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

Trial Summary

What is the purpose of this trial?

Low back pain is a significant public health problem, is very prevalent, and is often characterized by the persistence of symptoms. Unfortunately, substantial improvements in people with chronic low back pain are rare, causing most people to live with the pain. People with chronic low back pain may have an exaggerated pain response to nociceptive input into tissues that may also cause symptoms distant from the site of the primary symptoms. Historically, these symptoms were thought to be related to pathoanatomic changes to the muscles, ligaments, or joints. However, the severity of these structural changes weakly correlates with the clinical presentation and, in most cases, is not directly related to diagnostic image findings. Patients with chronic musculoskeletal pain, in general, show signs of local/central sensitization. The central sensitization may appear to be directly correlated with the intensity and duration of pain. Therefore, it is essential to reduce pain intensity and minimize the duration of pain to prevent this from happening. Pain relief for chronic low back pain patients should be aimed at treatments that reduce central excitability and increase central inhibition. Research into chronic low back pain treatment has demonstrated strong evidence that different types of exercise decrease pain and improve quality of life. However, exercise itself may be painful, preventing a person from exercising. Thus, treatments aimed at decreasing pain will improve a person's ability to exercise and participate in activities of daily living. One treatment aimed at reducing central excitability and increasing central inhibition is transcutaneous electrical nerve stimulation (TENS). TENS is a "non-pharmacological" treatment for pain that is inexpensive, safe, and easy to use. Prior studies show that TENS utilizes opioid receptors both spinally and supraspinally to inhibit nociceptive dorsal horn neurons, reduce excitatory neurotransmitter release, and reduce hyperalgesia. Thus, TENS may be particularly useful in people with chronic low back pain because it can activate descending inhibitory pathways (reduced in chronic low back pain patients) and inhibit central excitability (increased in chronic low back pain patients). Previous studies that have investigated the effects of TENS on pain in low back pain patients have failed to use proper intensities of current, and the assessment of pain was not performed during the peak of the analgesic response. Previous studies show inadequate intensities do not reduce pain or increase pressure pain thresholds. Further, TENS typically does not affect resting pain, while changes in pressure pain thresholds and pain with movement are reduced. Thus, the current study proposes to assess the effects of TENS on measures of pain, function, and descending inhibition using the maximal tolerable intensity of TENS applied to a large area of the trunk.

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 data supports the effectiveness of the treatment TENS for chronic lower back pain?

The effectiveness of TENS for chronic lower back pain is still debated, as studies show mixed results and highlight issues with study methods. However, some users report benefits, such as improved sleep, when using TENS for chronic pain. ^{1 2 3 4 5}

Is TENS safe for humans?

TENS has been used for over 30 years in various clinical settings to treat different pain conditions, and it is generally considered a safe alternative to medications with more side effects. ^{2 3 6 7 8}

How is the treatment TENS unique for chronic lower back pain?

TENS (Transcutaneous Electrical Nerve Stimulation) is unique because it is a non-drug treatment that uses low voltage electrical currents applied to the skin to help manage pain. Unlike medications, it doesn't involve taking pills and is based on the gate-control theory of pain, which suggests it can block pain signals from reaching the brain. ^{3 7 8 9 10}

Research Team

Richard E Liebano, PhD

Principal Investigator

University of Hartford

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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 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 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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic low-back pain. [2022]

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

Efficacy of the transcutaneous electrical nerve stimulation for the treatment of chronic low back pain: a meta-analysis. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) versus placebo for chronic low-back pain. [2022]

4. United States 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. [2022]

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

Impact of transcutaneous electrical nerve stimulation on sleep in chronic low back pain: a real-world retrospective cohort study. [2022]

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

A Meta-Analysis of Transcutaneous Electrical Nerve Stimulation for Chronic Low Back Pain. [2022]

7. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation (TENS) for chronic pain. [2018]

8. Netherlands 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. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation and acupuncture-like transcutaneous electrical nerve stimulation for chronic low back pain. [2018]

10. England pubmed.ncbi.nlm.nih.gov

Transcutaneous electrical nerve stimulation for acute pain. [2022]