Aromatherapy on Upper Limb Spasticity on Stroke Survivors

NCT ID: NCT07286825

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-01

Study Completion Date

2025-11-20

Brief Summary

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This study employed a double-arm, pre- and post-test design. Stroke survivors aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong between February and June 2025, and were divided into control and intervention groups. 10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks. The range of motion (ROM) of the upper limbs in three planes, i.e., abduction, flexion and extension and pain level and blood pressure were assessed before and after each massage session. Psychosocial well-being of elders was assessed at baseline and 4 weeks post-intervention using Generalised Anxiety Disorder (GAD-7) and Patient Health Questionnaire (PHQ-9).

Detailed Description

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Study design This study employed a double-arm, pre- and post-test design. The study was conducted in two RCHEs in Hong Kong under a non-government organisation, Po Leung Kuk (PLK).

Participants We took reference from a pilot RCT on the effect of aromatherapy acupressure on hemiplegic shoulder and motor power among stroke patients recruited 30 patients (15 control and 15 intervention) (Shin \& Lee, 2007). In our study, 30 elders aged 65 or above with post-stroke upper limbs spasticity were recruited from two RCHEs in Hong Kong and evenly divided in both control and intervention groups (please refer to CONSORT flowchart in Fig. 2). Among both groups, only two elders from the control group dropped out due to admission to hospital during the research period. Participants were considered eligible if: (1) he/she is communicable with either Chinese or English, and (2) suffering from upper-limb post-stroke spasticity. In addition, participants will be excluded if: (1) he/she is currently receiving aromatherapy massage therapies, (2) he/she has external wound on the massage areas.

An information sheet was given, and consent was sought from each carer and elder before the intervention. All elders and carers were free to withdraw consent at any time. Where possible, clarification on the specific area of withdrawal, but not obligatory. Previously collected data was use in the analyses.

Procedures A 10-minute massage was given on elders' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks (8 sessions in total). Massage steps and rhythm and intensity are standardised for all subjects. Range of motion (ROM) and pain level was measured before and after each session of massage and psychosocial well-being will be measured at baseline and 4 weeks after the intervention.

Upper limb massage steps were standardized as follow:

Effleurage was done on the upper limbs and shoulders with mild pressure using hands, which mould themselves to the shape of the body being massaged (Price et al., 2020). 5-Step massage was done with sweet marjoram massage oil on both upper limbs as well as shoulders (as shown below). Whole massage process lasted for 10-15 minutes.

Conditions

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Aromatherapy Spasticity as Sequela of Stroke

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil (intervention group) or plain fractionated coconut organic carrier oil (control group) for four weeks.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants
Participants are masked for the ingredient of massage oil.

Study Groups

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Intervention group

using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil

Group Type ACTIVE_COMPARATOR

massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil

Intervention Type COMBINATION_PRODUCT

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil.

Control group

using massage oil with plain fractionated coconut organic carrier oil

Group Type ACTIVE_COMPARATOR

plain fractionated coconut organic carrier oil

Intervention Type COMBINATION_PRODUCT

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using plain fractionated coconut organic carrier oil as massage oil.

Interventions

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massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using massage oil with a mixture of sweet marjoram essential oil and fractionated coconut organic carrier oil.

Intervention Type COMBINATION_PRODUCT

plain fractionated coconut organic carrier oil

10-minute massage was given on subjects' upper limbs two times per week by an IFPA aromatherapist using plain fractionated coconut organic carrier oil as massage oil.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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Inclusion Criteria

* he/she is communicable with either Chinese or English, and
* suffering from upper-limb post-stroke spasticity

Exclusion Criteria

* he/she is currently receiving aromatherapy massage therapies
* he/she has external wound on the massage areas.
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hong Kong Metropolitan University

OTHER

Sponsor Role lead

Responsible Party

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Dr Veronica LAI Sze Ki

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Sze Ki Veronica LAI, Dr

Role: PRINCIPAL_INVESTIGATOR

School of Nursing and Health Studies, Hong Kong Metropolitan Universit

Locations

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Hong Kong Metropolitan University

Hong Kong, , Hong Kong

Site Status

Countries

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Hong Kong

Other Identifiers

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RD/2024/2.20

Identifier Type: -

Identifier Source: org_study_id