Neck PainECA_TMINCT02953236
INSTRUMENTED-MANUAL PHYSIOTHERAPY VERSUS NONINSTRUMENTED
A study testing Instrumented massage and Manual massage in people with Neck Pain, run by University of Malaga at 1 site in Spain.
Trial summary
This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Neck Pain
- What is being tested?
- Instrumented massage and Manual massage
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2016to Mar 2017
- 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 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- • To be of legal age.
- To understand correctly Spanish.
- To show their approval by signing the informed consent.
- Suffering from mechanical neck pain
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: THE INMEDIATE EFFECTS OF RICHELLI'S PAINRELIEVER ON UPPER TRAPEZIUS MYOFASCIAL TRIGGER POINT IN PATIENTS SUFFERING FROM NECK PAIN: A RANDOMIZED CONTROLLED TRIAL
This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Read the detailed description
Background: There are several therapies currently used to treat myofascial trigger points, including conservative and invasive techniques. It has been shown that conservative techniques including therapeutic massage, stretching, transcutaneal electrical nerve stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied treatments for myofascial pain syndrome, but no single strategy has proved to be universally successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back pain, and only one study (case report) on myofascial trigger points. This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Methods/Design: The study includes 31 volunteers with myofascial trigger points on right trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS, algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was measured. Subjects were randomly allocated into one of two groups: Instrumented massage or Manual massage. The intervention consisted in a single 20 minutes session of massage on the back and neck by the same therapist, depending of the group, massage was applied manually or instrumented.
- Conditions
- Neck Pain
- Being tested
- Instrumented massage, Manual massage
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Instrumented massageProcedure or surgery
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.
Manual massageProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Instrumented massage | Experimental | Not described Receives: Procedure: Instrumented massage |
| Manual massage | Active comparator | Not described Receives: Procedure: Manual massage |
What is being measured
The primary outcome is the main question the study is designed to answer.
• 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).
Measured: 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.
Measured: 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.
Measured: 10 minutes
Secondary outcomes (5)
pain threshold pressure PPT
Measured: 10 minutes
• Grip strength as measured by a Dynamometer
This instrument will be used to measure grip strength of both physiotherapist upper limbs. The dynamometer has proven to be the safest [ICC = 0.98] and most valid [ICC = 0.99] method to measure grip strength of the hand. (Bellace JV, 2000).
Measured: 10 minutes
•PRO Spine Functional Index SFI-Sp
For this study we will use the Spanish version (SFI-Sp), since it has proven to be a valid and reliable measure of the spinal region result. This regional tool reflects the status and any change in the kinetic chain of the spine. This questionnaire has demonstrated high internal consistency (α = 0.85) and reliability (r = 0.96) (AI Cuesta-Vargas, 2014).
Measured: 10 minutes
•PRO Neck Disability Index-Sp
Neck Disability Index is the most widely used neck pain scale in the largest number of populations and has been validated most often against multiple measurements of function, pain, and clinical signs and symptoms. (Cleland et al., 2006). For this study we will use the Spanish version (NDI-Sp), since it has proven to be reliable (r = 0.98), valid, and sensitive to change. (Andrade et al., 2010).
Measured: 10 minutes
• Blood flow of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
Circulation will be studied using the Doppler technique, since it has been shown for other studies (Sikdar et al., 2009). The resistive index (RI) is determined in the ascending branch of the transverse cervical artery and in other arteries or arterioles that will be in the vicinity of points marked as ''positive'' in the clinical examination. The waveform of blood flow, based on Doppler flow, will be scored on a scale of 0-2 (Sikdar et al. 2009).
Measured: 10 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2016 (estimated)
- Study startJan 2016
- Primary completionJan 2016
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Antonio I Cuesta-Vargas, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02953236
- Sponsor's protocol ID
- 103-2015-H
- Acronym
- ECA_TMI
- Status last verified
- Mar 2017
- First submitted
- 31 Oct 2016
- Last updated
- 31 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- THE INMEDIATE EFFECTS OF RICHELLI'S PAINRELIEVER ON UPPER TRAPEZIUS MYOFASCIAL TRIGGER POINT IN PATIENTS SUFFERING FROM NECK PAIN: A RANDOMIZED CONTROLLED TRIAL
- ClinicalTrials.gov ID
- NCT02953236
- Acronym / sponsor ID
- ECA_TMI / 103-2015-H
- Conditions
- Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2016 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 2 Nov 2016 (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.
This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Detailed description
Background: There are several therapies currently used to treat myofascial trigger points, including conservative and invasive techniques. It has been shown that conservative techniques including therapeutic massage, stretching, transcutaneal electrical nerve stimulation, spray and stretch, cold laser treatment, and ultrasound are the most applied treatments for myofascial pain syndrome, but no single strategy has proved to be universally successful. Instrumented massage has shown clinical effectiveness on shoulder pain, low back pain, and only one study (case report) on myofascial trigger points. This study aimed to verify the mechanical and clinical effects of instrumented massage on myofascial trigger points of trapezius muscle in adult subjects.
Methods/Design: The study includes 31 volunteers with myofascial trigger points on right trapezius muscle. Clinical and patient data were obtained from questionnaires, VAS, algometry, sono-myoelastography and myotonometry. Also, physiotherapist grip strength was measured. Subjects were randomly allocated into one of two groups: Instrumented massage or Manual massage. The intervention consisted in a single 20 minutes session of massage on the back and neck by the same therapist, depending of the group, massage was applied manually or instrumented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Instrumented massage | Experimental | Procedure: Instrumented massage |
| Manual massage | Active comparator | Procedure: Manual massage |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- • To be of legal age.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Instrumented massageThe 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. | Procedure or surgery | Instrumented massage |
| Manual massageThe 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. | Procedure or surgery | Manual massage |
Primary outcome
• Pain as measured by VAS
Time frame: 10 minutes
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).
• Stiffness of the right upper trapezius myofascial trigger point measured by MyoptronPRO.
Time frame: 10 minutes
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.
• Stiffness (Hz) of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
Time frame: 10 minutes
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.
5 secondary outcomes
pain threshold pressure PPT
Time frame: 10 minutes
• Grip strength as measured by a Dynamometer
Time frame: 10 minutes
•PRO Spine Functional Index SFI-Sp
Time frame: 10 minutes
•PRO Neck Disability Index-Sp
Time frame: 10 minutes
• Blood flow of the right upper trapezius myofascial trigger point measured by sono-myoelastography.
Time frame: 10 minutes
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 31 Mar 2017.
- Individual participant dataSharing planned: Yes
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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 Instrumented massage and Manual massage in people with Neck Pain, run by University of Malaga at 1 site in Spain.
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 4 inclusion and 1 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 31 Mar 2017. 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 Spain. 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. 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?
• Pain as measured by VAS (time frame: 10 minutes). The study lists 3 primary outcomes in all. 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 31 Mar 2017.