AzTrials
AzTrials

FibromyalgiaNCT02186756

A Randomized Controlled Trial to Evaluate the Effectiveness of Electromyography (EMG)-Biofeedback in Patients With Fibromyalgia

A study of Fibromyalgia, run by Ludwig-Maximilians - University of Munich.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia. Read more about this study

Who is it for?
Ages 18 to 65 years, women only
Conditions the study is for
Fibromyalgia
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
No sites listed yet
Study dates
Apr 2005to Jul 2006
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • fibromyalgia according to the American Congress of Rheumatology (ACR)-criteria and the criteria.
  • female gender
  • age between 18 and 65
  • cognitive ability and sufficient German language skills to fill in health status questionnaires
  • signed informed consent

Who cannot join

  • major medical disorders, i.e. cancer, chronic heart failure New York Heart Association (NYHA) IV or asthma requiring cortisone medication
  • suffering from psychosis or major affective disorders
  • substance abuse
  • co-medication with opiates or benzodiazepine
  • transmeridian flight in the last weeks
  • shift-work
  • gravity

About this study

Official title: Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial

The purpose of this study is to determine whether EMG-Biofeedback is effective in the treatment of Fibromyalgia.

Read the detailed description

The objective of this randomized controlled trial is to evaluate the effectiveness of EMG-biofeedback in patients with Fibromyalgia. The assessors are blinded to the group assignment. There are three time points of assessment: before intervention, at the end of treatment (T1) and 3-months follow-up (T2). Patients are recruited from the waiting list of the Fibromyalgia day hospital program at the University Hospital Munich fulfilling the inclusion criteria. The intervention group is treated with 14 sessions of EMG-biofeedback during eight weeks in addition to usual care. The control group receives usual care only. The main specific aim is to assess the change in fibromyalgia specific health status.

Conditions
Fibromyalgia
Being tested
EMG-Biofeedback and Usual care
Keywords
Fibromyalgia, Complementary Therapies, Biofeedback, Randomized controlled trial, Relaxation Therapy
Medical subject headings
Fibromyalgia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • EMG-Biofeedback and Usual careOther

    Also called Schuhfried Biofeedback apparatus

    Please refer to arm description

Study groups in NCT02186756
Study groupRoleWhat they receive
EMG-Biofeedback and Usual CareExperimentalPatients in the intervention group started EMG-biofeedback training within three days after inclusion. In total 14 sessions of EMG-biofeedback training were applied. They started with three sessions of therapy in week 1-3 and had one session per week in week 4-8. Patients were encouraged to do a home exercise program, in which they consciously relaxed the muscle analogously to the biofeedback session for about 15 minutes per day. Additionally, they should try to apply the techniques in stressful situations, for example appointments at the dentist's.
Receives: Other: EMG-Biofeedback and Usual care
Usual careNo interventionThe patients in the control group had only two encounters with the therapist in the eight week interval. At these encounters pain was assessed by a visual analogue scale and their trapezius muscle activity was measured during 5 minutes analogously to the intervention group. However, afterwards they did not continue with muscle straining and relaxation.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Fibromyalgia Impact Questionnaire (FIQ)

    The primary outcome measure was the Fibromyalgia Impact Questionnaire (FIQ). The FIQ is a disease specific multidimensional self-administered instrument that covers the dimensions physical functioning (11 items), well-being (1 item), work situation (2 items), pain (1 item), fatigue /sleep (2 items), stiffness (2 items) and psychological symptoms (2 items). Scoring ranges from 0 to 80 with the latter number being the worst case. The FIQ Total Score gives a summary of patients' impairment and is recommended as a highly sensitive measure of change in Fibromyalgia treatment programs and clinical studies. In this study the validated German version was used.

    Measured: Change from baseline to 3 months

Secondary outcomes (12)

  1. Fibromyalgia Impact Questionnaire (FIQ)

    Measured: Change from baseline to End of Treatment (8 weeks after baseline)

  2. Short-Form 36 (SF-36)

    The SF-36 is a widely used measure of health-related quality of life with 36 items. It yields an eight-scale profile of scores which are Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional and Mental Health.

    Measured: Change from baseline to End of treatment (8 weeks after baseline)

  3. Short-Form 36 (SF-36)

    Measured: Change from baseline to 3 months

  4. self-rated Patients' Global Clinical Impression of Change Score

    Change of health was directly measured by the self-rated Patients' Global Clinical Impression of Change Score, which is a validated measure of overall change compared with study onset, including six possible scores from "very much worse" (score 1) to "very much better" (score 6).

    Measured: End of Treatment (8 weeks after baseline)

  5. self-rated Patients' Global Clinical Impression of Change Score

    Measured: 3 months

  6. Beck Depression Inventory (BDI)

    This questionnaire was developed and validated for patients with depression and has been applied in clinical trials of patients with Fibromyalgia as well. It contains 21 items that assess the cognitive, affective and neurovegetative factors associated with depression.

    Measured: Change from baseline to End of treatment (8 weeks after baseline)

  7. Beck Depression Inventory (BDI)

    Measured: Change from baseline to 3 months

  8. Symptom Checklist 90 Revised (SCL-90-R)

    the Symptom Checklist 90 Revised (SCL-90-R) was used for measuring psychological distress. It generates 9 specific scales, one additional unspecific scale and three general scores. The 9 dimensions of the scale are as follows: SCL 1 = somatization; SCL 2 = obsessive-compulsive symptoms; SCL 3 = interpersonal sensitivity; SCL 4 = depression; SCL 5 = anxiety; SCL 6 = hostility; SCL 7 = phobic anxiety; SCL 8 = paranoid ideation; SCL 9 = psychoticism. The Global Severity Index serves as a measure of psychological distress.

    Measured: Change from baseline to 3 Months

  9. Tender Point Score

    It consists of a body diagram, where patients can rate the pain intensity at 24 locations of the front and the back side of the body. It allows calculating a total score for the whole body, as well as specific local scores.

    Measured: Change from baseline to End of treatment (8 weeks after baseline)

  10. Tender Point Score

    Measured: Change from baseline to 3 months

  11. Tender Point Count

    According to the Tender point manual the examiner applied discrete pressure of 4 kg/cm² to each of the 18 Fibromyalgia typical Tender Points. When the patients expressed pain, the tender point was considered positive.

    Measured: Change from baseline to End of treatment (8 weeks after baseline)

  12. Pressure Pain Threshold

    For measuring the Pressure Pain Threshold, the assessor first searched for an induration with pressure pain in the trapezius muscle pars descendens on each side of the muscle. The palpated part of the muscle was always located above or on a line between the acromioclavicular joint and the spinous process of vertebrae C 7. These two structures also served as coordinates to write down the exact place of the palpated taut band. Second, using a Fischer dolorimeter with a stamp of 1 cm², the examiner applied vertical pressure to the selected point and successively augmented the pressure until the patient signalled pain. In this way, the pressure pain threshold was measured in kg/cm².

    Measured: Change from baseline to End of Treatment (8 weeks after baseline)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2014 (estimated)
  2. Study startApr 2005
  3. Primary completionJul 2006
  4. Study completionJul 2006

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02186756
Sponsor's protocol ID
PM-FMBFBack
Status last verified
Jul 2014
First submitted
2 Jul 2014
Last updated
10 Jul 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study of Fibromyalgia, run by Ludwig-Maximilians - University of Munich.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fibromyalgia Impact Questionnaire (FIQ) (time frame: Change from baseline to 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02186756.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in