Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 2 from baseline

The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

Baseline, Week 2 pre-treatment

Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 3 from baseline

The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

Baseline, Week 3 pre-treatment

Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 4 from baseline

The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

Baseline, Week 4 pre-treatment

Change in severity and functional impact of fibromyalgia symptoms as measured by FIQR at week 8 from baseline

The Revised Fibromyalgia Impact Questionnaire (FIQR) measures pain intensity and assesses how symptoms, including pain, interfere with a person's life. It is a 21-item, self-report questionnaire designed to evaluate the impact of fibromyalgia over the last seven days. The FIQR's assessment of pain intensity and interference is found within its three domains: Symptoms, Function and Overall Impact. By combining scores from these domains, the FIQR provides a comprehensive picture of how fibromyalgia symptoms, including pain intensity and interference, affect a patient's overall well-being. All questions are based on an 11-point numeric rating scale of 0 to 10, with 10 being 'worst'.

Baseline, Week 8

Change quantitative sensory testing (QST) as assessed by PPT immediately after treatment 1

A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.

Baseline, week 1 post treatment

Change in quantitative sensory testing (QST) as assessed by PPT immediately after treatment 4

A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.

Week 4 pre-treatment, week 4 post-treatment

Change in quantitative sensory testing (QST) as assessed by PPT at week 4 post treatment from baseline

A pressure pain threshold (PPT) PPT measurements will be taken with a hand-held Algomed algometer mounted with a 1-cm2 probe and calibrated in kilopascals. Pressure will be applied at a constant rate of 30 kPa/s to two different locations bilaterally:1) Upper trapezius muscle at midway point between the C7 spinous process and acromion; 2) Gluteal muscles at midway point between PSIS and greater trochanter. Three measurements will be taken at each site and averaged to determine the final value for that site. Measurements will be expressed in kPa with a range of 0-800. Lower scores indicate more severe impact.

Baseline, week 4 post- treatment

Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 1

A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.

Baseline, week 1 post treatment

Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick immediately after treatment 4

A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.

Week 4 pre-treatment, week 4 post-treatment

Change in quantitative sensory testing (QST) as assessed by temporal summation (TS) to pin prick at week 4 post treatment from baseline

A pin prick stimulator will be used to assess for TS at the same testing sites used for PPT. Subjects will first be exposed to a single stimulus, and then to 10 repetitive stimuli with an inter-stimulus interval (ISI) of 1 second applied within an area 1cm in diameter. Participants will be asked to rate the level of pinprick pain intensity using a numeric pain rating from 0-10 for the single stimulus, and then for the peak pain of the train of 10 stimuli. Two rounds of testing will be performed, and an average of the values will be calculated to obtain a single value for the single stimulus and the peak stimulus of the train. The ratio of the peak stimulus of the train to the single stimulus pain score will be calculated and used for analysis. Scores range from 0-10. Higher scores indicate more severe impact. Subjects will also report whether any aftersensations are present at either 15 or 30 seconds after each of the two trials.

Baseline, week 4 post treatment

Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 1

Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact

Baseline, week 1 post treatment

Change in quantitative sensory testing (QST) as assessed by CPM score immediately after treatment 4

Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact

Week 4 pre treatment, week 4 post treatment

Change in quantitative sensory testing (QST) as assessed by CPM score at week 4 post treatment from baseline

Conditioned pain modulation (CPM) will be assessed via a PPT test stimulus applied to the upper trapezius for three trials. The average of the three PPT trials at the upper trapezius collected during the conditioning stimulus will be subtracted from the average of the three PPT trials collected before the CPT. Measurements of PPT will be expressed in kPa with a range of 0-800. Lower scores on CPM indicate more severe impact

Baseline, week 4 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 1

Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Baseline, week 1 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) immediately after treatment 4

Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200.Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Week 4 pre treatment, week 4 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by Heart rate change during cold pressor task (CPT) at week 4 post treatment from baseline

Autonomic cardiovascular function measures of interest will include heart rate collected during the two conditions (before and during CPT). Measurements of HR will be expressed in BPM with a range of 0-200.Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the HR values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Baseline, week 4 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 1

Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Baseline, week 1 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) immediately after treatment 4

Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Week 4 pre treatment, week 4 post treatment

Change in autonomic cardiovascular testing (ACT) as assessed by change in systolic blood and diastolic pressure during cold pressor task (CPT) at week 4 post treatment from baseline

Autonomic cardiovascular function measures of interest will include blood pressure collected during the two conditions (before and during CPT). Measurements of blood pressure will be expressed in mmHg with a range of 0-200 for systolic and diastolic. Cardiovascular and sympathetic responses during each CPT will be calculated by subtracting the systolic and diastolic values collected during the 2nd minute of the CPT from the values collected during the rest period before the CPT. Lower scores on CPT indicate more severe impact.

Baseline, week 4 post treatment