Myofascial Trigger Point PainNCT02219386
Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain
A study testing Group 1. Deep dry needling and group 2. Passive analitical stretch (performed in both groups) in people with Myofascial Trigger Point Pain, run by University of Alcala at 1 site in Spain.
Trial summary
Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Trigger Point Pain
- What is being tested?
- Group 1. Deep dry needling and group 2. Passive analitical stretch (performed in both groups)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2011to Jan 2014
- 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
- over 18
- present myofascial trigger points in trapezius muscle
Who cannot join
- to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)
- to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain. Randomised, Single Blinded Clinical Trial
Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients
Read the detailed description
EVALUATION:
A blind assesor does a complete evaluation of the patients to determine if they take part of the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in Newtons) are performed. In this evaluation inclusion criteria is checked too.
INTERVENTION:
-TREATMENT GROUP(Deep dry needling group (DDN)):
An experienced physical therapist performed this treatment. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP.
After that, the stretch is performed
- Passive stretch of the trapezius muscle (both groups)
Another experienced physical therapist, after taking part of training-sesions to do the same stretch as in DDN group, performed the stretch.Participants in this group received the same stretch as patients in treatment group.
- Conditions
- Myofascial Trigger Point Pain
- Being tested
- Group 1. Deep dry needling, group 2. Passive analitical stretch (performed in both groups)
- Keywords
- Myofascial pain syndromes,physiotherapy,muscle stretching exercises,neck pain,dry needling
- Medical subject headings
- Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1. Deep dry needlingOther
Deep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle.
group 2. Passive analitical stretch (performed in both groups)Other
Also called only the same stretch as performed in deep dry needling group.
| Study group | Role | What they receive |
|---|---|---|
| Deep dry needling | Active comparator | The group of DDN receive this treatment and stretch Receives: Other: Group 1. Deep dry needling |
| muscle stretch | Other | The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times Receives: Other: Group 1. Deep dry needling; Other: group 2. Passive analitical stretch (performed in both groups) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks)
pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
Measured: pretreatment, postreatment and follow-up(15 days)
Secondary outcomes (1)
Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks)
pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
Measured: Pretreatment, post treatment and follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2014 (estimated)
- Study startJan 2011
- Primary completionDec 2013
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofascial Trigger Point 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
- Single blind
- Who is masked
- Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alcala
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ester Cerezo-Téllez, University of Alcala
- Investigators
- Ester Cerezo-Téllez, PT, Principal investigator, Alcalá University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02219386
- Sponsor's protocol ID
- 44/11Comision of investigation
- Status last verified
- Aug 2014
- First submitted
- 8 Aug 2014
- Last updated
- 3 Sep 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dry Needling of the Trapezius Muscle in Office Workers With Neck Pain. Randomised, Single Blinded Clinical Trial
- ClinicalTrials.gov ID
- NCT02219386
- Acronym / sponsor ID
- 44/11Comision of investigation
- Conditions
- Myofascial Trigger Point Pain
- Keywords
- Myofascial pain syndromes,physiotherapy,muscle stretching exercises,neck pain,dry needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of AlcalaUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 Aug 2014 (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.
Deep dry needling of active myofascial trigger points of trapezius muscle is effective in the dimminution of pain of patients
Detailed description
EVALUATION:
A blind assesor does a complete evaluation of the patients to determine if they take part of the study. An assesment of pain (by visual analogue scale), Pain pressure theshold (kg/cm2 by algometry, Range of motion (CROM goniometer in degrees) and strength (digital dinamometry in Newtons) are performed. In this evaluation inclusion criteria is checked too.
INTERVENTION:
-TREATMENT GROUP(Deep dry needling group (DDN)):
An experienced physical therapist performed this treatment. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle with guided tube. ). In the case of upper trapezius active MTrPs, DDN was performed in the prone position. For medium and lower trapezius muscle MTrPs, DDN was performed in a side-lying position as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP.
After that, the stretch is performed
- Passive stretch of the trapezius muscle (both groups)
Another experienced physical therapist, after taking part of training-sesions to do the same stretch as in DDN group, performed the stretch.Participants in this group received the same stretch as patients in treatment group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Deep dry needling | Active comparator | Other: Group 1. Deep dry needlingThe group of DDN receive this treatment and stretch |
| muscle stretch | Other | Other: Group 1. Deep dry needling, Other: group 2. Passive analitical stretch (performed in both groups)The stretch applied was as described by Simons et al. (Simons et al., 1999). During the stretch the physiotherapist took up the slack, avoiding pain elicitation, maintaining the tension for four seconds and releasing the tension for eight seconds; this cycle was repeated three times |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- over 18
- present myofascial trigger points in trapezius muscle
Key exclusion criteria (2 listed)
- to be under anti-inflammatory, analgesic, anticoagulant, muscle relaxant or antidepressant medication at the start of the study or one week before it (Simons, 2004)
- to suffer from fibromyalgia syndrome, or to have any contraindication to conservative or invasive physiotherapy (infection, fever, hypothyroidism, fear of needles, wounds in the area of the puncture, metal allergy, cancer, systemic disease) (Baldry, 2005).
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 |
|---|---|---|
| Group 1. Deep dry needlingDeep dry needling and stretch. The intervention included DDN of every active MTrP found in the trapezius muscle using a 4 cm x 0.32 mm acupuncture needle as described by Simons et al. (Simons et al., 1999). Once the needle was inserted into the MTrP previously marked by the blinded assessor, local twitch responses (LTRs) were obtained by using Hong's fast-in and fast-out technique, which involves rapid movements of the needle in and out of the MTrP. After four LTRs, the needle was withdrawn and the area was disinfected with alcohol again (Simons et al., 1999). Then, passive stretch was performed on the trapezius muscle. | Other | Deep dry needling, muscle stretch |
| group 2. Passive analitical stretch (performed in both groups)Also: only the same stretch as performed in deep dry needling group. | Other | muscle stretch |
Primary outcome
Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks)
Time frame: pretreatment, postreatment and follow-up(15 days)
pretreatment = at baseline; post-treatment= after 5 physical therapy sessions, 3 weeks after baseline; follow-up= 15 days after last intervention.
1 secondary outcome
Pain Pressure Threshold (PPT. Participants were followed for the duration of the intervention, an average of 6 weeks)
Time frame: Pretreatment, post treatment and follow-up.
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 3 Sep 2014.
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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.
Ester Cerezo-Téllez, PT principal investigator
Alcalá University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group 1. Deep dry needling and group 2. Passive analitical stretch (performed in both groups) in people with Myofascial Trigger Point Pain, run by University of Alcala 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 2 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 3 Sep 2014. 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?
Subjective Pain scored by Visual Analogue Scale (VAS.Participants were followed for the duration of the intervention, an average of 6 weeks) (time frame: pretreatment, postreatment and follow-up(15 days)). 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 3 Sep 2014.