Trial Outcomes & Findings for Pilot Study to Evaluate Ear Acupressure Effects in Treating Seasonal Allergic Rhinitis (NCT NCT01921348)

Results Overview

RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment). In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum. Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

18 participants

Primary outcome timeframe

8 weeks

Results posted on

2017-06-27

Participant Flow

Participant milestones

Participant milestones
Measure	Treatment 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.	Sham 33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.
Overall Study STARTED	9	9
Overall Study COMPLETED	8	7
Overall Study NOT COMPLETED	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Treatment 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.	Sham 33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.
Overall Study Withdrawal by Subject	1	0
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Treatment n=9 Participants 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.	Sham n=9 Participants 33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.	Total n=18 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	0 Participants n=7 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	0 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	9 Participants n=7 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	18 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.
Age, Categorical >=65 years	0 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	0 Participants n=7 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.	0 Participants n=5 Participants • There were no controls (i.e. non treated) individuals int his study. All participants were randomized to either an active or sham acupressure group.
Age, Continuous	41.9 years STANDARD_DEVIATION 12.1 • n=5 Participants	36.9 years STANDARD_DEVIATION 12.1 • n=7 Participants	39.4 years STANDARD_DEVIATION 12.0 • n=5 Participants
Sex: Female, Male Female	8 Participants n=5 Participants	9 Participants n=7 Participants	17 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Region of Enrollment United States	9 participants n=5 Participants	9 participants n=7 Participants	18 participants n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks

Population: Enrollment targets were not met for both arms/groups.

RQLQ is an instrument that has 28 items in 7 domains (sleep, non-rhinoconjuctivitis symptoms, practical problems, nasal symptoms, eye symptoms activity limitations and emotional function). Participants are asked to recall impairments experienced during the previous week and to respond to each item on a 7-point scale (0=no impairment; 6=maximum impairment). In this protocol, we used the nasal symptoms domain only; 4 questions, total scale ranges from 0 minimum to 24 maximum. Longitudinal changes of nasal symptoms domain total were reported from baseline to 8 weeks.

Outcome measures

Outcome measures
Measure	Treatment n=8 Participants 34 participants will be randomized to wear acupressure pellets in the designated acupressure points and apply pressure as instructed by the study personnel. acupressure pellets: The treatment group will have acupressure pellets placed in pre-determined acupressure point on the ear that relates to rhinitis.	Sham n=7 Participants 33 participants will be randomized to wear acupressure pellets in non-specific areas of the ear and apply pressure as instructed by the study personnel. acupressure pellets: The sham group will have acupressure pellets placed in a pre-determined non-specific acupressure point on the ear that is not related to rhinitis.
Rhinoconjunctivitis Quality of Life Questionnaire (Nasal Symptoms Domain Only)	2.36 units on a scale Standard Deviation 0.89	2.07 units on a scale Standard Deviation 1.31

SECONDARY outcome

Timeframe: 8 weeks

Population: Since the immune biomarker frozen blood samples were not analyzed (due to not meeting recruitment goals), the effects of ear accupressure based upon psychological differences could not be analyzed.

Effects of ear acupressure on immune biomarkers based upon psychological differences including perceived stress, anxiety, depression and worry.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 8 weeks

Population: Blood samples were collected and frozen for batch analysis, but not analyzed for data since recruitment goals were not met.

Changes in Regulatory T(Treg), Type 1 Regulatory T (Tr1), T helper 3(TH3), T helper 1(TH1), T helper 2(TH2)cells, salivary cortisol, alpha amylase, Interferon gamma(IFNg), Interleukin 4(IL4) and Interleukin 10(IL10) cytokine production from baseline to 8 weeks.

Outcome measures

Outcome data not reported

Adverse Events

Treatment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham

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

Gailen D. Marshall, Jr., MD, PhD, Director, Division of Clinical Immunology and Allergy

University of MS Medical Center

Phone: 6018155527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place