NCT00797732 · FLOW

Participant flow

A Pilot Study of Acupuncture Treatment for Dysphagia · Source last updated 2018-02-13

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

groups

description
The active intervention used a three-phase step-up protocol to gradually increase the body areas treated and needling intensity. Acupuncture needles (0.20x25mm) were inserted with a depth of 5-10 mm into predefined points based on a systematic literature review following the STRICTA guideline. Needles were stimulated to obtain the de qi sensation. An electroacupuncture (EA) device was connected at two acupoints. All needles remained in place for 30 minutes. The active acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; MacPherson H, Altman DG et al. PLoS Med 2010;7:e1000261\]
id
FG000
title
Active Acupuncture
description
The sham intervention was designed to be maximally inert and minimally invasive, while simulating most aspects of the active protocol. Sham needles (0.12x30mm) were inserted at 14 locations paralleling the same body regions needled in the active group; however, all sham point locations were off the pathways of traditional Chinese medicine acupuncture meridians and points. An identical but deactivated EA device was used following sham protocols previously used. The sham acupuncture was administered once every 2 weeks for 24 weeks, starting 2 weeks into CRT and ending at 20 weeks after CRT. \[Refs: Lu W, Wayne PM et al. Contemp Clin Trials 2012; 33; 700-711; Wayne PA, Krebs DE et al. Arch Phys Med Rehabil 2005; 86:2248-2255\]
id
FG001
title
Sham Acupuncture
description
Participants approached in the screening process but ultimately not randomized.
id
FG002
title
Screened Non-Randomized

periods

drop Withdraws
reasons
group Id
FG000
num Subjects
3
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
0
type
Withdrawal by Subject
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Lost to Follow-up
reasons
group Id
FG000
num Subjects
1
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
0
type
Death
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
7
type
Not meet inclusion criteria
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
24
type
Excluded due to time constraints
reasons
group Id
FG000
num Subjects
0
group Id
FG001
num Subjects
0
group Id
FG002
num Subjects
123
type
Refused to Participate
milestones
achievements
group Id
FG000
num Subjects
21
group Id
FG001
num Subjects
21
group Id
FG002
num Subjects
154
type
STARTED
achievements
group Id
FG000
num Subjects
18
group Id
FG001
num Subjects
18
group Id
FG002
num Subjects
0
comment
Evaluable for quality of life assessment.
type
Evaluable at Baseline
achievements
group Id
FG000
num Subjects
17
group Id
FG001
num Subjects
18
group Id
FG002
num Subjects
0
comment
Evaluable for quality of life assessment.
type
Evaluable at 20 Weeks
achievements
group Id
FG000
num Subjects
17
group Id
FG001
num Subjects
18
group Id
FG002
num Subjects
0
comment
Evaluable for quality of life assessment.
type
Evaluable at 12 Months
achievements
group Id
FG000
num Subjects
16
group Id
FG001
num Subjects
18
group Id
FG002
num Subjects
0
type
COMPLETED
achievements
group Id
FG000
num Subjects
5
group Id
FG001
num Subjects
3
group Id
FG002
num Subjects
154
type
NOT COMPLETED
title
Overall Study

pre Assignment Details

Since one primary aim was to assess feasibility as measured by recruitment the screening non-randomized count is included in the participant flow.

recruitment Details

Patients were screened for potential enrollment from January 2009 through December 2011.

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