Ischemic StrokeNCT02270294
Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
A study testing Thai traditional massage and No massage in people with Ischemic Stroke, run by Chulalongkorn University at 1 site in Thailand.
Trial summary
The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Ischemic Stroke
- What is being tested?
- Thai traditional massage and No massage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 14 participants
- Where
- 1 siteThailand
- Study dates
- 1 Oct 2014to 3 Aug 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A single ischemic stroke with Middle cerebral artery (MCA) stenosis
- Men or women age 50-80 years
- Physician's approvals to participate the study
- Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment
- The modified rankin scale level is 2 or 3
Who cannot join
- History of serious diseases
- Musculoskeletal diseases (Chronic arthritis, Lower spondylosis/spondylolisthesis with radiculopathy, Spinal deformity, Cervical spondylosis, Rheumatoid arthritis)
- Cardiovascular diseases (Poorly control hypertension, Heart disease class C and D)
- Neurological disorders (Peripheral neuropathy, Parkinson)
- Respiratory diseases (Chronic Obstructive Pulmonary Disease)
- Brain disorders (Cardioembolic, Severe dementia, Alzheimer's disease)
- Medical condition precluding taking Anticoagulant and Statin drug
- Temporal window were not found
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Sports Science, Chulalongkorn University
Pathumwan, Bangkok, 10330
About this study
The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.
- Conditions
- Ischemic Stroke
- Being tested
- Thai traditional massage, No massage
- Keywords
- Ischemic stroke, Thai traditional massage, Vascular function, Cerebral blood flow, Cerebrovascular reactivity
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Thai traditional massageOther
Also called Thai massage
Thai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes.
No massageOther
The participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Thai traditional massage | Experimental | Not described Receives: Other: Thai traditional massage |
| No massage | Sham comparator | Not described Receives: Other: No massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in cerebrovascular reactivity
- Cerebrovascular reactivity or cerebral CO2 reactivity test will be assessed using the ultrasound equipment (CX50, Philips, USA). Blood flow velocity (BFV) of the middle cerebral artery (MCA) will be measured during normocapnic, hypocapnic, and hypercapnic states. Subjects will be asked to wear nose clips and breathe only through a mouthpiece. Baseline (3 minutes) recordings will be taken during spontaneous breathing of room air and then subjects underwent 1 minute of maximal voluntary hyperventilation with a duty cycle of 1 second. The MCA-BFV will be recorded during the last 20 seconds of hyperventilation. After that, subjects will be asked to breathe air containing a mixture of 5 % CO2 and 21 % O2 balanced with nitrogen spontaneously for 3 minutes and the MCA-BFV will be recorded during the last minute of hypercapnia.
Measured: baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Secondary outcomes (4)
Change from baseline in stress indicators
- Serum cortisol will be measured with cortisol EIA kit (Enzo Life Science, Switzerland).
Measured: Baseline, Post-test (immediately: 0 min after finish massage intervention)
Change from baseline in stress indicators
- Heart rate variability (HRV) will be measured using the Heart rate monitoring (RS800CX, Polar Electro, Oy, Finland)
Measured: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Change from baseline in Peripheral arterial stiffness
- Pulse wave velocity measurement will be assessed with MD6 bidirectional transcutaneous Doppler probe (Hokanson, Bellevue, WA, USA). All subjects will be monitored with an EKG and PWV measurements in the computer and used as timing markers for PWV identification.
Measured: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Change from baseline in blood chemistry
- Nitric oxide (NO) will be measured in plasma samples with Colorimetric nitric oxide assay kit (Biovision, USA).
- Beta-endorphin will be measured in serum samples with the commercial assay kit (Beta-endorphin [bEP] BioAssay ELISA kit [Human], US Biological Life Science).
- Malondialdehyde (MDA) will be determined using thiobarbituric acid reaction.
Measured: baseline, Post-test (immediately: 0 min after finish massage intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2014 (estimated)
- Study start1 Oct 2014
- Primary completion31 Oct 2015
- Study completion3 Aug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic StrokeStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Assoc. Prof. Dr.Daroonwan Suksom, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02270294
- Sponsor's protocol ID
- SPSC-3
- Status last verified
- Apr 2018
- First submitted
- 14 Oct 2014
- Last updated
- 3 Apr 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Effects of Thai Traditional Massage on Cerebrovascular Reactivity in Ischemic Stroke Patients
- ClinicalTrials.gov ID
- NCT02270294
- Acronym / sponsor ID
- SPSC-3
- Conditions
- Ischemic Stroke
- Keywords
- Ischemic stroke, Thai traditional massage, Vascular function, Cerebral blood flow, Cerebrovascular reactivity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 1 Oct 2014 (actual)
- Primary completion
- 31 Oct 2015 (actual)
- Study completion
- 3 Aug 2016 (actual)
- First posted
- 21 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators hypothesize that Acute Thai traditional massage will yield beneficial effects on cerebrovascular reactivity in ischemic stroke patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thai traditional massage | Experimental | Other: Thai traditional massage |
| No massage | Sham comparator | Other: No massage |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- A single ischemic stroke with Middle cerebral artery (MCA) stenosis
- Men or women age 50-80 years
- Physician's approvals to participate the study
- Stroke experienced at least 7 days of ischemic stroke onset and no more than 6 months before study enrollment
- The modified rankin scale level is 2 or 3
Key exclusion criteria (8 listed)
- History of serious diseases
- Temporal window were not found
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Thai traditional massageAlso: Thai massageThai traditional massage treatment based on original Thai traditional massage at Wat Po was use in this study. The participants will be assigned to receive one time of Thai traditional massage one time. Thai traditional massage techniques consists of petrissage, friction, and passive stretching on head, neck, shoulders, arms, back and legs for 60 minutes. | Other | Thai traditional massage |
| No massageThe participants will be asked to lie down in relaxant position on bed without sleep for 60 minutes. | Other | No massage |
Primary outcome
Change from baseline in cerebrovascular reactivity
Time frame: baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
- Cerebrovascular reactivity or cerebral CO2 reactivity test will be assessed using the ultrasound equipment (CX50, Philips, USA). Blood flow velocity (BFV) of the middle cerebral artery (MCA) will be measured during normocapnic, hypocapnic, and hypercapnic states. Subjects will be asked to wear nose clips and breathe only through a mouthpiece. Baseline (3 minutes) recordings will be taken during spontaneous breathing of room air and then subjects underwent 1 minute of maximal voluntary hyperventilation with a duty cycle of 1 second. The MCA-BFV will be recorded during the last 20 seconds of hyperventilation. After that, subjects will be asked to breathe air containing a mixture of 5 % CO2 and 21 % O2 balanced with nitrogen spontaneously for 3 minutes and the MCA-BFV will be recorded during the last minute of hypercapnia.
4 secondary outcomes
Change from baseline in stress indicators
Time frame: Baseline, Post-test (immediately: 0 min after finish massage intervention)
Change from baseline in stress indicators
Time frame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Change from baseline in Peripheral arterial stiffness
Time frame: Baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.
Change from baseline in blood chemistry
Time frame: baseline, Post-test (immediately: 0 min after finish massage intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thai traditional massage and No massage in people with Ischemic Stroke, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in cerebrovascular reactivity (time frame: baseline, Post-test (immediately: 0 min after finish massage intervention, 60 min, 120 min, 24 Hrs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2018.