NCT01283997 · OUTCOME

The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.

Prevention of Treatment Induced Neuropathy in Multiple Myeloma · Source last updated 2024-06-13

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure: MEAN
Unit: mN
Interval / dispersion: Standard Deviation
Time frame: baseline and week 10

What was measured

Touch detection thresholds are determined using the up/down method with calibrated von Frey monofilaments, Starting with a 0.5mN force, the von Frey monofilament is applied for approximately 1 sec. If the subject fails to detect the stimulus, then the next higher force von Frey monofilament is applied. When the subject detects the presence of the stimulus, the next lower von Frey is administered. The up/down test sequence continues until the same force filament is detected for three additional applications. The force of that filament is then assigned as the touch threshold

Groups in this outcome

Placebo Group

Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.

Minocycline Group

Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

Group	Source count
Placebo Group	17
Minocycline Group	19

Reported measurements

Fingertips

Values in mN · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo Group	0.00	0.25	Not reported	Not reported	Not reported
Minocycline Group	0.06	0.28	Not reported	Not reported	Not reported

Thenar Eminence

Values in mN · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo Group	0.08	0.26	Not reported	Not reported	Not reported
Minocycline Group	0.13	0.27	Not reported	Not reported	Not reported

Volar Forearm

Values in mN · Interval/dispersion: Standard Deviation
Group	Value	Spread	Lower	Upper	Comment
Placebo Group	0.09	0.36	Not reported	Not reported	Not reported
Minocycline Group	-0.03	0.44	Not reported	Not reported	Not reported

Source statistical analyses

Group order, estimate direction, methods and comments are retained. No treatment ranking is inferred.

ci Lower Limit
-0.13
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.24
group Description
Difference in the measurements for touch by the fingertip
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.54
param Type
Mean Difference (Final Values)
param Value
0.06
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
-0.13
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.23
group Description
Difference in the measurements for touch by the palm
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.60
param Type
Mean Difference (Final Values)
param Value
0.05
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
-0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.15
group Description
Difference in the measurements for touch by the forearm
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.37
param Type
Mean Difference (Final Values)
param Value
-0.12
statistical Method
Wilcoxon (Mann-Whitney)

Complete source fields

analyses

ci Lower Limit
-0.13
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.24
group Description
Difference in the measurements for touch by the fingertip
group Ids
OG000
OG001
non Inferiority Type
SUPERIORITY
p Value
0.54
param Type
Mean Difference (Final Values)
param Value
0.06
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
-0.13
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.23
group Description
Difference in the measurements for touch by the palm
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.60
param Type
Mean Difference (Final Values)
param Value
0.05
statistical Method
Wilcoxon (Mann-Whitney)
ci Lower Limit
-0.40
ci Num Sides
TWO_SIDED
ci Pct Value
95
ci Upper Limit
0.15
group Description
Difference in the measurements for touch by the forearm
group Ids
OG000
OG001
non Inferiority Type
OTHER
p Value
0.37
param Type
Mean Difference (Final Values)
param Value
-0.12
statistical Method
Wilcoxon (Mann-Whitney)

classes

categories
measurements
group Id
OG000
spread
0.25
value
0.00
group Id
OG001
spread
0.28
value
0.06
title
Fingertips
categories
measurements
group Id
OG000
spread
0.26
value
0.08
group Id
OG001
spread
0.27
value
0.13
title
Thenar Eminence
categories
measurements
group Id
OG000
spread
0.36
value
0.09
group Id
OG001
spread
0.44
value
-0.03
title
Volar Forearm

denoms

counts
group Id
OG000
value
17
group Id
OG001
value
19
units
Participants

description

dispersion Type

Standard Deviation

groups

description
Participants received one pill by mouth on Day 1. Staring on Day 2, 2 times a day (every 12 hours) by mouth for 10 weeks.
id
OG000
title
Placebo Group
description
Participants received minocycline 200 mg orally for 1 dose, then 100 mg orally every 12 hours for 10 weeks beginning at initiation of induction therapy for multiple myeloma
id
OG001
title
Minocycline Group

param Type

MEAN

reporting Status

POSTED

time Frame

baseline and week 10

title

The Difference Between Touch Detection Thresholds From the Sensorimotor Evaluation at Baseline and After 10 Weeks of Induction Therapy.

type

PRIMARY

unit Of Measure

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Preserved source evidence · Not medical advice