TENS Therapy for Fibromyalgia

(TENSXFibro Trial)

Overseen By Guillaume Léonard

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Disqualifiers: Physically active, Cardiovascular diseases, others

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

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether TENS (a type of nerve stimulation) can reduce pain for women with fibromyalgia during and after exercise. Researchers aim to determine if TENS is more effective than a placebo (a sham version of TENS) in easing pain after resistance training. Participants must have fibromyalgia, be over 40, and experience ongoing pain in the lower back or legs. Those who are already very active or have certain health issues might not qualify. As an unphased trial, this study offers participants the chance to contribute to valuable research that could enhance pain management strategies for fibromyalgia.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you must avoid caffeine and painkillers 6 hours before the experiment.

What prior data suggests that TENS therapy is safe for women with fibromyalgia?

Research has shown that TENS therapy is generally safe for managing pain. Studies have found that TENS can reduce pain levels without causing serious side effects. For instance, one study reported a decrease in pain during or immediately after using TENS, with no major negative effects.

Another study described TENS as affordable and safe, suggesting it could improve mobility by reducing pain. So far, TENS appears well-tolerated, making it a promising option for those with long-term pain conditions, such as fibromyalgia. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the usual treatments for fibromyalgia, which often include medications like antidepressants and pain relievers, TENS (Transcutaneous Electrical Nerve Stimulation) therapy offers a non-drug approach. This therapy stands out because it uses electrical impulses to relieve pain directly at the source, providing immediate relief without the side effects associated with medications. Researchers are excited about this trial because it could offer a safer, drug-free alternative for managing fibromyalgia pain, potentially enhancing the quality of life for patients who struggle with chronic discomfort. Additionally, the inclusion of resistance exercise alongside TENS may further improve outcomes by addressing both pain and physical strength.

What evidence suggests that TENS therapy is effective for fibromyalgia?

Research has shown that TENS, or Transcutaneous Electrical Nerve Stimulation, can reduce pain for people with fibromyalgia. One study found that TENS provided significant pain relief for fibromyalgia patients. Another study showed that just one session of TENS lessened pain and tiredness. TENS has also eased pain in other conditions, such as long-COVID and general pain. In this trial, participants will receive either Conventional TENS with Resistance Exercise or Sham TENS with Resistance Exercise to evaluate its effectiveness in relieving exercise-induced pain in people with fibromyalgia. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for postmenopausal women with fibromyalgia who experience pain during exercise. Participants will be involved in a resistance training session and receive either real or sham TENS therapy to manage their pain.

Inclusion Criteria

I am 50 years old or older.

I can avoid caffeine, painkillers for 6 hours, and not smoke for 2 hours before the test.

I have gone through menopause.

Exclusion Criteria

Have already participated in a research project involving TENS or used a TENS device in the past.

Have one or more contraindications to physical activity

Are physically active prior to the start of the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo a supervised resistance training session and receive either conventional TENS or Sham TENS treatment during and after exercise

1 day

1 visit (in-person)

Follow-up

Participants complete pain assessments, measuring both intensity and unpleasantness, up to 24 hours after exercise sessions

1 day

What Are the Treatments Tested in This Trial?

Interventions

• TENS Therapy

Trial Overview The study tests if conventional TENS can reduce the intensity and unpleasantness of pain more effectively than Sham TENS during and after resistance training in postmenopausal women with fibromyalgia.

How Is the Trial Designed?

Group I: Conventional TENS with Resistance Exercise Experimental Treatment 1 Intervention

Conventional TENS will be administered using a 2-channel TENS unit (Biomed 2000XL) and carbon electrodes. Electrodes will be placed on the area identified by the participant as most painful (loco dolenti). The TENS parameters will be set to conventional stimulation (100 Hz, 60 ms), with the intensity adjusted to produce a strong paresthesia sensation without causing pain. TENS will be applied for 10 minutes before the first set and maintained throughout the exercise sets.

Group II: Sham TENS with Resistance Exercise Placebo Group 1 Intervention

The sham TENS procedure will mimic the conventional TENS procedure, but the modified TENS device will not deliver electrical stimulation. Participants will be blinded to the intervention they will receive and will be told they could receive 2 types of TENS.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38511391/

Effectiveness of transcutaneous electrical nerve stimulation ... This meta-analysis, including the largest number of studies, showed that TENS intervention is an effective therapy to reduce pain and disability and increase ...

2. nature.com nature.com/articles/s41598-024-78651-5

a pilot randomized clinical trial | Scientific Reports Daily TENS therapy showed potential in reducing functional interference from pain, fatigue, and gait alterations in long-COVID individuals. The ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1526590023006533

Influence of Transcutaneous Electrical Nerve Stimulation ... Clinically relevant reductions in clinical pain, perceived fatigue, and MEP occur following a single session of TENS and 4 weeks of routine TENS use in FM.29, ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6485914/

Transcutaneous electrical nerve stimulation (TENS) for ... One study found 10/28 participants reported pain relief of 25% or greater with TENS compared with 10/24 participants using superficial warmth (42 °C). We judged ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT00932360

Transcutaneous Electrical Nerve Stimulation (TENS) and ... The primary aim of the study is to test the effectiveness of TENS on pain and central excitability in a crossover design study for patients with Fibromyalgia ...

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

What is the effectiveness and adverse event data ... What is the effectiveness and adverse event data of transcutaneous electrical nerve stimulation (TENS) in reducing pain in adults with chronic pain? An overview ...

7. 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.