Chronic Low-back PainTENS and LBPNCT05812885
Transcutaneous Electrical Nerve Stimulation (TENS) and Low Back Pain
A study testing TENS in people with Chronic Low-back Pain, run by University of Hartford at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Low-back Pain
- What is being tested?
- TENS
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Nov 2023to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- people who have experienced back pain for at least 3 months
- and have reported a minimal pain level of 3 on the 0-10 Pain Numerical Rating Scale (NRS)
- age from 18-60
- TENS naive or have not used TENS for 5 years.
- Both men and women may participate in the study
Who cannot join
- Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- nerve root disorders confirmed by neurological tests;
- neurological diseases
- severe cardiorespiratory disease
- pregnancy
- skin infection or lesions or change in sensation at the TENS application site
Show all 10Show fewer
- cancer
- cardiac pacemaker
- allergy to electrodes
- use of opioids.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Hartford
West Hartford, Connecticut, 06117
Richard Liebano
About this study
Official title: Transcutaneous Electrical Nerve Stimulation (TENS) and Chronic Low-Back Pain: A Randomized Crossover 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.
Read more
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.
Read the detailed description
The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Each subject will receive all 3 interventions in random order.
The following tools will be used to measure pain (Numeric Rating Scale), central excitability (pressure pain thresholds, temporal summation and CPM) and function (sit-to-stand test and repeated trunk flexion).
- Conditions
- Chronic Low-back Pain
- Being tested
- TENS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Active TENS
| Study group | Role | What they receive |
|---|---|---|
| Active TENS | Experimental | Active TENS: 100 Hz, 200 μs at maximal tolerable intensity Receives: Device: TENS |
| Placebo TENS | Placebo comparator | Placebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off. Receives: Device: TENS |
| No TENS | No intervention | Participants will wear a TENS unit that will be turned off to blind the outcome assessor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain at Rest
Pain at Rest Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
Measured: 3 weeks
Pain With Movement
Pain With Movement Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
Measured: 3 weeks
Secondary outcomes (6)
Sit-to-Stand Test
Five sit-to-stand repetitions will be completed in two trials with an average of two trials for scoring
Measured: 3 weeks
Repeated trunk flexion
From a neutral standing position, the subject will be required to flex to the limit of the range and return to the upright position as fast as tolerable.This activity will be repeated 10 times, and the total procedure will be timed with a stopwatch
Measured: 3 weeks
Pressure Pain Threshold (PPT)
A digital pressure algometer will measure the pain threshold to deep mechanical stimuli.
Measured: 3 weeks
Heat Pain Threshold (HPT)
Superficial heat pain sensitivity will be assessed using a handheld thermode.
Measured: 3 weeks
Temporal Summation
Temporal summation will be induced by a pressure algometer
Measured: 3 weeks
Conditioned pain modulation
A cold pressor test will be used to assess the activation of the conditioned pain modulation.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start15 Nov 2023
- Primary completionMay 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Low-back PainStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Crossover Assignment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Hartford
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard Liebano, University of Hartford
- Investigators
- Richard E Liebano, PhD, Principal investigator, University of Hartford
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05812885
- Sponsor's protocol ID
- 23-03-187
- Acronym
- TENS and LBP
- Status last verified
- Dec 2024
- First submitted
- 31 Mar 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Liebano RE, Sluka KA, Roy J, Savinelli M, Dailey DL, Riley SP. Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial. Trials. 2024 Apr 6;25(1):242. doi: 10.1186/s13063-024-08089-7.
PubMed 38582874
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Transcutaneous Electrical Nerve Stimulation (TENS) and Chronic Low-Back Pain: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05812885
- Acronym / sponsor ID
- TENS and LBP / 23-03-187
- Conditions
- Chronic Low-back Pain
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of HartfordUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- May 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 14 Apr 2023 (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.
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.
Detailed description
The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Each subject will receive all 3 interventions in random order.
The following tools will be used to measure pain (Numeric Rating Scale), central excitability (pressure pain thresholds, temporal summation and CPM) and function (sit-to-stand test and repeated trunk flexion).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Crossover Assignment
| Arm | Type | Receives |
|---|---|---|
| Active TENS | Experimental | Device: TENSActive TENS: 100 Hz, 200 μs at maximal tolerable intensity |
| Placebo TENS | Placebo comparator | Device: TENSPlacebo TENS: 100 Hz, 200 μs on for 45 seconds and then ramps off. |
| No TENS | No intervention | –Participants will wear a TENS unit that will be turned off to blind the outcome assessor |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- people who have experienced back pain for at least 3 months
- and have reported a minimal pain level of 3 on the 0-10 Pain Numerical Rating Scale (NRS)
- age from 18-60
- TENS naive or have not used TENS for 5 years.
- Both men and women may participate in the study
Key exclusion criteria (10 listed)
- Serious spinal disorders, such as fractures, tumors, or inflammatory arthritis disease
- nerve root disorders confirmed by neurological tests;
- neurological diseases
- severe cardiorespiratory disease
- pregnancy
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 |
|---|---|---|
| TENSActive TENS | Device | Active TENS, Placebo TENS |
Primary outcome
Pain at Rest
Time frame: 3 weeks
Pain at Rest Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
Pain With Movement
Time frame: 3 weeks
Pain With Movement Difference Score Pre-intervention and Post Intervention measured by the Numeric Pain Rating Scale. It starts with the absence of pain (0) and reaches the worst pain imaginable (10).
6 secondary outcomes
Sit-to-Stand Test
Time frame: 3 weeks
Repeated trunk flexion
Time frame: 3 weeks
Pressure Pain Threshold (PPT)
Time frame: 3 weeks
Heat Pain Threshold (HPT)
Time frame: 3 weeks
Temporal Summation
Time frame: 3 weeks
Conditioned pain modulation
Time frame: 3 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 38582874Liebano RE, Sluka KA, Roy J, Savinelli M, Dailey DL, Riley SP. Effects of transcutaneous electrical nerve stimulation on pain, function, and descending inhibition in people with non-specific chronic low-back pain: a study protocol for a randomized crossover trial. Trials. 2024 Apr 6;25(1):242. doi: 10.1186/s13063-024-08089-7.
- 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.
Richard E Liebano, PhD principal investigator
University of Hartford
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TENS in people with Chronic Low-back Pain, run by University of Hartford 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 10 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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. Some participants in this study may receive a placebo. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Richard E Liebano, PhD (860.768.5181, liebano@hartford.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain at Rest (time frame: 3 weeks). The study lists 2 primary outcomes in all. 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 NCT05812885, which also lists 1 linked publication.
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 4 Dec 2024.