TENS + Physical Therapy for Fibromyalgia

(FM-TIPS Trial)

No longer recruiting at 6 trial locations

Overseen By Michele Costigan, RN

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Kathleen Sluka

Disqualifiers: Pacemaker, Epilepsy, Pregnancy, Cancer, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding Transcutaneous Electrical Nerve Stimulation (TENS) to regular physical therapy can ease pain from fibromyalgia, particularly during movement. Researchers seek to discover if this combination can also improve symptoms, enhance adherence to therapy, help participants achieve personal goals, and reduce medication use. Participants should have fibromyalgia, be referred for physical therapy, and be willing to use TENS. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants an opportunity to contribute to a potentially groundbreaking treatment.

Do I need to stop my current medications to join the trial?

The trial information does not specify if you need to stop your current medications. It aims to see if TENS can reduce medication use, but it doesn't say you must stop taking them.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) is generally safe. Studies have found that TENS can reduce pain during or immediately after use without causing serious side effects, potentially helping people move more comfortably. TENS is also considered safe for home use.

In past studies, TENS effectively addressed symptoms similar to fibromyalgia, suggesting it could help manage fibromyalgia symptoms when combined with physical therapy. Overall, TENS is well-tolerated, making it a promising option for those considering joining a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard care for fibromyalgia, which often involves medications like pain relievers and antidepressants, this treatment combines Transcutaneous Electrical Nerve Stimulation (TENS) with physical therapy. Researchers are excited about this approach because TENS offers a non-invasive way to potentially enhance pain relief by delivering electrical pulses to the nerves, which could be especially beneficial during physical activity. The unique aspect here is the integration of TENS with routine physical therapy, providing patients with an active role in managing their symptoms at home and during therapy sessions. This dual approach might offer a more comprehensive way to manage fibromyalgia symptoms compared to traditional methods.

What evidence suggests that TENS with PT could be effective for fibromyalgia?

Research has shown that Transcutaneous Electrical Nerve Stimulation (TENS) can reduce pain and improve the quality of life for people with fibromyalgia. One study found that TENS provided significant pain relief for some participants compared to other treatments. Another study demonstrated that daily TENS use helped reduce pain and tiredness in individuals with long-term conditions. Additionally, using TENS for four weeks led to noticeable reductions in pain and fatigue for fibromyalgia patients. In this trial, one group will receive TENS with physical therapy, which might help relieve fibromyalgia symptoms, while another group will receive physical therapy without TENS. ^{2 3 5 6 7}

Who Is on the Research Team?

Leslie Crofford, MD

Principal Investigator

Vanderbilt University

Dana Dailey, PhD, PT

Principal Investigator

University of Iowa

Kathleen Sluka, PhD, PT

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

This trial is for adults aged 18-99 with fibromyalgia or chronic neck/back pain who are referred for physical therapy. Participants must be fluent in English, able to consent, and willing to use TENS. It's not suitable for those with pacemakers, recent TENS use, unstable medical conditions, allergies to gel patches, cancer treatment, epilepsy or pregnancy.

Inclusion Criteria

Able to provide informed consent.

I have been diagnosed with fibromyalgia.

Fluent in reading English

Exclusion Criteria

You cannot use Transcutaneous Electrical Nerve Stimulation (TENS) if you have certain medical conditions that make it unsafe for you.

You have an implanted device like a pacemaker, defibrillator, or neurostimulator.

Currently pregnant or plan to become pregnant in the next 6 months

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Baseline and Initial Treatment

Participants receive TENS units and instructions during the second PT visit. Baseline assessments are completed at home before the next PT visit.

2 weeks

2 visits (in-person)

Treatment

Participants use TENS during PT sessions and at home. Assessments are conducted at 30, 60, 90, and 180 days.

6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• PT only
• Transcutaneous Electrical Nerve Stimulation (TENS) with PT

Trial Overview The study tests if adding Transcutaneous Electrical Nerve Stimulation (TENS) to regular physical therapy helps reduce movement-evoked pain in fibromyalgia patients more than just physical therapy alone. It also looks at whether TENS improves overall disease symptoms and reduces the need for medication.

How Is the Trial Designed?

Group I: No TENS with PT Experimental Treatment 1 Intervention

The No TENS group will receive usual PT care until the primary endpoint timeframe of 60 days. After completion of the research homework at 60 days, TENS units will be mailed to the participants and a study team member will complete virtual TENS instruction. The no TENS group will complete TENS to the end of the study at 6 months.

Group II: TENS with PT Active Control 1 Intervention

TENS with PT group: The TENS with PT group will receive usual PT care and following enrollment, during the second PT visit, participants will receive TENS units and instruction on use of the TENS units. TENS will be applied to the upper and lower back with butterfly electrodes using the following parameters: mixed frequency (2-125Hz), strong but comfortable intensity, variable pulse duration from 100-250 microseconds. TENS to be applied when the patient is active and doing exercises at home and during PT sessions for 30 minutes at least 2 hours per day. The TENS with PT group will complete TENS use to the end of the study at 6 months.

Who Is Running the Clinical Trial?

Kathleen Sluka

Lead Sponsor

Trials

3

Recruited

790+

Citations

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

Effectiveness of transcutaneous electrical nerve stimulation ... Effectiveness of transcutaneous electrical nerve stimulation improves pain intensity, disability and quality of life in patients with ...

2. 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 ...

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

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

4. 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, ...

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.