INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED
ECA_TMI
THE INMEDIATE EFFECTS OF RICHELLI'S PAINRELIEVER ON UPPER TRAPEZIUS MYOFASCIAL TRIGGER POINT IN PATIENTS SUFFERING FROM NECK PAIN: A RANDOMIZED CONTROLLED TRIAL
1 other identifier
interventional
30
1 country
1
Brief Summary
This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
October 31, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2017
CompletedMarch 31, 2017
March 1, 2017
Same day
October 31, 2016
March 30, 2017
Conditions
Outcome Measures
Primary Outcomes (3)
• Pain as measured by VAS
The Visual Analogue Scale (VAS) was designed to allow a subjective assessment of pain. A VAS is usually a horizontal line of 10 cm. with perpendicular lines at the ends, which are defined as the extreme limits of the painful experience. Previous studies have shown that the VAS has adequate psychometric properties, including test-retest reliability (r = 0.78) and convergent validity with other measures of pain such as the McGill Pain Questionnaire (r = 0.49 to 0.65) (Sriwatanakul K ., 1983).
10 minutes
• Stiffness of the right upper trapezius myofascial trigger point measured by MyoptronPRO.
Stiffness characteristics will be measured using a handheld MyotonPRO device (MyotonPRO, Myoton Ltd, Estonia). MyotonPRO has shown high levels of reliability in a session or between sessions both by the same operator (intra-rater) and between different operators (inter-rater), both in young subjects and elderly (Aird et al., 2012) (Mullix et al., 2012). Stiffness (N/m) will be calculated by software of MyotonPRO (Vain, 1994, 1995). Stiffness is the ability of tissue to restore it shape after removing of external force acting on the muscle.
10 minutes
• Stiffness (Hz) of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
Sono-myoelastography uses an external vibration source with a frequency less than 1000 Hz in conjunction with Doppler techniques to identify localized regions of increased tissue stiffness (Muro-Culebras, 2013). In this study vibrations will be produced in the right upper trapezius muscle using an external massage vibrator (Model NC70209, North Coast Medical, Gilroy, CA, USA) modified with a flat and elongated applicator (with an application area of 1 x 4 cm). This vibration source will be placed approximately 2-3 cm away from each of the points marked as ''positive'' in the clinical examination and induce vibrations of about 92 Hz. By use of the power Doppler technique, the sono-myoelastography images will be collected while applying vibrations.
10 minutes
Secondary Outcomes (5)
pain threshold pressure PPT
10 minutes
• Grip strength as measured by a Dynamometer
10 minutes
•PRO Spine Functional Index SFI-Sp
10 minutes
•PRO Neck Disability Index-Sp
10 minutes
• Blood flow of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
10 minutes
Other Outcomes (3)
• Tone of the right upper trapezius myofascial trigger point measured by MyoptronPRO
10 minutes
• Elasticity of the right upper trapezius myofascial trigger point measured by MyoptronPRO
10 minutes
• Morphology of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
10 minutes
Study Arms (2)
Instrumented massage
EXPERIMENTALManual massage
ACTIVE COMPARATORInterventions
The first group will receive a 20 min session of instrumented massage on back and neck areas. Subjects will be in prone position and physical therapist will applied instrumental massage in a protocolised way from low back until neck muscles, both in left and right side of the body.
The second group will receive a 20 min session of manual massage on back and neck areas. Subjects will be in prone position and physical therapist will applied manual massage in a protocolised way from low back until neck muscles, both in left and right side of the body.
Eligibility Criteria
You may qualify if:
- To be of legal age.
- To understand correctly Spanish.
- To show their approval by signing the informed consent.
- Suffering from mechanical neck pain
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Antonio Cuesta-Vargas
Málaga, Malaga, 29010, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Research PhD
Study Record Dates
First Submitted
October 31, 2016
First Posted
November 2, 2016
Study Start
January 1, 2016
Primary Completion
January 1, 2016
Study Completion
March 1, 2017
Last Updated
March 31, 2017
Record last verified: 2017-03
Data Sharing
- IPD Sharing
- Will share