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Trial registered on ANZCTR


Registration number
ACTRN12616001511426
Ethics application status
Approved
Date submitted
29/07/2016
Date registered
1/11/2016
Date last updated
17/10/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Massage´s effectiveness by using helenalin cream in patients with musculoskeletal injury.
Scientific title
Massage´s effectiveness by using helenalin cream in patients with musculoskeletal injury.
Secondary ID [1] 289800 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Musculoskeletal injuries 299706 0
Other injuries and accidents 300209 0
Condition category
Condition code
Musculoskeletal 299645 299645 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300208 300208 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Estimating corporal injuries through previous quantitative and qualitative measurements after a physiotherapy treatment.
Carrying out a survey to the different testers: cream´s characteristics to clinical staff, patients and students of physiotherapy.
Before applying the cream, several studies will be carried out:
- Active mobility test
- Passive mobility test
- VAS scale
- Algometer measurement
When talking about the materials, creams, massage tables, gloves and sheet will be used.
The intervention will be delivered individually face to face by therapist with minimum 5 years’ experience. The duration will be 20 minutes per session once a day for two weeks. The timepoint is once a day Monday to Friday. The type of massage is massotherapy. The intervention will occur in urban clinics. The cream will be applied in treated body areas.
The massotherapy tecnique will begin with a superficial effleurage, followed by a deeper massage, moving deep tissues, muscular and conjunctive tissues.
The name of the cream is Physiorelax TM with Helenalin and the name of the placebo cream is the same than the other one but without the active ingredient. Physiorelax TM is in charge of supplying the cream.
After analysing the surveys´ results, physiotherapists measure if the cream is suitable for the patient or not and on the other hand they show if it is good for themselves.
Taking into account the results, we will carry out a more complex survey through general public.
Intervention code [1] 295471 0
Rehabilitation
Intervention code [2] 295472 0
Treatment: Other
Comparator / control treatment
Subjects in the Control Group followed exactly the same process for the treatment but with a different cream. The placebo cream is the same than Physiorelax TM but without the active ingredient.
Control group
Placebo

Outcomes
Primary outcome [1] 299110 0
To check the massage´s effectiveness by using the creams in patients with musculoskeletal injury with the VAS scale and the Algometer
Timepoint [1] 299110 0
The treatment will be followed daily during 10 days, from Monday to Friday for two weeks. The cream will be applied while each treatment session.
The assessment of the cream will be developed the last day of the treatment.
Primary outcome [2] 299111 0
To analyse the consumer´s behaviour when using the cream by developing a predictional model about their behaviour.
Semistructural surveys and consumers test will be used.
The surveys will be created just for the cream assessment; the valuation will be measured by a Likert scale.
Timepoint [2] 299111 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream will be developed the last day of the treatment.
Secondary outcome [1] 326216 0
To determine if there is an improvement in massotherapies’ treatments using the cream. The cream will be applied while each treatment session.
The assessment of the cream will be carried out the last day of the treatment.using the VAS scale and the Algometer
Timepoint [1] 326216 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream will be carried out the last day of the treatment using the VAS scale and the Algometer.
Secondary outcome [2] 326217 0
To determine the motivations when buying the cream by developing a predictional model about their behaviour.
Semistructural surveys and consumers test will be used.
The surveys will be created just for the cream assessment; the valuation will be measured by a Likert scale.
Timepoint [2] 326217 0
Immediately after each massage session.
Secondary outcome [3] 327607 0
To measure neural excitability by Hoffman reflex
Timepoint [3] 327607 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream and Hoffman reflex will be carried out the last day of the treatment
Secondary outcome [4] 327608 0
To measure changes in parasympathetic activity by heart rate with and electrocardiogram.
Timepoint [4] 327608 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream, the Hoffman reflex and the heart rate will be carried out the last day of the treatment.
Secondary outcome [5] 327609 0
To measure heart rate will be assessed using and electrocardiogram.
Timepoint [5] 327609 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream and heart rate will be carried out the last day of the treatment.
Secondary outcome [6] 327610 0
To measure changes in hormone levels by cortisol levels will be assessed using serum cortisol levels.
Timepoint [6] 327610 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session.
The assessment of the cream and the cortisol levels will be carried out the last day of the treatment.
Secondary outcome [7] 328420 0
To measure blood pressure using shpygmomanometry
Timepoint [7] 328420 0
The treatment will be followed during 10 days from Monday to Friday for two consecutive weeks. The cream will be applied while each treatment session. Blood pressure will be assessed the first day of the treatment as well as the last day of the treatment.

Eligibility
Key inclusion criteria
Inclusion criteria will be subjects of both sexes who have musculoskeletal injuries aged between 18 and 65 years,
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No treatment with Nonsteroidal anti-inflammatory drugs (NSAIDs) during the 10 days of the treatment
No cancer
No infectious diseases
Pregnant women

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/11/2016
Actual
5/12/2016
Date of last participant enrolment
Anticipated
Actual
28/04/2017
Date of last data collection
Anticipated
Actual
31/08/2017
Sample size
Target
200
Accrual to date
Final
200
Recruitment outside Australia
Country [1] 8064 0
Spain
State/province [1] 8064 0
Madrid

Funding & Sponsors
Funding source category [1] 294185 0
University
Name [1] 294185 0
Camilo Jose Cela University
Country [1] 294185 0
Spain
Primary sponsor type
University
Name
Camilo Jose Cela University
Address
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
28692 Madrid
Country
Spain
Secondary sponsor category [1] 293011 0
Commercial sector/Industry
Name [1] 293011 0
Physiorelax
Address [1] 293011 0
Calle La Fresa, 6
Poligono Industrial La Hoya
28703 San Sebastian de los Reyes
Country [1] 293011 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 295586 0
Camilo Jose Cela University
Ethics committee address [1] 295586 0
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
Villanueva de la Canada
28692 Madrid
Ethics committee country [1] 295586 0
Spain
Date submitted for ethics approval [1] 295586 0
28/07/2016
Approval date [1] 295586 0
13/01/2017
Ethics approval number [1] 295586 0
13/01/2017

Summary
Brief summary
Massage may produce, by the pressure done on tissue, a decrease in muscle stiffness, an increasing of blood flow by an increase of arteriolar pressure, as well as an increase muscle temperature due to rubbing. Depending on the techniques, we would expect an increase or decrease of neural excitability measured by Hoffman reflex (neurological mechanism); changes in parasympathetic activity measured by heart rate; blood pressure and heartbeat; and changes in hormone levels measured by cortisol levels following after a massage relaxation produced by the massage (physiological mechanisms).

It seems appropriate, to carry out a study to determine whether there is a significant improvement in patients who suffer from some type of skeletal muscle pathology and received a massotherapy treatment with the cream under study. Moreover, it seems clear that an analysis of the main factors affecting the purchase of massage creams should be performed, from a standpoint of general consumer and from the perspective of the therapist.
Trial website
Trial related presentations / publications
Public notes
The recruitment of the first participant was realized with the provisionally approved by the Ethics Comitee.

Contacts
Principal investigator
Name 67854 0
Dr Jesus Guodemar-Perez
Address 67854 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
Villanueva de la Canada
28692 Madrid
Country 67854 0
Spain
Phone 67854 0
+34 91 815 31 31
Fax 67854 0
Email 67854 0
[email protected]
Contact person for public queries
Name 67855 0
Jesus Guodemar-Perez
Address 67855 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
Villanueva de la Canada
28692 Madrid
Country 67855 0
Spain
Phone 67855 0
+34 91 815 31 31
Fax 67855 0
Email 67855 0
[email protected]
Contact person for scientific queries
Name 67856 0
Jesus Guodemar-Perez
Address 67856 0
Camilo Jose Cela University
C/ Castillo de Alarcon, 49
Urb. Villafranca del Castillo
Villanueva de la Canada
28692 Madrid
Country 67856 0
Spain
Phone 67856 0
+34 91 815 31 31
Fax 67856 0
Email 67856 0
[email protected]

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Results publications and other study-related documents

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