Chronic Pain Clinical Trial
Official title:
Investigate the Efficacy and Effectiveness of Aromatherapy for the Management of Chronic Pain
Verified date | January 2019 |
Source | The Hong Kong Polytechnic University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
In recent decades, following an increased longevity in Hong Kong, there is a drastic increase
in the prevalence chronic conditions, including chronic pain, seems to be the main reasons of
suffering for many older adults. This condition not only pose a burden to the whole family
but also the healthcare system.
While conventional treatment of chronic pain using pharmacotherapy and non-pharmacological
treatments has been effective for managing symptoms, owing to the adverse side effects caused
by anti-psychotic drugs and the short effective period incurred by non-pharmacological
interventions, development of alternative and non-pharmacological approaches for the
management of pain is of urgent need. Research has shown that aromatherapy (both administered
through inhalation and therapeutic massage) has been effective in reducing showing
pain-relieving effects. These findings support the premise that aromatherapy and the
investigators hope to provide further evidence to support the use of aromatherapy as an
evidence-based mainstream intervention for pain relief in older adults with chronic pain.
Whilst there is sufficient evidence to support the effectiveness of aromatherapy, few studies
compared the effectiveness of the use of aromatherapy by inhalation and/or therapeutic
massage. The investigators aim to address the above research gaps on the clinical application
of aromatherapy on chronic pain, with a focus on comparing the differential effectiveness
between administration by inhalation and administration by therapeutic massage. The proposed
research aims to (1) test the efficacy and effectiveness of aromatherapy on the symptom
management of chronic pain in older adults; (2) compare the effects of aromatherapy-scent
(i.e., inhalation) and aromatherapy-touch (i.e., therapeutic massage) in older adults with
chronic pain. This study also explores the benefits of aromatherapy on cognitive functioning,
functional performance and social engagement as secondary outcomes.
A randomized, controlled, and single blinded trial is proposed. 120 older adults with chronic
pain will be randomly assigned to aroma inhalation (intervention), aroma-touch or wait-list
(control) treatments. Pain intensity and subjective changes in mood states (primary outcome),
cognitive functioning, functional performance and social engagement (secondary outcome) will
be assessed three times: pre-treatment, mid-treatment, post-treatment. If the study
hypotheses are supported, the findings will provide empirical support for a treatment option
that could improve manage the symptoms of patients diagnosed with chronic conditions, and
also improve cognitive functioning, functional performance, and social engagement of older
adults.
Status | Completed |
Enrollment | 100 |
Est. completion date | October 1, 2018 |
Est. primary completion date | September 20, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 60 Years and older |
Eligibility |
Inclusion Criteria: - 60 years of age or older - having a CMMSE score over or equal to 15 - having chronic pain or a widespread pain condition such as fibromyalgia for at least 3 months - be willing to participate in the research, with informed consent signed by their guardian or carer. Exclusion Criteria: - being allergic to essential oils - refusal to give consent - being over-sensitive to tactile stimulation - having a history of kidney and liver disease - no history of an epileptic seizure. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | The Hong Kong Polytechnic University | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The Hong Kong Polytechnic University |
Hong Kong,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Numerical Rating Scale (NRS) | Numerical Rating Scale (NRS) will be used to measure the changes of pain among three time points within four months. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable"). | the change from baseline to the completion of intervention (16 weeks later) | |
Secondary | Cantonese Version of the Mini-mental State Examination (CMMSE) | Cantonese Version of Mini-mental State Examination (MMSE) is a brief 30-point questionnaire used to assess the change of the cognitive functions among three time points at four months. The range of the score is from 0 point to 30 points, which a lower score indicates the worse cognitive functions. | baseline, 8 weeks after baseline, and 16 weeks after baseline | |
Secondary | Chinese Version of the Barthel Index-100 | Chinese Version of the Barthel Index-100 is used to measure the change of the performance in activities of daily living (ADL) among three time points at four months. Scores range from 0 to 100, with higher scores indicating greater independence. | baseline, 8 weeks after baseline, and 16 weeks after baseline | |
Secondary | Index of Social Engagement(ISE) | The change of the social engagement among three time points at four months will be measured using the 6-item index of social engagement (ISE). Total scores on the ISE can range from 0 to 6, with a higher score indicating a higher level of social engagement. | baseline, 8 weeks after baseline, and 16 weeks after baseline | |
Secondary | Profile of Mood States (POMS)- Shorterned Chinese Version | The Chinese abbreviated version of the Profile of Mood States will be used to subjective changes in mood states among three time points at four months. There are 40 items, where participants will rate on a scale of 0(not at all)-5(extremely) and higher score indicates more distress. | baseline, 8 weeks after baseline, and 16 weeks after baseline |
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