search
Back to results

Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

Primary Purpose

Fibromyalgia, Chronic Pain, Depression

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
rTMS
Sham rTMS
Sponsored by
University of Washington
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Pain, Fatigue, Chronic Fatigue Syndrome, Chronic Fatigue-Fibromyalgia Syndrome, Depression, Major Depressive Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of chronic widespread pain as defined by the 1990 American College of Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain above and below the waist; pain on both right and left sides; pain at one axial site (e.g., head, neck, spine, or back)
  • Willing to remain on a stable medical regimen during the entire 6-week course of Phase 1 treatment and 8 weeks prior to rTMS treatment
  • Willing to undergo random assignment and able to attend treatment sessions
  • Willing to remain on a stable psychotherapy regimen if currently receiving psychotherapy that has been ongoing for at least 3 months prior to study entry

Exclusion Criteria:

  • Unable to maintain treatment as usual at stable doses for any medical or psychiatric conditions for 8 weeks prior to and during the study
  • Another medical condition associated with significant pain (e.g., diabetic neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease)
  • Any condition that might increase the risk of seizures from TMS
  • History of a seizure disorder or family history of a seizure disorder
  • Previous use of TMS
  • Involvement in litigation or disability that is related to fibromyalgia, chronic widespread pain, or depression
  • Current use of proconvulsant medications (e.g., bupropion)
  • Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g., aneurysm clips, pacemakers, neurostimulators)
  • History of head injury associated with loss of consciousness for more than 15 minutes, brain surgery, or lithium toxicity
  • History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic disorder, or post-traumatic stress disorder
  • Current substance abuse or dependence
  • Active suicidal intent or plan
  • Severe claustrophobia that would prevent MRI
  • Major depression with psychotic features or a current major depressive episode lasting longer than 5 years
  • Pregnant

Sites / Locations

  • Harborview Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active rTMS

Sham rTMS

Arm Description

Active rTMS involves administration of real rTMS to the patient.

Sham rTMS is a placebo or inactive form of rTMS for study control and comparison purposes.

Outcomes

Primary Outcome Measures

Gracely Box Intensity Rating Scale
The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.

Secondary Outcome Measures

Gracely Box Unpleasantness Scale
The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.
Hamilton Depression Rating Scale
The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.
Adverse Events
Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.

Full Information

First Posted
August 30, 2007
Last Updated
April 13, 2013
Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
search

1. Study Identification

Unique Protocol Identification Number
NCT00524420
Brief Title
Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain
Official Title
Transcranial Magnetic Stimulation (TMS) in the Treatment of Chronic Widespread Pain (CWP)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
December 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Washington
Collaborators
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
While acute pain after surgery or trauma comes on suddenly and lasts for a limited amount of time, chronic pain persists and can continue for months and even years. Repetitive transcranial magnetic stimulation (rTMS) uses a magnetic field to deliver a current to the brain and can affect brain activity. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing chronic widespread pain in women.
Detailed Description
Chronic widespread pain is characterized by musculoskeletal pain that lasts for at least 3 months, pain above and below the waist, pain on both the right and left sides, and pain in the head, neck, spine, or back. In addition to fatigue, chronic widespread pain is a hallmark feature of fibromyalgia. Significant physical and emotional effects usually accompany chronic widespread pain and fibromyalgia, making the development of effective treatments a priority. rTMS involves a neurophysiologic technique that directs a current into the brain by using a magnetic field to pass the scalp and skull safely and painlessly. Stimuli are applied to the same brain area several times per second during several consecutive seconds. rTMS has been found to be effective for treating certain types of chronic pain. The purpose of this study is to determine the effectiveness of rTMS treatment in reducing bodily pain associated with chronic widespread pain and/or fibromyalgia in women. Participants in this study will undergo a diagnostic interview, physical and neurological exam, electrocardiogram, magnetic resonance imaging, and blood and urine collection for screening purposes. Eligible participants will then be randomly assigned to receive either rTMS treatment or sham rTMS treatment. One-hour daily treatment sessions will occur over 15 days. After every five treatment sessions, participants will be interviewed about their pain and depression symptoms, and they will fill out questionnaires about pain, depression, fatigue, sleep, and exercise. Participants will also undergo pain threshold and tolerance testing of their right thumb. On a daily basis, participants will rate their level of pain using a 0 to 20 scale. Follow-up evaluations will occur 1, 4, and 12 weeks after treatment and will include a repeat interview and testing. After the follow-up evaluations, any participants who did not respond to the sham treatment will be offered a series of 15 real rTMS treatment sessions.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Chronic Pain, Depression
Keywords
Pain, Fatigue, Chronic Fatigue Syndrome, Chronic Fatigue-Fibromyalgia Syndrome, Depression, Major Depressive Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active rTMS
Arm Type
Experimental
Arm Description
Active rTMS involves administration of real rTMS to the patient.
Arm Title
Sham rTMS
Arm Type
Sham Comparator
Arm Description
Sham rTMS is a placebo or inactive form of rTMS for study control and comparison purposes.
Intervention Type
Device
Intervention Name(s)
rTMS
Other Intervention Name(s)
Neuronetics 2100 CRS rTMS System
Intervention Description
10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions at 120% motor threshold rTMS to left dorsolateral prefrontal cortex
Intervention Type
Device
Intervention Name(s)
Sham rTMS
Other Intervention Name(s)
Neuronetics 2100 rTMS and James Long Integrated Sham System
Intervention Description
10 Hz, 4-second trains, 26-second intertrain interval, 75 trains/session, 15 sessions of sham rTMS
Primary Outcome Measure Information:
Title
Gracely Box Intensity Rating Scale
Description
The BIRS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain intensity over time and was selected as the primary outcome variable. Each scale is a 20 point scale that has clear anchor points. Patients will be classified as responders if they have a 4 point drop or more on the BIRS. In order to be randomized, subjects were to have had a BIRS score of at least 8. Lower scores indicate less pain and higher scores indicate more pain. This measure was administered once a week at Baseline, at the end of weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS treatment.
Time Frame
Measured weekly
Secondary Outcome Measure Information:
Title
Gracely Box Unpleasantness Scale
Description
The BURS is reliable, valid, and sensitive measure that has been used in a number of studies of analgesics and studies of changes of pain unpleasantness over time. Each scale is a 20 point scale that has clear anchor points. Pain unpleasantness is different from pain intensity in that it assesses the affective and not the somatic aspect of the pain. Lower scores indicate less unpleasantness of pain and higher scores indicate more unpleasantness of pain. This measure was administered at Baseline, after weeks 1, 2, and 3 of TMS treatment, and 1 week post-TMS.
Time Frame
Measured weekly
Title
Hamilton Depression Rating Scale
Description
The research coordinator administered the Hamilton Depression Rating Scale-17 item to assess the level of depression on a weekly basis at baseline, weeks 1, 2, 3 of TMS treatment and 1 week post-TMS treatment. Higher scores indicate a higher level of depression. Scores range from 0-50 and scores greater than 20 generally indicate moderate depression. Scores between 0-7 are considered normal.
Time Frame
Measured weekly
Title
Adverse Events
Description
Adverse events (AEs) were collected by open report of emergent symptoms or illness during the study. This form is filled out during baseline, daily before each TMS session by the trained physician administering the TMS, and at each follow-up visit.
Time Frame
Measured daily

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of chronic widespread pain as defined by the 1990 American College of Rheumatology guidelines: chronic musculoskeletal pain for at least 3 months; pain above and below the waist; pain on both right and left sides; pain at one axial site (e.g., head, neck, spine, or back) Willing to remain on a stable medical regimen during the entire 6-week course of Phase 1 treatment and 8 weeks prior to rTMS treatment Willing to undergo random assignment and able to attend treatment sessions Willing to remain on a stable psychotherapy regimen if currently receiving psychotherapy that has been ongoing for at least 3 months prior to study entry Exclusion Criteria: Unable to maintain treatment as usual at stable doses for any medical or psychiatric conditions for 8 weeks prior to and during the study Another medical condition associated with significant pain (e.g., diabetic neuropathy, systemic lupus erythematosus, Rheumatoid arthritis, severe degenerative joint disease) Any condition that might increase the risk of seizures from TMS History of a seizure disorder or family history of a seizure disorder Previous use of TMS Involvement in litigation or disability that is related to fibromyalgia, chronic widespread pain, or depression Current use of proconvulsant medications (e.g., bupropion) Metal in the body that would prevent magnetic resonance imaging (MRI) or TMS (e.g., aneurysm clips, pacemakers, neurostimulators) History of head injury associated with loss of consciousness for more than 15 minutes, brain surgery, or lithium toxicity History of bipolar disorder, schizophrenia, obsessive compulsive disorder, panic disorder, or post-traumatic stress disorder Current substance abuse or dependence Active suicidal intent or plan Severe claustrophobia that would prevent MRI Major depression with psychotic features or a current major depressive episode lasting longer than 5 years Pregnant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David H. Avery, MD
Organizational Affiliation
University of Washington
Official's Role
Principal Investigator
Facility Information:
Facility Name
Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
17502802
Citation
Avery DH, Holtzheimer PE 3rd, Fawaz W, Russo J, Neumaier J, Dunner DL, Haynor DR, Claypoole KH, Wajdik C, Roy-Byrne P. Transcranial magnetic stimulation reduces pain in patients with major depression: a sham-controlled study. J Nerv Ment Dis. 2007 May;195(5):378-81. doi: 10.1097/NMD.0b013e31802f58d1.
Results Reference
background
Links:
URL
http://www.neuronetics.com/
Description
Click here for the Neuronetics, Inc. Homepage

Learn more about this trial

Transcranial Magnetic Stimulation for Treating Women With Chronic Widespread Pain

We'll reach out to this number within 24 hrs