Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation (FAST)
| Status: | Completed |
|---|---|
| Conditions: | Fibromyalgia, Pain |
| Therapuetic Areas: | Musculoskeletal, Rheumatology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 11/17/2018 |
| Start Date: | September 30, 2013 |
| End Date: | April 2, 2018 |
Fibromyalgia Activity Study With Transcutaneous Electrical Nerve Stimulation
Pain associated with fibromyalgia interferes with daily function, work, and social activities
resulting in a decreased quality of life. People with fibromyalgia also have a significant
amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability
of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of
the main treatments for patients with fibromyalgia must focus on pain relief to allow the
person to function more independently both at home and at work. Transcutaneous electrical
nerve stimulation is used by health professionals to deliver electrical stimulation through
the skin for pain control. Basic science studies, from the PI's laboratory show that TENS
activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus
the ideal patient population for the treatment of TENS would be one in which there is
enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.
Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve
Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related
pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC),
and that this decrease in pain and/or central excitability will reduce fatigue and fear of
movement, thereby improving function and quality of life
resulting in a decreased quality of life. People with fibromyalgia also have a significant
amount of fatigue and a fear of movement. People with fibromyalgia show enhanced excitability
of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of
the main treatments for patients with fibromyalgia must focus on pain relief to allow the
person to function more independently both at home and at work. Transcutaneous electrical
nerve stimulation is used by health professionals to deliver electrical stimulation through
the skin for pain control. Basic science studies, from the PI's laboratory show that TENS
activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus
the ideal patient population for the treatment of TENS would be one in which there is
enhanced central excitability and reduced inhibition; fibromyalgia is such a condition.
Hypothesis: The investigators hypothesize that application of Transcutaneous Electrical Nerve
Stimulation (TENS) to patients with fibromyalgia will reduce resting and movement-related
pain and reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC),
and that this decrease in pain and/or central excitability will reduce fatigue and fear of
movement, thereby improving function and quality of life
This is a phase II randomized, double-blind, placebo controlled multi-center clinical trial
involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a
non-pharmacological agent which delivers electrical stimulation by a battery operated device
via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and
non-invasive modality used to treat a variety of acute and chronic pain conditions. The
initial phase of the study will randomly allocate subjects to receive active TENS, placebo
TENS or standard care (No TENS). After participating in the 1 month random assignment, all
subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic
approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional
tasks, accelerometry, TENS, pain and fatigue assessments.
Study Aims:
Aim #1: The primary aim of the study is to test the effect of the long-term use of TENS on
movement-related pain as measured by a numeric rating scale (NRS) during six minute walk test
(6MWT) in women with fibromyalgia with random assignment to three treatments: standard care
(No TENS), placebo TENS and active TENS.
Aim #2: A secondary aim will test if movement-pain reduction by TENS results in a concomitant
decrease in fear of movement, fatigue, resting pain and analgesic medication and an increase
in function and quality of life. Outcome measures will include physical function by directly
assessing daily activity with an accelerometer, self-report (IPAQ), as well as performing
specific function tasks. A sub-analysis will determine responders and non-responders to TENS
and factors that predict both responders and non-responders. Multiple factors that could
contribute to TENS response include self-efficacy, pain catastrophizing, levels of physical
activity, fear of movement, sleep, pain, fatigue, function, quality of life, or pain
physiology.
Aim #3: To determine if active TENS alters pain processing in women with fibromyalgia and if
improvement in clinical symptoms correlates with normalization of pain processing physiology.
We will evaluate change in these physiologic parameters in responders versus non-responders
as assessed clinically.Pain processing will be assessed by examining pressure pain thresholds
at the site and outside the site of stimulation and by examining conditioned pain modulation
Aim #4: To determine if PROMIS (patient reported outcome measurement information system) is a
useful instrument for assessing outcomes in women with fibromyalgia by comparing the PROMIS
modules to symptom domains measured by other instruments validated for use in fibromyalgia
clinical trials and by determining the performance of PROMIS in the definition of responders.
involving a device, Transcutaneous Electrical Nerve Stimulation (TENS). TENS is a
non-pharmacological agent which delivers electrical stimulation by a battery operated device
via electrodes placed on the skin. TENS is considered to be a safe, inexpensive and
non-invasive modality used to treat a variety of acute and chronic pain conditions. The
initial phase of the study will randomly allocate subjects to receive active TENS, placebo
TENS or standard care (No TENS). After participating in the 1 month random assignment, all
subjects will receive active TENS for 1 month. The subjects will make 4 visits to the clinic
approximately 2 to 3 1/2 hours each visit. Visits will entail questionnaires, functional
tasks, accelerometry, TENS, pain and fatigue assessments.
Study Aims:
Aim #1: The primary aim of the study is to test the effect of the long-term use of TENS on
movement-related pain as measured by a numeric rating scale (NRS) during six minute walk test
(6MWT) in women with fibromyalgia with random assignment to three treatments: standard care
(No TENS), placebo TENS and active TENS.
Aim #2: A secondary aim will test if movement-pain reduction by TENS results in a concomitant
decrease in fear of movement, fatigue, resting pain and analgesic medication and an increase
in function and quality of life. Outcome measures will include physical function by directly
assessing daily activity with an accelerometer, self-report (IPAQ), as well as performing
specific function tasks. A sub-analysis will determine responders and non-responders to TENS
and factors that predict both responders and non-responders. Multiple factors that could
contribute to TENS response include self-efficacy, pain catastrophizing, levels of physical
activity, fear of movement, sleep, pain, fatigue, function, quality of life, or pain
physiology.
Aim #3: To determine if active TENS alters pain processing in women with fibromyalgia and if
improvement in clinical symptoms correlates with normalization of pain processing physiology.
We will evaluate change in these physiologic parameters in responders versus non-responders
as assessed clinically.Pain processing will be assessed by examining pressure pain thresholds
at the site and outside the site of stimulation and by examining conditioned pain modulation
Aim #4: To determine if PROMIS (patient reported outcome measurement information system) is a
useful instrument for assessing outcomes in women with fibromyalgia by comparing the PROMIS
modules to symptom domains measured by other instruments validated for use in fibromyalgia
clinical trials and by determining the performance of PROMIS in the definition of responders.
Inclusion Criteria:
- Participants will be 18 to 70 years of age
- Women may participate in the study, with the understanding that within the clinical
population of fibromyalgia the there is a 7:1 ratio of female to male.
- Diagnosis of Fibromyalgia by 1990 ACR criteria (11/18 tender points)
- History of cervical or lumbar pain with fibromyalgia (this is expected in all patients
since axial pain is required for diagnosis)
- Current stable treatment regimen for the last 4 weeks and projected stable treatment
regimen for the next 2 months.
- English speaking
Exclusion Criteria:
- Current or history of cardiovascular, pulmonary, neurological, endocrine, or renal
disease that would preclude the involvement in the study.
- TENS use in the last 5 years
- Pacemaker
- Uncontrolled blood pressure or diabetes
- Neuropathic pain condition
- Systemic autoimmune disorder (Lupus, PMR, RA, Psoriasis, Psoriatic arthritis)
- Spinal fusion - cervical or lumbar
- Metal implants in cervical or lumbar region
- Severe skin allergy to adhesive
- Allergy to nickel
- Pain level less than 4
- Pregnancy
- Epilepsy
- Change in or new drug or treatment program within the last month or in the next
2months, i.e. must have a stable treatment plan
- Unstable medical or psychiatric condition which in the opinion of the investigator
could compromise the subject's welfare or confound the study results
We found this trial at
2
sites
2201 West End Ave
Nashville, Tennessee 37232
Nashville, Tennessee 37232
(615) 322-7311
Principal Investigator: Leslie J Crofford, MD
Phone: 615-322-4746
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