Efficacy of systolic extinction training (set) in fibromyalgia

Psychological pain treatment in fibromyalgia: Systolic Extinction Training (set) restores baroreflex sensitivity, reduces pain sensitivity and clinical pain report

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12087003

Enrollment

Registered

2015-06-22

Start date

2015-04-01

Completion date

Unknown

Last updated

2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia Nervous System Diseases Fibromyalgia

Interventions

1. The Systolic Extinction Training - SET - consists of the operant-behavioral pain therapy (OBT) and the baroreceptor stimulation as a cardiac gated, electrical, individual adjusted stimulation. Pain

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The inclusion criteria consist of: 1. Meeting ACR (American College of Rheumatology) criteria of FM 2. Pain for a period of at least 6 months 3. Married 4. Willingness of the spouse to participate 5. Ability to complete the questionnaires and understand the treatment components. Further essential inclusion criteria for the proposed tailored study are: 6. Cardiac hypertensive stress reactivity 7. High level of pain behaviors 8. Catastrophizing 9. Solicitous spouse responses

Exclusion criteria

Exclusion criteria: The exclusion criteria consisted of: 1. Inflammatory rheumatologic diseases and any concurrent major disease such as cancer, diabetes, or kidney failure 2. Intake of beta-blocker (systematic), opioids, anti-depressants)

Design outcomes

Primary

Measure	Time frame
1. Clinical pain. Clinical Pain will be measured before, after, 6 and 12 months after therapy using two methods: 1.1. using the visual analogue score (VAS) before and after psychophysiological experiment that we provide before, after, 6 and 12 months after therapy 1.2. using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, after, 6 and 12 months after therapy. 2. Physical impairment. Physical impairment / interference will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, therapy and then 6 and 12 months after therapy. 3. Affective distress (according to IMMPACT guidelines). Affective distress will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, after, 6 and 12 months after therapy.	—

Measure

Time frame

1. Clinical pain. Clinical Pain will be measured before, after, 6 and 12 months after therapy using two methods: 1.1. using the visual analogue score (VAS) before and after psychophysiological experiment that we provide before, after, 6 and 12 months after therapy 1.2. using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, after, 6 and 12 months after therapy. 2. Physical impairment. Physical impairment / interference will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, therapy and then 6 and 12 months after therapy. 3. Affective distress (according to IMMPACT guidelines). Affective distress will be measured by using the standardized questionnaire 'West Haven-Yale Multidimensional Pain Inventory" (MPI) before, after, 6 and 12 months after therapy.

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Secondary

Measure	Time frame
1. Baroreflex Sensitivity (BRS): BRS will be measured using Finapress for blood pressure and heart rate recording necessary for 3 different calculation procedures to receive the BRS in an psychophysiological experiment before therapy (T1), immediately after (T2), 6 (T3) and 12 months (T4) after therapy 2. Heart rate variability (HRV): HRV will be measured using 3 channel ECG and the Acq-knowledge software program (Biopac) for calcualtion the HRV components before therapy (T1), in an psychophysiological experiment immediately after (T2), 6 (T3) and 12 months (T4) after therapy 3. Evoked potentials: Evoked potentials (ep) will be measured using a 128 channel EEG that measures the ep's in regard to 6 different markers defined by stimuli intensities (pain-free, 50% and 75% of pain tolerance) and cardiac cycle 9sysytolic and diastolic peak) in an psychophysiological experiment immediately after (T2), 6 (T3) and 12 months (T4) after therapy	—

Measure

Time frame

1. Baroreflex Sensitivity (BRS): BRS will be measured using Finapress for blood pressure and heart rate recording necessary for 3 different calculation procedures to receive the BRS in an psychophysiological experiment before therapy (T1), immediately after (T2), 6 (T3) and 12 months (T4) after therapy 2. Heart rate variability (HRV): HRV will be measured using 3 channel ECG and the Acq-knowledge software program (Biopac) for calcualtion the HRV components before therapy (T1), in an psychophysiological experiment immediately after (T2), 6 (T3) and 12 months (T4) after therapy 3. Evoked potentials: Evoked potentials (ep) will be measured using a 128 channel EEG that measures the ep's in regard to 6 different markers defined by stimuli intensities (pain-free, 50% and 75% of pain tolerance) and cardiac cycle 9sysytolic and diastolic peak) in an psychophysiological experiment immediately after (T2), 6 (T3) and 12 months (T4) after therapy

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Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026