Fibromyalgia
Conditions
Keywords
Fibromyalgia, Transcutaneous Electrical Nerve Stimulation (TENS)
Brief summary
Fibromyalgia as a clinical syndrome is defined by chronic widespread muscular pain, fatigue and tenderness with hyperalgesia to pressure over tender points. Pain associated with fibromyalgia can interfere with daily function, work, and social activities. Thus, 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. Although the etiology of fibromyalgia is unknown, there is clearly enhanced sensitization in the central nervous system pain pathways as demonstrating by decreases in pressure pain thresholds, reduced central inhibition, and enhanced temporal summation. Reducing pain in people with fibromyalgia would help increase the patient's ability to return to work, perform activities of daily living and thus improve the quality of life for the patient. Transcutaneous electrical nerve stimulation (TENS) is a modality utilized in physical therapy that delivers electrical stimulation through the skin and is used for both acute and chronic pain. TENS works by reducing central excitability and increasing central inhibition. Thus, the investigators hypothesize that application of Transcutaneous Electrical Nerve Stimulation (TENS) to patients with Fibromyalgia (FM) will reduce pain, reduce central excitability by restoring diffuse noxious inhibitory controls (DNIC), and reduce temporal summation and that this decrease in pain and/or central excitability will improve function. 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 with random assignment to three treatments: no treatment control, placebo TENS and active high frequency TENS. A secondary aim is to test the effect of decreased pain and central excitability on function in patients with Fibromyalgia.
Detailed description
The study will be a simple crossover design with the following three treatments (1) active TENS, (2) placebo TENS or (3) no treatment control randomly assigned. Subjects will draw the order for treatments (A, B, and C) out of a bowl at the initial testing session. This will determine the order of the testing. Each subject will receive all 3 treatments in random order. The following tools will be used to measure subject characteristics (Fibromyalgia Impact Questionnaire, Tampa Scale of Kinesiophobia), pain (McGill Pain Questionnaire and Visual Analogue Scale), central excitability (pressure pain thresholds, temporal summation and DNIC) and function (6 minute walk test, range of motion, sit to stand test).
Interventions
DEVICETENS
Active TENS, Placebo TENS and No Treatment TENS
Sponsors
American Physical Therapy Association
Dana Dailey
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* Fibromyalgia diagnosis by a physician * History of cervical or lumbar pain
Exclusion criteria
* TENS use in the last 5 years * Pacemaker * No use of opioids
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain at Rest Difference Score Pre-intervention and Post Intervention | 3 weeks | Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention. |
| Pain With Movement Difference Score Pre-intervention and Post Intervention | 3 weeks | Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PPT Cervical Region | 3 weeks | Pressure pain threshold cervical region (kPa) |
| PPT Lumbar Region | 3 weeks | Pressure pain threshold in lumbar region (kPa) |
| Fatigue at Rest Difference Score Pre-intervention and Post Intervention | 3 weeks | Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention. |
| 6 Minute Walk Test Average Change (Feet) | 3 weeks | 6 minute walk test average change (feet) before and after intervention |
| PPT for Anterior Tibialis | 3 weeks | Pressure pain threshold in leg (kPa) |
| Fatigue With Movement Difference Score Pre-intervention and Post Intervention | 3 weeks | Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention. |
Countries
United States
Participant flow
Recruitment details
Subjects (125) were screened for eligibility via telephone. 82 were excluded and 43 were consented and enrolled at the University of Iowa
Pre-assignment details
43 subjects were consented and enrolled to the cross over design study. Subjects were randomized to treatment group order after providing written consent. The three treatment groups for randomization order included: active TENS, placebo TENS and no treatment TENS.
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants This is a crossover study with three groups. Subjects completed each arm of the study in random order. | 43 |
| Total | 43 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 | FG005 |
|---|---|---|---|---|---|---|---|
| Washout (One Week) | Withdrawal by Subject | 0 | 0 | 0 | 0 | 2 | 0 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 1 Participants |
| Age, Categorical Between 18 and 65 years | 42 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 42 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 43 Participants |
| Region of Enrollment United States | 43 participants |
| Sex: Female, Male Female | 42 Participants |
| Sex: Female, Male Male | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 43 | 0 / 43 | 0 / 43 |
| other Total, other adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
| serious Total, serious adverse events | 0 / 43 | 0 / 43 | 0 / 43 |
Outcome results
Primary
Pain at Rest Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Pain at Rest Difference Score Pre-intervention and Post Intervention | 0.38 units on a scale | Standard Error 0.26 |
| Placebo TENS | Pain at Rest Difference Score Pre-intervention and Post Intervention | -0.74 units on a scale | Standard Error 0.25 |
| No TENS | Pain at Rest Difference Score Pre-intervention and Post Intervention | -0.47 units on a scale | Standard Error 0.26 |
Primary
Pain With Movement Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Pain and 10 Worst Pain Imaginable Pain was measured at rest before and after intervention.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Pain With Movement Difference Score Pre-intervention and Post Intervention | 1.11 score on a scale | Standard Error 0.26 |
| Placebo TENS | Pain With Movement Difference Score Pre-intervention and Post Intervention | 0.23 score on a scale | Standard Error 0.26 |
| No TENS | Pain With Movement Difference Score Pre-intervention and Post Intervention | 0.26 score on a scale | Standard Error 0.25 |
Secondary
6 Minute Walk Test Average Change (Feet)
6 minute walk test average change (feet) before and after intervention
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | 6 Minute Walk Test Average Change (Feet) | 41.85 feet | Standard Error 36.7 |
| Placebo TENS | 6 Minute Walk Test Average Change (Feet) | -40.48 feet | Standard Error 36.31 |
| No TENS | 6 Minute Walk Test Average Change (Feet) | -0.97 feet | Standard Error 36.01 |
Secondary
Fatigue at Rest Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Fatigue at Rest Difference Score Pre-intervention and Post Intervention | -0.09 units on a scale | Standard Error 0.21 |
| Placebo TENS | Fatigue at Rest Difference Score Pre-intervention and Post Intervention | -0.14 units on a scale | Standard Error 0.21 |
| No TENS | Fatigue at Rest Difference Score Pre-intervention and Post Intervention | 0.12 units on a scale | Standard Error 0.22 |
Secondary
Fatigue With Movement Difference Score Pre-intervention and Post Intervention
Visual Analog Scale 0-10 with 0 No Fatigue and 10 Worst Fatigue Imaginable Pain was measured at rest before and after intervention.
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | Fatigue With Movement Difference Score Pre-intervention and Post Intervention | 0.94 units on a scale | Standard Error 0.23 |
| Placebo TENS | Fatigue With Movement Difference Score Pre-intervention and Post Intervention | 0.39 units on a scale | Standard Error 0.24 |
| No TENS | Fatigue With Movement Difference Score Pre-intervention and Post Intervention | 0.04 units on a scale | Standard Error 0.23 |
Secondary
PPT Cervical Region
Pressure pain threshold cervical region (kPa)
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | PPT Cervical Region | 53.15 pressure score (kPa) | Standard Error 10.09 |
| Placebo TENS | PPT Cervical Region | 26.42 pressure score (kPa) | Standard Error 10.02 |
| No TENS | PPT Cervical Region | 19.39 pressure score (kPa) | Standard Error 10.06 |
Secondary
PPT for Anterior Tibialis
Pressure pain threshold in leg (kPa)
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | PPT for Anterior Tibialis | 62.86 pressure score (kPa) | Standard Error 18.34 |
| Placebo TENS | PPT for Anterior Tibialis | 38.98 pressure score (kPa) | Standard Error 21.85 |
| No TENS | PPT for Anterior Tibialis | 4.4 pressure score (kPa) | Standard Error 15.47 |
Secondary
PPT Lumbar Region
Pressure pain threshold in lumbar region (kPa)
Time frame: 3 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Active TENS | PPT Lumbar Region | 86.97 pressure score (kPa) | Standard Error 15.97 |
| Placebo TENS | PPT Lumbar Region | 34.89 pressure score (kPa) | Standard Error 15.91 |
| No TENS | PPT Lumbar Region | 33.23 pressure score (kPa) | Standard Error 15.95 |