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Trial Outcomes & Findings for Treatment of Dysphagia Using the Mendelsohn Maneuver (NCT NCT00592761)

NCT ID: NCT00592761

Last Updated: 2018-03-20

Results Overview

Change in duration of superior elevation of hyoid bone.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

18 participants

Primary outcome timeframe

baseline and six weeks

Results posted on

2018-03-20

Participant Flow

Recruitment of participants occurred through The University of Arkansas for Medical Sciences Medical Center Speech Pathology Clinic and newspaper advertisements between February 2003 and February 2010.

Participants were only assigned to a group after their initial evaluation and no exclusions were necessary. Participants were each assigned to receive 2 weeks of treatment and two weeks of no treatment. Assignments were randomized so half began with treatment and half began with no treatment.

Participant milestones

Participant milestones
Measure
No Treatment Then Treatment
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
First Intervention (2 Weeks)
STARTED
9
9
First Intervention (2 Weeks)
COMPLETED
9
9
First Intervention (2 Weeks)
NOT COMPLETED
0
0
Second Intervention (2 Weeks)
STARTED
9
9
Second Intervention (2 Weeks)
COMPLETED
9
9
Second Intervention (2 Weeks)
NOT COMPLETED
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Treatment of Dysphagia Using the Mendelsohn Maneuver

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Entire Study Population
n=18 Participants
This includes all participants. Half received treatment then no treatment and have received no treatment then treatment.
Age, Categorical
<=18 years
0 Participants
n=93 Participants
Age, Categorical
Between 18 and 65 years
7 Participants
n=93 Participants
Age, Categorical
>=65 years
11 Participants
n=93 Participants
Sex: Female, Male
Female
7 Participants
n=93 Participants
Sex: Female, Male
Male
11 Participants
n=93 Participants

PRIMARY outcome

Timeframe: baseline and six weeks

Population: per protocol

Change in duration of superior elevation of hyoid bone.

Outcome measures

Outcome measures
Measure
No Treatment Then Treatment
n=18 Participants
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment
n=18 Participants
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Change in Duration of Superior Hyolaryngeal Movement
.213 seconds
Standard Deviation .154
.233 seconds
Standard Deviation .184

PRIMARY outcome

Timeframe: Baseline and 6 weeks

Change in the duration of maximum anterior movement of the hyoid bone during swallowing.

Outcome measures

Outcome measures
Measure
No Treatment Then Treatment
n=18 Participants
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment
n=18 Participants
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Change in Duration of Hyoid Maximum Anterior Excursion
.233 seconds
Standard Deviation .157
.247 seconds
Standard Deviation .161

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Oral Intake Ability was measure with the Dysphagia Outcome and Severity Scale. A 7 is normal and a 1 is complete inability to consume any food safely. The means reported for treatment and no treatment periods are mean changes in scores throughout the period.

Outcome measures

Outcome measures
Measure
No Treatment Then Treatment
n=18 Participants
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment
n=18 Participants
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Change in Oral Intake Ability
1.8 units on a scale
Standard Deviation .15
2.3 units on a scale
Standard Deviation .11

SECONDARY outcome

Timeframe: Baseline and 6 weeks

Change in duration of pre- and post-treatment duration of UES opening.

Outcome measures

Outcome measures
Measure
No Treatment Then Treatment
n=18 Participants
Participants received 2 weeks of no-treatment and then 2 weeks of treatment with the Mendelsohn manuever.
Treatment Then No Treatment
n=18 Participants
Participants received 2 weeks of treatment with the Mendelsohn manuever and then 2 weeks of no treatment.
Change in Duration of Opening of Upper Esophageal Sphincter
.584 seconds
Standard Deviation .159
.610 seconds
Standard Deviation .183

Adverse Events

No Treatment Then Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Treatment Then No Treatment

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gary McCullough

UAMS Medical Center

Phone: 501-852-7886

Results disclosure agreements

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