Adding TENS (transcutaneous electrical nerve stimulation) to outpatient physical therapy reduced pain and fatigue from movement in fibromyalgia patients, and the results lasted for at least six months, according to a new study led by researchers at the University of Iowa Health Care.
The study, led by Kathleen Sluka, PT, PhD, is the first real-world trial of TENS for fibromyalgia. The findings were published March 27 in the journal JAMA Network Openshow that TENS is a safe, effective, inexpensive, and readily available treatment for fibromyalgia, a chronic condition that causes pain, tenderness, and fatigue throughout the body.
It is one of the few treatments that specifically targets movement-induced pain and fatigue, which are significant barriers to participation in daily activities.”
Kathleen Sluka, PT, PhD, UI professor of Physical Therapy and Rehabilitation Science
TENS uses a small device with sticky electrodes to send mild electrical pulses through the skin to block or reduce pain. The study found that the pain-reducing effect of TENS was similar, if not better, than current FDA-approved medications for fibromyalgia.
“We were excited to see that patients also had less fatigue,” Sluka added. “Right now, there are no good treatments for fatigue. So the fact that we had anything that touched fatigue was pretty powerful.”
Fibromyalgia: complex, misunderstood and difficult to treat
Fibromyalgia affects approximately 4% to 7% of the population. It significantly affects a person’s physical functioning, cognitive abilities and sleep. In addition to chronic pain, a key feature of the condition is full-body fatigue, which interferes with daily life and contributes to patients’ inability to concentrate and perform functional activities.
Exercise is often the first line of treatment recommended for people with fibromyalgia, and research has shown that it can be beneficial. However, fibromyalgia causes fatigue and pain, which is a key reason why the research team focused on relieving pain with movement.
“Pain with movement interferes with a person’s ability to participate in an effective exercise program and go about their daily activities.” says Sluka.
Science translates into real benefit
Sluka and her colleagues have spent decades studying the biological mechanisms affected by TENS, developing the ideal parameters of TENS stimulation, and testing the effectiveness of TENS for the treatment of chronic pain and fatigue in human trials.
They have previously shown that under the ideal conditions of a randomized, controlled clinical trial, TENS combined with physical therapy can significantly reduce movement pain.
The new Fibromyalgia TENS in Physical Therapy (FM-TIPS) study was designed to test the effect of TENS in real-world conditions. The study was conducted in 28 outpatient physical therapy clinics in six health care systems in the Midwest and included 384 people of different ages, educational levels, and socioeconomic backgrounds. Almost 50% of the participants were from rural areas.
“It was a challenge to recruit participants for this study, but the clinics and physical therapists we worked with were wonderful. This would never have happened without them,” says Sluka.
Clinics were randomized to provide either physical therapy (PT) with TENS or physical therapy alone. In the PT-TENS group, participants were asked to use TENS for two hours a day for six months. This time could be split into short periods or done all at once. TENS electrodes were placed on the upper and lower back and delivered a mixed frequency signal at an intensity as strong as the participant could tolerate.
After 60 days, pain caused by movement during TENS treatment was significantly improved in the PT-TENS group. The addition of TENS also significantly reduced rest and rest pain and fatigue from movement. In contrast, participants who received only physical therapy had no change in movement-induced pain.
The response was also dose-dependent, with subjects using TENS daily for 60 days having the best results.
Unlike many pain medications that can become less effective over time as the body develops a tolerance to the drug, the study shows that over time, TENS maintained its ability to improve pain and fatigue to a significant degree.
After the primary endpoint at day 60, the PT-only group also received TENS, and all participants continued in the study for another four months.
“When we gave PT-only patients the TENS unit and they started using it, we also saw the same improvements as PT with TENS patients, which is powerful,” says Sluka.
Overall, the study showed that 80% of patients found TENS helpful. At six months, 80% were still using TENS once a week and over 70% reported feeling better after using TENS.
TENS adds benefit
Dana Dailey, PT, PhD, UI research assistant and first author of the study, notes that it’s important for people to realize that the benefit of TENS comes from using it as part of an overall treatment unit that includes physical therapy.
“Using TENS alone will not provide the same benefits,” says Dailey. “However, the study shows that TENS provides an additional benefit over and above any relief from other treatments. All study participants were also using pain medication and receiving physical therapy, yet TENS provided additional relief.”
Fibromyalgia often needs multiple interventions to help patients feel less pain and fatigue and improve their overall function. The new findings suggest that TENS could be particularly useful as part of a multifaceted approach because it can be safely and easily used as a self-management tool that uniquely targets movement-related pain and fatigue.
“Often, when you move a randomized, controlled clinical trial into a real-world setting, it doesn’t work because there are too many confounding factors. But this intervention still works,” says Sluka. “Not only did the treatment reduce pain on movement and fatigue during the trial period, but patients continued to use it at six months.”
The study team included researchers from the University of Iowa Health Care and the University of Iowa College of Public Health. University of Illinois Chicago and UI Health. Advanced Physiotherapy & Sports Medicine. Kepros Physical Therapy & Performance; Advanced Physical Therapy Associates; Big Stone Treatments; Rock Valley Physical Therapy; Iowa City VA Healthcare System; Grand Valley State University; and Vanderbilt University Medical Center.
The research was funded as part of the HEAL Initiative by the National Institute of Arthritis and Musculoskeletal and Skin Diseases.
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