TENS for Chronic Lower Back Pain

(TENS and LBP Trial)

Overseen By Richard Liebano

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Hartford

Must not be taking: Opioids

Disqualifiers: Serious spinal disorders, Neurological diseases, Severe cardiorespiratory disease, Pregnancy, Cancer, others

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 3 weeks

34 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how TENS (Transcutaneous Electrical Nerve Stimulation) can assist individuals with chronic lower back pain lasting at least three months. TENS, a non-drug treatment, sends mild electrical pulses to the nerves to reduce pain. The trial aims to determine if using TENS at its strongest comfortable level can alleviate pain and improve daily life for those with ongoing back issues. Individuals experiencing significant back pain who have not used TENS in the last five years may be suitable candidates for this study. As an unphased study, this trial provides a unique opportunity to investigate a non-drug treatment option that could enhance quality of life.

Will I have to stop taking my current medications?

The trial requires that you do not use opioids, but it does not specify if you need to stop other medications. It's best to discuss your current medications with the trial team.

What prior data suggests that TENS is safe for treating chronic lower back pain?

Research shows that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe. Studies have found that TENS reduces pain without causing serious side effects. This therapy uses a gentle electrical current to ease pain and is both affordable and easy to use. Evidence suggests that TENS effectively lowers pain during or immediately after use, without significant problems. This makes it a well-tolerated option for those with chronic pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Transcutaneous Electrical Nerve Stimulation (TENS) for chronic lower back pain because it offers a non-invasive alternative to standard treatments like medications and physical therapy. Unlike drugs that can cause side effects or require long-term use, TENS uses electrical impulses to potentially relieve pain quickly and safely. This method directly targets the nerves responsible for pain, which might lead to faster relief without the need for medication. Additionally, TENS can be easily used at home, giving patients more control over their pain management.

What evidence suggests that TENS is effective for chronic lower back pain?

This trial will compare different methods of using transcutaneous electrical nerve stimulation (TENS) for chronic lower back pain. Research has shown that TENS hasn't consistently relieved long-term low back pain. Some studies found TENS no more effective than placebo treatments. TENS uses electrical currents to stimulate nerves and reduce pain, but past research often employed settings too low to be effective. The theory is that TENS might help by blocking pain signals in the body. However, current evidence does not strongly support TENS for long-term low back pain. ^{5 6 7 8 9}

Who Is on the Research Team?

Richard E Liebano, PhD

Principal Investigator

University of Hartford

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who have been experiencing lower back pain for at least three months, with a pain level of at least 3 out of 10. Participants should not have used TENS therapy in the past five years.

Inclusion Criteria

I have had back pain for at least 3 months.

My pain level is at least a 3 out of 10.

I have never used TENS or it's been 5 years since I last used it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive active TENS, placebo TENS, or no treatment control in a randomized crossover design

3 weeks

Multiple visits for each treatment phase

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Transcutaneous Electrical Nerve Stimulation (TENS)

Trial Overview

The study tests if Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain and improve function in people with chronic low back pain by using high-intensity currents on a large area of the trunk to potentially decrease central nervous system excitability.

How Is the Trial Designed?

Group I: Active TENS Experimental Treatment 1 Intervention

Active TENS: 100 Hz, 200 μs at maximal tolerable intensity

Group II: No TENS Active Control 1 Intervention

Participants will wear a TENS unit that will be turned off to blind the outcome assessor

Group III: Placebo TENS Placebo Group 1 Intervention

Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off.

Transcutaneous Electrical Nerve Stimulation (TENS) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in European Union as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Approved in Canada as TENS for:

• Chronic pain
• Acute pain
• Postoperative pain
• Low back pain
• Osteoarthritis pain
• Diabetic peripheral neuropathy
• Fibromyalgia
• Neuropathic pain

Who Is Running the Clinical Trial?

University of Hartford

Lead Sponsor

Trials

15

Recruited

600+

Published Research Related to This Trial

A systematic review of two randomized controlled trials involving 175 patients found inconsistent evidence regarding the effectiveness of transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain, with one trial showing significant pain relief compared to placebo and the other showing no significant differences.

The authors concluded that more extensive and well-designed studies are necessary to accurately evaluate TENS's effectiveness and to consider the long-term risks and benefits of its use in managing chronic low-back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. Khadilkar, A., Milne, S., Brosseau, L., et al.[2022]

In a study of 554 chronic low back pain (CLBP) patients using transcutaneous electrical nerve stimulation (TENS) over 10 weeks, those who reported improvement in pain interference with sleep experienced an increase in total sleep time by 29 minutes compared to those who did not improve.

The improved group also showed a lower periodic leg movement index, suggesting that TENS not only helps with pain but may also enhance sleep quality, highlighting the importance of sleep as an outcome measure in TENS effectiveness for CLBP.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. Gozani, SN., Ferree, TC., Moynihan, M., et al.[2022]

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]

Patients using transcutaneous electrical nerve stimulation (TENS) for chronic musculoskeletal pain reported benefits beyond just pain relief, including reduced muscle tension and improved psychological well-being.

The study suggests that evaluating TENS solely on pain scales may miss important outcomes, indicating that TENS should be viewed as a complex intervention with multiple direct and indirect benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Direct and Indirect Benefits Reported by Users of Transcutaneous Electrical Nerve Stimulation for Chronic Musculoskeletal Pain: Qualitative Exploration Using Patient Interviews. Gladwell, PW., Badlan, K., Cramp, F., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) and acupuncture-like TENS (ALTENS) show potential in reducing pain and improving range of motion in patients with chronic low back pain, based on a review of six trials involving 288 participants.

The odds of experiencing pain improvement were significantly higher with ALTENS compared to placebo, with an odds ratio of 7.22, while TENS also showed a positive effect, indicating both methods may be beneficial for short-term pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation and acupuncture-like transcutaneous electrical nerve stimulation for chronic low back pain. Gadsby, JG., Flowerdew, MW.[2018]

A systematic review included 12 randomized controlled trials with 919 participants to evaluate the effectiveness of Transcutaneous Electrical Nerve Stimulation (TENS) for treating acute pain, but insufficient data prevented definitive conclusions.

The review highlighted that many studies were excluded because TENS was used alongside other treatments, indicating a need for more focused research on TENS as a standalone therapy for acute pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. Walsh, DM., Howe, TE., Johnson, MI., et al.[2022]

Transcutaneous electrical nerve stimulation (TENS) significantly reduces pain in patients with chronic low back pain, with a standardized mean difference of 0.844 indicating substantial improvement based on a meta-analysis of 13 studies involving 267 patients.

TENS treatment for less than 5 weeks showed significant pain relief, while longer treatments did not yield the same level of effectiveness, suggesting optimal treatment duration for pain management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. Jauregui, JJ., Cherian, JJ., Gwam, CU., et al.[2022]

A review of four high-quality randomized controlled trials involving 585 patients found conflicting evidence on the effectiveness of TENS for reducing chronic low-back pain intensity, with no significant improvement in back-specific functional status.

Overall, the evidence does not support the routine use of TENS for chronic low-back pain management, as it showed minimal benefits compared to placebo, and further research is needed to clarify its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. Khadilkar, A., Odebiyi, DO., Brosseau, L., et al.[2022]

In a double-blind trial with 62 participants suffering from chronic low back pain, TENS significantly reduced pain intensity compared to sham-TENS, with effects lasting up to 24 hours after treatment.

Despite the pain relief observed, there were no significant changes in plasma levels of beta-endorphin or met-enkephalin, suggesting that the mechanism of action for TENS may not involve these specific pain-relief hormones.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation effects on pain-intensity and endogenous opioids levels among chronic low-back pain patients: A randomised controlled trial. Ezema, CI., Onyeso, OK., Nna, EO., et al.[2022]

A meta-analysis of five trials involving 421 subjects found no significant difference in efficacy between active transcutaneous electrical nerve stimulation (TENS) and placebo TENS for treating chronic low back pain.

The study highlights the need for better-designed trials with standardized outcome measures, as current evidence does not support the use of TENS as an effective treatment for chronic low back pain.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis. Brosseau, L., Milne, S., Robinson, V., et al.[2022]

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/11406059/

Transcutaneous electrical nerve stimulation (TENS) for ...

Reviewer's conclusions: The results of the meta-analysis present no evidence to support the use of TENS in the treatment of chronic low back pain.

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/11884907/

Efficacy of the transcutaneous electrical nerve stimulation ...

Conclusion: The results of the meta-analysis present no evidence to support the use or nonuse of TENS alone in the treatment of chronic low back pain.

3.

trialsjournal.biomedcentral.com

trialsjournal.biomedcentral.com/articles/10.1186/s13063-024-08089-7

Effects of transcutaneous electrical nerve stimulation on pain ...

This study will provide evidence concerning the effects and mechanisms of TENS treatment in participants with chronic non-specific low back pain ...

4.

clinicaltrials.gov

clinicaltrials.gov/show/NCT05812885

Transcutaneous Electrical Nerve Stimulation (TENS) and ...

Research into chronic low back pain treatment has demonstrated strong evidence that different types of exercise decrease pain and improve quality of life.

5.

nejm.org

nejm.org/doi/full/10.1056/NEJM199006073222303

A Controlled Trial of Transcutaneous Electrical Nerve ...

We conclude that for patients with chronic low back pain, treatment with TENS is no more effective than treatment with a placebo, and TENS adds no apparent ...

6.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/35144946/

Efficacy and safety of transcutaneous electrical nerve ...

There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7401682/

What is the effectiveness and adverse event data ...

For policy makers and funders: There is no evidence to either support or disprove the use of TENS in chronic pain due to methodological limitations of studies.

8.

my.clevelandclinic.org

my.clevelandclinic.org/health/treatments/15840-transcutaneous-electrical-nerve-stimulation-tens

Transcutaneous Electrical Nerve Stimulation (TENS)

A TENS unit uses a mild electrical current to reduce pain. Providers use this therapy to treat conditions like osteoarthritis, tendinitis and fibromyalgia.

9.

bmjopen.bmj.com

bmjopen.bmj.com/content/12/2/e051073

Efficacy and safety of transcutaneous electrical nerve ...

There was moderate-certainty evidence that pain intensity is lower during or immediately after TENS compared with placebo and without serious adverse events.