Myofascial Trigger Point PainvibraMTrPNCT02393521
The Effect of Vibration Therapy Over Neck Myofascial Trigger Points
A study testing Shindo® vibration mattress in people with Myofascial Trigger Point Pain and Neck Pain, run by University of Valencia at 1 site in Spain.
Trial summary
The aim of this study was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Trigger Point Pain, Neck Pain
- What is being tested?
- Shindo® vibration mattress
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteSpain
- Study dates
- Aug 2014to Dec 2019
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- a score of ≥ 5/50 in Neck Disability Index
- active or latent myofascial trigger points in upper trapezius or levator scapulae muscles
Who cannot join
- previous cervical spine surgery
- cervical radiculopathy
- severe systemic disease
- fibromyalgia
- other widespread musculoskeletal pain syndromes
- patients being treated with medication or physiotherapy within the last 4 weeks
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Vibration Therapy on Pressure Pain Thresholds Over Neck Myofascial Trigger Points: a Randomized Controlled Study
The aim of this study was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized that patients receiving vibration therapy would report less perceived neck pain, disability and present higher PPTs after receiving vibration therapy when compared to a control no-treatment group.
Read the detailed description
Myofascial trigger points (MTrPs) are a common source of (regional) pain in patients presenting with musculoskeletal pain. Mechanical vibration has been suggested as a treatment for pain relief. In this study, the effects of vibration therapy on people with non-specific neck pain and MTrPs were investigated. Seventeen chronic non-specific neck pain patients were randomly assigned to a treatment (vibration group, n = 9) or control group (n = 8). Vibration group received 10 self-administered sessions of vibration therapy (45-50 Hz for 15 minutes with the subject laying in supine). Perceived neck pain and disability and pressure pain thresholds over MTrPs of the upper trapezius and levator scapulae bilateraly were measured at baseline and after the first, five and 10 treatment sessions.
- Conditions
- Myofascial Trigger Point Pain, Neck Pain
- Being tested
- Shindo® vibration mattress
- Keywords
- Vibration, Pressure Pain Threshold, Trigger Points, Neck Pain
- Medical subject headings
- Myofascial Pain Syndromes, Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shindo® vibration mattressDevice
Also called vibration therapy
vibration therapy was self-administered while the subject was laying in supine in a polyurethane mattress
| Study group | Role | What they receive |
|---|---|---|
| Vibration group | Experimental | Patients in the vibration therapy group received 10 self-administered sessions of vibration therapy (45-50 Hz), one session per day, remaining on their Shindo® vibration mattress at home in supine for 15 min. Receives: Device: Shindo® vibration mattress |
| Control group | No intervention | Subjects in the control group did not receive vibration therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pressure Pain Threshold (PPT)
Pain tolerance was measured at baseline (T0) and after the first (T1), five (T5) and 10 treatment sessions (T10).
Measured: 10 days
Secondary outcomes (1)
Neck Disability Index (NDI)
Perceived neck pain and disability were measured at baseline (T0) and after the first (T1), five (T5) and 10 treatment sessions (T10).
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startAug 2014
- Primary completionApr 2016
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Myofascial Trigger Point PainStudies of the same condition, open and under way.
- More trials run by University of ValenciaThe 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Valencia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lirios Dueñas, University of Valencia
- Investigators
- Sofía Pérez, PhD, Study director, University of Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393521
- Sponsor's protocol ID
- H1421077978677
- Acronym
- vibraMTrP
- Status last verified
- May 2022
- First submitted
- 22 Feb 2015
- Last updated
- 19 May 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.
PubMed 24596744
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Vibration Therapy on Pressure Pain Thresholds Over Neck Myofascial Trigger Points: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT02393521
- Acronym / sponsor ID
- vibraMTrP / H1421077978677
- Conditions
- Myofascial Trigger Point Pain, Neck Pain
- Keywords
- Vibration, Pressure Pain Threshold, Trigger Points, Neck Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of ValenciaUniversity, hospital or other
- Study start
- Aug 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 19 Mar 2015 (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 aim of this study was to investigate the efficacy of a self-administered vibration therapy treatment on neck pain, disability and pressure pain thresholds in patients with non-specific neck pain and myofascial trigger points (MTrPs). The investigators hypothesized that patients receiving vibration therapy would report less perceived neck pain, disability and present higher PPTs after receiving vibration therapy when compared to a control no-treatment group.
Detailed description
Myofascial trigger points (MTrPs) are a common source of (regional) pain in patients presenting with musculoskeletal pain. Mechanical vibration has been suggested as a treatment for pain relief. In this study, the effects of vibration therapy on people with non-specific neck pain and MTrPs were investigated. Seventeen chronic non-specific neck pain patients were randomly assigned to a treatment (vibration group, n = 9) or control group (n = 8). Vibration group received 10 self-administered sessions of vibration therapy (45-50 Hz for 15 minutes with the subject laying in supine). Perceived neck pain and disability and pressure pain thresholds over MTrPs of the upper trapezius and levator scapulae bilateraly were measured at baseline and after the first, five and 10 treatment sessions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vibration group | Experimental | Device: Shindo® vibration mattressPatients in the vibration therapy group received 10 self-administered sessions of vibration therapy (45-50 Hz), one session per day, remaining on their Shindo® vibration mattress at home in supine for 15 min. |
| Control group | No intervention | –Subjects in the control group did not receive vibration therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- a score of ≥ 5/50 in Neck Disability Index
- active or latent myofascial trigger points in upper trapezius or levator scapulae muscles
Key exclusion criteria (6 listed)
- previous cervical spine surgery
- cervical radiculopathy
- severe systemic disease
- fibromyalgia
- other widespread musculoskeletal pain syndromes
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 |
|---|---|---|
| Shindo® vibration mattressAlso: vibration therapyvibration therapy was self-administered while the subject was laying in supine in a polyurethane mattress | Device | Vibration group |
Primary outcome
Pressure Pain Threshold (PPT)
Time frame: 10 days
Pain tolerance was measured at baseline (T0) and after the first (T1), five (T5) and 10 treatment sessions (T10).
1 secondary outcome
Neck Disability Index (NDI)
Time frame: 10 days
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 19 May 2022.
- Results publication: PubMed 24596744Imtiyaz S, Veqar Z, Shareef MY. To Compare the Effect of Vibration Therapy and Massage in Prevention of Delayed Onset Muscle Soreness (DOMS). J Clin Diagn Res. 2014 Jan;8(1):133-6. doi: 10.7860/JCDR/2014/7294.3971. Epub 2014 Jan 12.
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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.
Sofía Pérez, PhD study director
University of Valencia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shindo® vibration mattress in people with Myofascial Trigger Point Pain and Neck Pain, run by University of Valencia 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 2 inclusion and 6 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 19 May 2022. 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?
Pressure Pain Threshold (PPT) (time frame: 10 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02393521, which also lists 1 linked publication.
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 19 May 2022.