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

Fibromyalgia Clinical Trial

Official title:

Biofeedback in Patients With Fibromyalgia - a Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02186756
• Other study ID #: PM-FMBFBack
• Status: Completed
• Phase: N/A
• First received: July 2, 2014
• Last updated: July 8, 2014
• Start date: April 2005
• Est. completion date: July 2006

Study information

• Verified date: July 2014
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 2006
• Est. primary completion date: July 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• EMG-Biofeedback and Usual care
Please refer to arm description

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Change from baseline to 3 months	No
Secondary	Fibromyalgia Impact Questionnaire (FIQ)		Change from baseline to End of Treatment (8 weeks after baseline)	No
Secondary	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.	Change from baseline to End of treatment (8 weeks after baseline)	No
Secondary	Short-Form 36 (SF-36)		Change from baseline to 3 months	No
Secondary	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).	End of Treatment (8 weeks after baseline)	No
Secondary	self-rated Patients' Global Clinical Impression of Change Score		3 months	No
Secondary	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.	Change from baseline to End of treatment (8 weeks after baseline)	No
Secondary	Beck Depression Inventory (BDI)		Change from baseline to 3 months	No
Secondary	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.	Change from baseline to 3 Months	No
Secondary	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.	Change from baseline to End of treatment (8 weeks after baseline)	No
Secondary	Tender Point Score		Change from baseline to 3 months	No
Secondary	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.	Change from baseline to End of treatment (8 weeks after baseline)	No
Secondary	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.	Change from baseline to End of Treatment (8 weeks after baseline)	No