Trial Outcomes & Findings for Minocycline to Reduce Pain After Carpal Tunnel Release (NCT NCT02051296)

NCT ID: NCT02051296

Last Updated: 2018-06-11

Results Overview

the time until patient answers no pain at surgical site for three consecutive days

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 131 participants
• Primary outcome timeframe: up to 365 days
• Results posted on: 2018-06-11

Participant Flow

Participant milestones

Measure	Minocycline perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID for 5 days Minocycline: RCT blinded placebo trial	Placebo Placebo: two pills 2 hours prior to surgery then 1 pill BID placebo
Overall Study STARTED	66	65
Overall Study Received Allocated Intervention	59	58
Overall Study COMPLETED	58	56
Overall Study NOT COMPLETED	8	9

Reasons for withdrawal

Measure	Minocycline perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID for 5 days Minocycline: RCT blinded placebo trial	Placebo Placebo: two pills 2 hours prior to surgery then 1 pill BID placebo
Overall Study Lost to Follow-up	1	2
Overall Study withdraw prior to treatment	7	7

Baseline Characteristics

Minocycline to Reduce Pain After Carpal Tunnel Release

Baseline characteristics by cohort

Measure	Minocycline n=58 Participants perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID Minocycline: RCT blinded placebo trial	Placebo n=56 Participants PLacebo placebo	Total n=114 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	37 Participants n=5 Participants	34 Participants n=7 Participants	71 Participants n=5 Participants
Age, Categorical >=65 years	21 Participants n=5 Participants	22 Participants n=7 Participants	43 Participants n=5 Participants
Age, Continuous	60 years n=5 Participants	60 years n=7 Participants	60 years n=5 Participants
Sex: Female, Male Female	13 Participants n=5 Participants	9 Participants n=7 Participants	22 Participants n=5 Participants
Sex: Female, Male Male	45 Participants n=5 Participants	47 Participants n=7 Participants	92 Participants n=5 Participants
Region of Enrollment United States	58 participants n=5 Participants	56 participants n=7 Participants	114 participants n=5 Participants
Brief Pain Inventory(Short Form) Brief Pain Inventory Severity Score	5 units on a scale n=5 Participants	5 units on a scale n=7 Participants	5 units on a scale n=5 Participants
Brief Pain Inventory(Short Form) Brief Pain Inventory Interference Score	3 units on a scale n=5 Participants	4 units on a scale n=7 Participants	3 units on a scale n=5 Participants
screen for Posttraumatic Stess Symptoms(SPTSS)	10 units on a scale n=5 Participants	9 units on a scale n=7 Participants	9 units on a scale n=5 Participants
Quick Disability Arm Shoulder and Hand(qDASH) Quick Disability Arm Shoulder and Hand	35 units on a scale n=5 Participants	45 units on a scale n=7 Participants	41 units on a scale n=5 Participants
Quick Disability Arm Shoulder and Hand(qDASH) Arm Shoulder and Hand Work	44 units on a scale n=5 Participants	44 units on a scale n=7 Participants	44 units on a scale n=5 Participants
Quick Disability Arm Shoulder and Hand(qDASH) Arm Shoulder and Hand Play	50 units on a scale n=5 Participants	56 units on a scale n=7 Participants	50 units on a scale n=5 Participants
Beck Depression Inventory-II(BDI-II)	9 units on a scale n=5 Participants	8 units on a scale n=7 Participants	8 units on a scale n=5 Participants
RAND 36 Item Health Survey( short form(SF-36)) Physical Component Score	57 units on a scale n=5 Participants	58 units on a scale n=7 Participants	57 units on a scale n=5 Participants
RAND 36 Item Health Survey( short form(SF-36)) Mental Component Score	48 units on a scale n=5 Participants	47 units on a scale n=7 Participants	47 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: up to 365 days

Population: 94 CTR enrolled and randomized, 83 completed and reached endpoint (43 in minocycline group and 40 in placebo group) 37 TFR enrolled and randomized, 31 completed and reached endpoint (15 in minocycline group and 16 in placebo group)

the time until patient answers no pain at surgical site for three consecutive days

Outcome measures

Measure	Minocycline n=58 Participants perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID Minocycline: RCT blinded placebo trial	Placebo n=56 Participants PLacebo placebo
Time to Pain Resolution	17 DAYS Interval 3.0 to 365.0	15 DAYS Interval 3.0 to 365.0

Adverse Events

Minocycline

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Minocycline n=58 participants at risk perioperative minocycline for 5 days, starting 2 hours prior to surgery then 100mg BID Minocycline: RCT blinded placebo trial	Placebo n=56 participants at risk PLacebo placebo
General disorders dizziness	6.9% 4/58 • Number of events 5 • The patients were followed up for 6 months after surgery.	5.4% 3/56 • Number of events 4 • The patients were followed up for 6 months after surgery.

Additional Information

Dr Catherine Curtin

VA HCS Palo Alto

Phone: 650-493-5000

Email: ccurtin@stanford.edu

Results disclosure agreements

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