.

Participant Groups

Group I: Transcutaneous Electrical Acustimulation (TEA) Experimental Treatment 1 Intervention

Participants will have a two-week run-in period and then 8 weeks of treatment.

Group II: TEA Sham Placebo Group 1 Intervention

Participants will have a two-week run-in period and then 8 weeks of sham treatment.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

This clinical trial will evaluate the effectiveness of transcutaneous electrical acupoint stimulation (TEAS) combined with opioids in managing moderate to severe cancer-related pain in 104 patients with hepatocellular carcinoma (HCC).

The study aims to assess pain relief and quality of life improvements using various measures, including the Numerical Rating Scale (NRS) and the Brief Pain Inventory (BPI), over a treatment period of one week.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acupoint Stimulation for Moderate to Severe Pain in Hepatocellular Carcinoma: A Protocol for a Randomized Controlled Trial. Wu, P., Zhu, L., Zheng, SY., et al.[2022]

This multicenter trial will evaluate the efficacy of transcutaneous electrical acupoint stimulation (TEAS) combined with opioid drugs in treating moderate to severe cancer-related pain in 160 patients over a three-week period, aiming to improve pain management and reduce opioid side effects.

The study will assess primary outcomes through changes in pain scores and morphine dosage, while also examining the potential benefits of TEAS on immune function and overall quality of life, addressing a significant gap in current cancer pain management research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial. Liang, Y., Bao, G., Gong, L., et al.[2020]

In a pilot study involving 48 inpatients undergoing opioid detoxification, those receiving active transcutaneous electric acupoint stimulation (TEAS) showed significantly lower rates of drug use (35% vs. 77%) compared to those receiving sham treatment by two weeks post-discharge.

Participants in the active TEAS group also reported greater improvements in pain interference and physical health, suggesting that TEAS is a feasible and effective adjunctive treatment for enhancing recovery during opioid detoxification.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. Meade, CS., Lukas, SE., McDonald, LJ., et al.[2022]

In a study involving 23 patients with chronic pancreatitis, neither electroacupuncture nor transcutaneous electric nerve stimulation (TENS) provided significant pain relief compared to sham treatments.

The findings suggest that these alternative therapies do not effectively replace or enhance standard medical treatments for managing pain in pancreatitis patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acupuncture and transcutaneous electric nerve stimulation in the treatment of pain associated with chronic pancreatitis. A randomized study. Ballegaard, S., Christophersen, SJ., Dawids, SG., et al.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Analgesic effect of transcutaneous electrical nerve stimulation after laparoscopic cholecystectomy. [2016]

2. England pubmed.ncbi.nlm.nih.gov

Effects of transcutaneous electric acupoint stimulation on drug use and responses to cue-induced craving: a pilot study. [2021]

3. New Zealand pubmed.ncbi.nlm.nih.gov

Transcutaneous Electrical Acupoint Stimulation for Moderate to Severe Pain in Hepatocellular Carcinoma: A Protocol for a Randomized Controlled Trial. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Perioperative Transcutaneous Electrical Acupoint Stimulation for Postoperative Pain Relief Following Laparoscopic Surgery: A Randomized Controlled Trial. [2018]

5. England pubmed.ncbi.nlm.nih.gov

Evaluating the analgesic effect and advantage of transcutaneous electrical acupoint stimulation combined with opioid drugs for moderate to severe cancer-related pain: a study protocol for a randomized controlled trial. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

A randomized trial of transcutaneous electric acupoint stimulation as adjunctive treatment for opioid detoxification. [2022]

7. New Zealand pubmed.ncbi.nlm.nih.gov

Effects of Transcutaneous Electrical Acupoint Stimulation (TEAS) on Postoperative Recovery in Patients with Gastric Cancer: A Randomized Controlled Trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Acupuncture and transcutaneous electric nerve stimulation in the treatment of pain associated with chronic pancreatitis. A randomized study. [2019]