Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000471987
Ethics application status
Approved
Date submitted
22/01/2020
Date registered
14/04/2020
Date last updated
14/04/2020
Date data sharing statement initially provided
14/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
The role of Substance P and inflammatory mediators in underlying mechanism of traditional Malay massage (urut Melayu) in reducing muscle stiffness and inflammation for stroke rehabilitation.
Scientific title
The role of Substance P and inflammatory mediators in underlying mechanism of traditional Malay massage (urut Melayu) in reducing muscle stiffness and inflammation for stroke rehabilitation.
Secondary ID [1] 300345 0
NIL
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stroke 315957 0
Condition category
Condition code
Stroke 314226 314226 0 0
Ischaemic
Stroke 315178 315178 0 0
Haemorrhagic

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The stroke patients in intervention group (Group A) will be treated by two certified practitioner of traditional Malay massage, with the treatment being applied within 60 minutes in one session only (immediate effect). The traditional Malay massage will applied on upper and lower limb (full body), and will be treated and focused more on affected side. The practitioner will follow the protocol of traditional Malay massage for stroke that has been provided for and approved by the Ministry of Health, Malaysia. The location will be held in Physiotherapy Department at KPJ Seremban Specialist Hospital, Malaysia.

The traditional Malay massage procedure involves all part of the body except head. Every parts of the body have its own technique. Oil massage will spread evenly the area that need to massage (follow the sequence of body part) to give smooth effect between therapist’s hand and patient’s skin during apply techniques. All techniques in each body parts will apply 5 times with pressure level of 3 except effleurage (pressure level of 2) and static pressure as well as friction using knuckles (pressure level of 4). Pressure level of massage is based on Walton’s scale.


First procedure will start in toes area which is apply on right side. The techniques used in toe are effleurage from toes to heel, followed by thumb stroking on lateral side of footprint, double thumb stroking on the middle footprint. Then, do friction using knuckles with slow motion from heel to toes. Each toe will apply thumb stroking techniques and lastly apply effleurage technique from toes to heel. After that, proceed on the left side using the same techniques.

The second part is calf area (below knee) which is apply on right side first. The technique includes effleurage that apply from lateral malleolus to popliteal fossa, thumb stroking (on lateral malleolus area), palmar kneading as well as hacking (the whole calf muscles). Effleurage is the last technique in calf area which is applies from lateral malleolus to popliteal fossa. After that, proceed on the left side using the same techniques.

Next part is thigh area (above knee). Do apply the techniques on right side area includes effleurage that applies from popliteal fossa to below buttock area, forearm stroking technique apply on the whole thigh muscles, basic kneading as well as hacking techniques on the whole thigh muscles. A last technique is effleurage will apply from popliteal fossa to below buttock area. After that, proceed on the left side using the same techniques.
Proceed to lower and upper back area. The techniques include in this area are effleurage (from lower back to upper trapezius), thumb stroking along the erector spinae muscle (each side), double thumb stroking on both sided along the erector spinae muscle. Then focus on right side from lower back to upper back area, apply palmar stroking and basic kneading. Same techniques are applied on the left side of lower back to upper back area. On the scapular area (right side), apply thumb stroking, thumb friction and rapid palmar stroking along the scapula blades. Same techniques are applied on the left scapula side. Next technique is give static pressure about 5 seconds using therapist’s palm with pressure scale of 4. After that, apply tapotement techniques from lower back to upper back area. Lastly is effleurage from lower back to upper back.

Last area is hand which is divided into shoulder, forearm and fingers. Do all the techniques on right side then followed with left side using the same techniques. The first technique is effleurage that will apply from fingertips to shoulder. Then apply palmar stroking from wrist to forearm and proceed to shoulder. After that, apply thumb stroking on fingers, wrist, forearm and shoulder area. Lastly do effleurage again from fingertips to shoulder.
Intervention code [1] 316623 0
Rehabilitation
Intervention code [2] 317038 0
Treatment: Other
Comparator / control treatment
The stroke patients in Group B (control) will undergo a relaxation treatment which patient will lying on plinth in supine position with both eyes closed for 30 minutes in one session only (immediate effect). During this position, a pillow will be placed under knee and head so that the patient feel more comfortable. No any massage provided during this technique.
Control group
Active

Outcomes
Primary outcome [1] 322619 0
The substance P level (pg/mL) in blood samples. These samples will be analysed using Human Substance P enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [1] 322619 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Primary outcome [2] 323136 0
The substance P level (pg/mL) in saliva samples. These samples will be analysed using Human Substance P enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [2] 323136 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [1] 379043 0
The level of inflammatory mediators (pg/mL) included TNF-alpha in blood samples assessed by using Human TNF-alpha enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [1] 379043 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [2] 380909 0
The level of inflammatory mediators (pg/mL) included is TNF-alpha in saliva samples assessed by using Human TNF-alpha enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [2] 380909 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [3] 380910 0
The level of inflammatory mediators (pg/mL) included is in blood samples assessed by using Human IL-1beta enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [3] 380910 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [4] 380911 0
The level of inflammatory mediators (pg/mL) included is IL-1beta in saliva samples assessed by using Human IL-1beta enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [4] 380911 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [5] 380912 0
The level of inflammatory mediators (pg/mL) included IL-8 in blood samples assessed by using Human IL-8 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [5] 380912 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [6] 380913 0
The level of inflammatory mediators (pg/mL) included IL-8 in saliva samples assessed by using Human IL-8 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [6] 380913 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [7] 380914 0
The level of inflammatory mediators (pg/mL) included monocyte chemotactic protein-1 (MCP-1) in blood samples assessed by using Human monocyte chemotactic protein-1 (MCP-1) enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [7] 380914 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [8] 380915 0
The level of inflammatory mediators (pg/mL) included monocyte chemotactic protein-1 (MCP-1) in saliva samples assessed by using Human monocyte chemotactic protein-1 (MCP-1) enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [8] 380915 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [9] 380916 0
The level of inflammatory mediators (pg/mL) included is IL-6 in blood samples assessed by using Human IL-6 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [9] 380916 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [10] 380917 0
The level of inflammatory mediators (pg/mL) included is IL-6 in saliva samples assessed by using Human IL-6 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [10] 380917 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [11] 380918 0
The level of inflammatory mediators (pg/mL) included is IL-10 in blood samples assessed by using Human IL-10 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [11] 380918 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [12] 380919 0
The level of inflammatory mediators (pg/mL) included is IL-10 in saliva samples assessed by using Human IL-10 enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [12] 380919 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [13] 380920 0
The level of inflammatory mediators (pg/mL) included is the soluble form of intercellular adhesion molecule (sICAM-1) in blood samples assessed by using Human intercellular adhesion molecule (sICAM-1) enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [13] 380920 0
The blood samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [14] 380921 0
The level of inflammatory mediators (pg/mL) included is the soluble form of intercellular adhesion molecule (sICAM-1) in saliva samples assessed by using Human intercellular adhesion molecule (sICAM-1) enzyme-linked immunosorbent assay (ELISA) kit.
Timepoint [14] 380921 0
The saliva samples will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [15] 380922 0
Muscle testing on deltoid muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [15] 380922 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment).
Secondary outcome [16] 380923 0
Muscle testing on biceps muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [16] 380923 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [17] 380924 0
Muscle testing on quadriceps muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [17] 380924 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [18] 380925 0
Muscle testing on hamstring muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [18] 380925 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [19] 380926 0
Muscle testing on tibialis anterior muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [19] 380926 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [20] 380927 0
Muscle testing on gastrocnemius muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [20] 380927 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [21] 380928 0
Muscle testing on wrist flexor muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [21] 380928 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [22] 380929 0
Muscle testing on wrist extensor muscles assessed by using microFET®2 Digital Handheld Dynamometer
Timepoint [22] 380929 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [23] 380930 0
Range of motion of wrist extension assessed by using goniometer
Timepoint [23] 380930 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [24] 380931 0
Range of motion of wrist flexion assessed by using goniometer
Timepoint [24] 380931 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [25] 380932 0
Range of motion of knee flexion assessed by using goniometer
Timepoint [25] 380932 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [26] 380934 0
Range of motion of hip flexion assessed by using goniometer
Timepoint [26] 380934 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [27] 380935 0
Range of motion of hip extension assessed by using goniometer
Timepoint [27] 380935 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [28] 380936 0
Range of motion of elbow flexion assessed by using goniometer
Timepoint [28] 380936 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [29] 380937 0
Range of motion of shoulder flexion assessed by using goniometer
Timepoint [29] 380937 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [30] 380938 0
The physical performance assessed by Short Physical Performance Battery (SPBB) protocol included chair raise test. There will be count how many times the patient can do within one minute.
Timepoint [30] 380938 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [31] 380939 0
The physical performance assessed by Short Physical Performance Battery (SPBB) protocol included balance test. The progression from feet together to semi tandem to full tandem will be recorded if patient can do within 10 seconds for each activity.
Timepoint [31] 380939 0
The progression will be taken before (pre-treatment) and immediately after treatment (post-treatment)
Secondary outcome [32] 380940 0
The physical performance assessed by Short Physical Performance Battery (SPBB) protocol included 8' walk test. test. The time will be recorded after patient complete this test
Timepoint [32] 380940 0
The reading will be taken before (pre-treatment) and immediately after treatment (post-treatment)

Eligibility
Key inclusion criteria
1. Subacute and chronic stroke
3. National Institute of Health Stroke (NIH) scores between 5 to 25 points.
4. Functional Ambulation Category (FAC) of 4 and 5.
5. The Body Mass Index (BMI) is 18.5 - 24.9 kg/m (normal weight)
6. Patient are able to follow command and instructions.
7. Patients are willing to participate in this study.
Minimum age
18 Years
Maximum age
60 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Patients are unable to follow command and instructions.
2. Patients having nerve compression or spinal disorder (eg. Spondylolisthesis, Herniated nucleus pulposus)
3. Infectious diseases such as AIDS/HIV, Tuberculosis, Bronchitis, Pneumonia.
4. Acute infections and inflammation such as gout, Rheumatoid Arthritis, Osteoarthritis, Appendicitis .
5. Vascular diseases such as Aneurysm, Varicose Vein, Venous Thrombosis, Hypertension.
6. Any type of post-surgery.
7. Loss of vision.
8. Cognitive, emotional and behavioral problem such as Dyslexia, Schizophrenia.
9. Skin problem or sensitive with any topical cream or oil massage.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
When patients are eligible in this study, they will be allocated in to either the intervention or control group (Group A and B) based on sealed opaque envelopes .
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The simple randomisation is achieved by sequentially numbered, sealed opaque envelopes containing the group allocation, which will be determined by a computer-generated random number.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size is calculated using Power and Sample Size (PS) software 3.1.2 version. The difference between the mean values of the intervention and control groups, and the standard deviation (post-massage) of substance P levels will be used as parameters for sample size calculation. Since there is no previous finding of the effect of traditional Malay massage on substance P for stroke cases, we chose the closest related result based on traditional Thai massage on back-pain patients reported by MacKawan et al.. Their study reported that the mean levels of substance P in the intervention group and control group are 50.43 pg/mL; 56.27 pg/mL, respectively (the difference in the mean values between the experimental and control groups is 5.84 pg/mL). Their findings also showed that the response within each subject group was normally distributed, with the highest recorded standard deviation being 8.3. The Type I error probability associated with this test of the null hypothesis is 0.05. A sample of 33 experimental subjects and 33 control subjects is therefore required to reject the null hypothesis that the population means of the experimental and control groups are equal, with a probability (power) of 0.8.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
30/06/2020
Actual
Date of last participant enrolment
Anticipated
31/10/2020
Actual
Date of last data collection
Anticipated
31/12/2020
Actual
Sample size
Target
66
Accrual to date
Final
Recruitment outside Australia
Country [1] 22254 0
Malaysia
State/province [1] 22254 0
Seremban

Funding & Sponsors
Funding source category [1] 304771 0
Government body
Name [1] 304771 0
Ministry of Education
Country [1] 304771 0
Malaysia
Primary sponsor type
Government body
Name
Ministry of Education
Address
Bahagian Perancangan Kecemerlangan IPT, Jabatan Pendidikan Tinggi,
Kementerian Pendidikan Malaysia,
Aras 7, No. 2, Menara 2,
Jalan P5/6, Presint 5,
62200 W.P. Putrajaya,
Malaysia
Country
Malaysia
Secondary sponsor category [1] 305085 0
None
Name [1] 305085 0
Address [1] 305085 0
Country [1] 305085 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305186 0
KPJ Healthcare University College (KPJUC) Research Ethics Committee
Ethics committee address [1] 305186 0
KPJ Healthcare University College,
Lot PT 17010 Persiaran Seriemas, Kota Seriemas,
71800 Nilai, Negeri Sembilan,
Malaysia
Ethics committee country [1] 305186 0
Malaysia
Date submitted for ethics approval [1] 305186 0
04/02/2019
Approval date [1] 305186 0
22/03/2019
Ethics approval number [1] 305186 0
KPJUC/RMC/SOP/EC/2019/226

Summary
Brief summary
A 2-arm randomized controlled trial will be conducted. A total of 66 participants will be randomly assigned into traditional Malay massage (Group A) or control groups (Group B). The study aim is to investigate the role of substance P, inflammatory mediators, muscle power, range of motion and physical performance in underlying mechanism of traditional Malay massage in reducing muscle stiffness and inflammation among stroke patients. The primary outcome measure for this study is to measure the level of substance P (pre- and immediately post-treatment) and other secondary outcome measure is to measure inflammatory mediators and physical abilities (pre- and immediately post-treatment) . This study hypothesize that traditional Malay massage could reduce substance P level and inflammatory mediators too as well as improving physical abilities among stroke patients.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 99534 0
A/Prof Dr Faizah Safina Binti Bakrin
Address 99534 0
School of Pharmacy
KPJ Healthcare University College,
Lot PT 17010 Persiaran Seriemas, Kota Seriemas,
71800 Nilai, Negeri Sembilan,
Malaysia
Country 99534 0
Malaysia
Phone 99534 0
+60192258796
Fax 99534 0
Email 99534 0
[email protected]
Contact person for public queries
Name 99535 0
Mrs Nurhanisah Binti Sejari
Address 99535 0
Postgraduate Lounge & Workstation,
Level 6, FSK 1,5,
Faculty of Health Sciences,
Universiti Teknologi MARA (UiTM), Campus Puncak Alam,
42300 Puncak Alam,
Selangor, Malaysia
Country 99535 0
Malaysia
Phone 99535 0
+60177797362
Fax 99535 0
Email 99535 0
[email protected]
Contact person for scientific queries
Name 99536 0
A/Prof Dr Long Chiau Ming
Address 99536 0
University Brunei Darussalam,
Jalan Tungku Link, Gadong BE1410,
Brunei
Country 99536 0
Brunei Darussalam
Phone 99536 0
+6737352245
Fax 99536 0
Email 99536 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
all of the individual participant data collected during the trial
When will data be available (start and end dates)?
beginning 4 months and ending 3 years following main results publication, no end date determined
Available to whom?
anyone who wishes to access it
Available for what types of analyses?
Any purposes
How or where can data be obtained?
access subject to approvals by Principal Investigator, Associate Professor Dr Faizah Safina Bakrin ([email protected])


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.