Information About The Study

Purpose of Study

The goal of this study is to determine if Transcutaneous Electrical Nerve Stimulation (TENS) is effective in a real-world physical therapy practice for individuals with fibromyalgia, neck and back pain. We will examine if TENS in addition to standard physical therapy reduces pain, increases participation in physical therapy, and increases function with less drug use.

Co–principal investigators Dr. Kathleen Sluka and Dr. Leslie Crofford discuss the FM TIPS Demonstration Project.

Dr. Leslie Crofford describes importance of clinical trials and importance to research

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Fibromyalgia

Fibromyalgia (FM) is a chronic pain condition characterized by widespread musculoskeletal pain accompanied by fatigue, sleep disturbance, and cognitive symptoms. Fibromyalgia is more common in women than men presenting most often in middle adulthood but occurs in individuals of all ages. Some of the common debilitating illness and conditions associated with fibromyalgia, neck and back pain

The mechanisms underlying fibromyalgia are complex but involve alterations pain processing in the central nervous system. It is also clear that psychological factors such as stress can enhance the pain experience in fibromyalgia. A number of other mechanisms are now being explored including alterations in the peripheral nervous system and the immune system. These have been reviewed in detail from the study of Neurobiology of Fibromyalgia and Chronic Widespread.

Many individuals with FM have reduced activity levels, and activity itself can increase pain. However exercise and staying active are important to reduce pain. Thus treatments aimed at reducing pain are important to improve participation in normal daily activities and exercise. In our prior randomized controlled clinical trial testing TENS in fibromyalgia we show that TENS use during activity, reduced activity-related pain.

TENS

Transcutaneous Electrical Nerve Stimulation (TENS) therapy is a non-drug treatment used at home and in physical therapy settings to decrease pain. TENS units are small and worn on a belt or in a pocket. The TENS unit connects to electrodes attached to the skin to deliver electrical impulses through the skin. TENS releases chemicals in your body that stop pain signals in the brain.

TENS reduces pain during movement or activity. Research shows that TENS is most helpful for chronic pain when used for 30 minutes everyday for 2 hours while active. It is less effective when sitting still, lying down, or resting. In our prior randomized controlled clinical trial testing TENS in fibromyalgia we show that TENS use during activity, reduced activity-related pain.

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Clinicians

Study Flow

  • The study begins with the initial physical therapy (PT) evaluation at one of our clinical sites during which participants randomized to one of two groups:  TENS or No TENS.

  • Participants continue PT as prescribed with those in the TENS group wearing the TENS during PT activities and at home.

  • Home activities and questionnaires are completed by the participant approximately once a month for 6 months  

PT Related Outcomes and Measures for FM-TIPS

  • Pain and fatigue ratings with movement and at rest

  • Patient Specific Functional Scale (PSFS)

  • Fibromyalgia Impact Questionnaire Revised (FIQR)