Trial Outcomes & Findings for A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan (NCT NCT01914679)

NCT ID: NCT01914679

Last Updated: 2017-04-19

Results Overview

The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable. .

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)
• Results posted on: 2017-04-19

Participant Flow

Participant milestones

Measure	Sham and RINCE Treatment 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments). RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
Overall Study STARTED	17
Overall Study Began 12 Week Actual RINCE Treatment	17
Overall Study COMPLETED	12
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Sham and RINCE Treatment 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments), and 12 weeks of RINCE therapy (24 treatments). RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
Overall Study Lack of Efficacy	1
Overall Study Sponsor terminated study	4

Baseline Characteristics

A Prospective Evaluation of RINCE to Reduce Fibromyalgia Effects - University of Michigan

Baseline characteristics by cohort

Measure	Sham and RINCE Treatment n=17 Participants 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments). RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
Age, Categorical <=18 years	0 Participants n=93 Participants
Age, Categorical Between 18 and 65 years	17 Participants n=93 Participants
Age, Categorical >=65 years	0 Participants n=93 Participants
Sex: Female, Male Female	17 Participants n=93 Participants
Sex: Female, Male Male	0 Participants n=93 Participants

PRIMARY outcome

Timeframe: Assessed at Baseline (Week 1), Post-Sham (Week 5), Mid-Treatment (Week 10), Mid-Treatment (Week 14), Post-Treatment (Week 18)

Population: One participant missing from analysis at Week 14/Mid-Treatment/Visit 27 due to missed visit.

The units of measure represent self-reported average pain over the last 24 hours on a 0-100 pain rating scale where 0 is no pain and 100 is the worst pain imaginable.

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Outcome measures

Measure	Sham and RINCE Treatment n=12 Participants 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments). RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
Change in Patient 24-hour Recall Average Pain Intensity Post-Treatment (Week 18)	32.58 units on a scale Standard Deviation 24.52
Change in Patient 24-hour Recall Average Pain Intensity Baseline (Week 1)	66.42 units on a scale Standard Deviation 15.68
Change in Patient 24-hour Recall Average Pain Intensity Post-Sham (Week 5)	49.83 units on a scale Standard Deviation 29.46
Change in Patient 24-hour Recall Average Pain Intensity Mid-Treatment (Week 10)	37.50 units on a scale Standard Deviation 24.34
Change in Patient 24-hour Recall Average Pain Intensity Mid-Treatment (Week 14)	32.18 units on a scale Standard Deviation 23.17

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (week 1), week 6, week 18 and week 21

EEGs will be measured at the baseline, week 4, week 18 and week 21 visits.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline and up to 21 weeks

The MASQ and MCS questionnaires will be administered at Baseline (week 1), week 6, week 10, week 14, week 18 and week 21.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (week 1), week 6, and week 18

Subjects will undergo a neuroimaging scan at Baseline (week 1), week 6, and week 18. The scan will measure network connectivity during stimuli.

Outcome measures

Outcome data not reported

Adverse Events

Sham and RINCE Treatment

Serious events: 0 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Sham and RINCE Treatment n=17 participants at risk 4 weeks of inactive (sham) RINCE therapy involving no RINCE therapy (8 treatments) and 12 weeks of RINCE therapy (24 treatments). RINCE: The intervention is repeat applications of RINCE therapy. The sham is created by not delivering the therapy stimulation signal.
Injury, poisoning and procedural complications Loss of Balance Resulting in Fall	23.5% 4/17
Musculoskeletal and connective tissue disorders Leg cramp	5.9% 1/17
Infections and infestations Cough/Congestion	52.9% 9/17 • Number of events 10
General disorders Night Sweats	5.9% 1/17
Cardiac disorders Chest Pain	5.9% 1/17
Gastrointestinal disorders Stomach Flu (achiness, diarrhea, nausea, vomiting)	17.6% 3/17
Skin and subcutaneous tissue disorders Rash	5.9% 1/17
Ear and labyrinth disorders Tinnitis	5.9% 1/17
Skin and subcutaneous tissue disorders Skin Tenderness	5.9% 1/17
Infections and infestations Yeast Infection	5.9% 1/17 • Number of events 2
Psychiatric disorders Mental Fogginess	5.9% 1/17
Gastrointestinal disorders Food Poisoning	5.9% 1/17
Infections and infestations Sinus Infection	11.8% 2/17
General disorders Migraine	5.9% 1/17 • Number of events 2
Gastrointestinal disorders Vomiting	5.9% 1/17 • Number of events 2
Infections and infestations Itchy Ears/Throat	5.9% 1/17
Infections and infestations Sore Throat	11.8% 2/17 • Number of events 3
Psychiatric disorders Bad Dreams	5.9% 1/17
Gastrointestinal disorders Stomach Pain/Constipation	5.9% 1/17
Injury, poisoning and procedural complications Ankle Pain	5.9% 1/17
Gastrointestinal disorders Stomach Cramps	5.9% 1/17
Ear and labyrinth disorders Vertigo	5.9% 1/17
Musculoskeletal and connective tissue disorders Myalgia	5.9% 1/17
Eye disorders Difficulty Focusing Vision	5.9% 1/17
General disorders Shaking/Dizziness	5.9% 1/17

Additional Information

Daniel Clauw, MD

University of Michigan

Phone: 734-998-6901

Email: dclauw@med.umich.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place