Neck PainNCT01869283
Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain
A study testing Kinesiotherapy, Ultrasound and Diadynamic currents in people with Neck Pain and Myofascial Pain Syndrome, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle. Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of myofascial trigger points. Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Neck Pain, Myofascial Pain Syndrome
- What is being tested?
- Kinesiotherapy, Ultrasound and Diadynamic currents
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- May 2013to Jun 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- neck pain for more than 90 days
- aged 18 to 59 years
- presence of trigger points in the upper trapezius muscle
Who cannot join
- history of trauma to the neck
- surgery in the head, face or neck
- herniated cervical
- degenerative diseases of the spine
- systemic diseases
- underwent physical therapy in the last three months
Show all 10Show fewer
- analgesics, anti-inflammatories or muscle relaxants last week
- medical diagnosis of fibromyalgia
- body mass index (BMI) greater than 28 kg/m2
- signs and symptoms of depression
Trial locations and contacts
1 site in 1 country.
Brazil1 site
University of Sao Paulo
Ribeirão Preto, São Paulo, 14049-900
Rinaldo Guirro, PhD, +551636024584, rguirro@fmrp.usp.br
About this study
Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle. Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of myofascial trigger points. These are related to the sensory, motor and autonomic changes, being defined as palpable nodules located in the taut band of skeletal muscle. In this context, the focus on treatment modalities stands out in the literature, however, other resources commonly used in clinical practice still lack scientific evidence. Therefore, the aim of this project is to evaluate the effectiveness of physiotherapy resources in the treatment of myofascial trigger points in the trapezius muscle of patients with neck pain. For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18 and 59 years and bilateral myofascial trigger points in the upper trapezius will be randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2 (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents, n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of treatment, being realized the following evaluations: surface electromyography, infrared thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin impedance. For data analysis, normality test will used to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and thus considered two factors in the comparisons, time and group. Will adopt a significance level of 5%.
- Conditions
- Neck Pain, Myofascial Pain Syndrome
- Being tested
- Kinesiotherapy, Ultrasound, Diadynamic currents
- Keywords
- Physical Therapy Modalities, Myofascial Pain Syndromes, Skeletal Muscle
- Medical subject headings
- Neck Pain, Myofascial Pain Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotherapyOther
UltrasoundOther
Diadynamic currentsOther
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotherapy group | Experimental | The volunteer will be subjected to the following protocol: cervical traction, 3 sets of 1 minute, 30-second rest between sets; mobilization grade III postero-anterior on the spines processes of vertebrae C2 to C7, 10 oscillations for each vertebrae; myofascial release of the upper trapezius muscle, 3 sets of 1 minute for each side; static stretching of the upper trapezius muscle, 3 sets of 30 seconds, with an interval of 10 seconds between sets. Receives: Other: Kinesiotherapy |
| kinesiotherapy + static ultrasound group | Experimental | Same protocol group kinesiotherapy + ultrasound on the trigger points of the upper trapezius muscle in a static way, with 1 MHz, continuous dose of 1.5 W/cm2, for 1.5 minutes. Receives: Other: Kinesiotherapy; Other: Ultrasound |
| kinesiotherapy + diadynamic currents group | Experimental | Same protocol group kinesiotherapy + diadynamic currents, with negative electrode (7.0 x 7.0 cm) placed on the myofascial trigger point, while the positive electrode (7.0 x 7.0 cm) is placed between the shoulder blades. Will apply 4 minutes from the biphasic mode (DF) and 6-minute short period (CP), the first of which intesidade the sensory threshold and the second threshold motor, both bearable for the patient. Receives: Other: Kinesiotherapy; Other: Diadynamic currents |
| Control group | No intervention | The volunteers of this group will not be subjected to any form of treatment, was evaluated in three stages, as the other groups. It is noteworthy that, after the volunteer's participation, will be offered at the same physical therapy for myofascial pain. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Will be apply the following assessment tools: Neck Disability Index (assesses neck pain and disability), algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
Measured: 3 years
Secondary outcomes (3)
Cervical range of motion
Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.
Measured: 3 years
Skin temperature
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
Measured: 3 years
Muscle activity
Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2013 (estimated)
- Study startMay 2013
- Primary completionJun 2016 (estimated)
- Study completionJun 2017 (estimated)
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.
- More trials run by University of Sao PauloThe 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
- Investigators
- Rinaldo Guirro, PhD, Principal investigator, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01869283
- Sponsor's protocol ID
- U1111-1143-4456
- Status last verified
- May 2013
- First submitted
- 27 May 2013
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain
- ClinicalTrials.gov ID
- NCT01869283
- Acronym / sponsor ID
- U1111-1143-4456
- Conditions
- Neck Pain, Myofascial Pain Syndrome
- Keywords
- Physical Therapy Modalities, Myofascial Pain Syndromes, Skeletal Muscle
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Jun 2017 (estimated)
- First posted
- 5 Jun 2013 (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.
Neck pain is a prevalent musculoskeletal dysfunction. Studies point that individuals with chronic pain have metabolic, vascular and electromyographic changes in trapezius muscle. Moreover, a common clinical sign in this muscle in subjects with neck pain is the presence of myofascial trigger points. These are related to the sensory, motor and autonomic changes, being defined as palpable nodules located in the taut band of skeletal muscle. In this context, the focus on treatment modalities stands out in the literature, however, other resources commonly used in clinical practice still lack scientific evidence. Therefore, the aim of this project is to evaluate the effectiveness of physiotherapy resources in the treatment of myofascial trigger points in the trapezius muscle of patients with neck pain. For such, volunteers with neck pain for more than 90 days, of both genders, aged between 18 and 59 years and bilateral myofascial trigger points in the upper trapezius will be randomized into the following groups: group 1 (kinesiotherapy, n = 20), group 2 (kinesiotherapy + static ultrasound, n = 20), group 3 (kinesiotherapy + diadynamic currents, n = 20) and group 4 (untreated control, n = 20). Volunteers will undergo ten sessions of treatment, being realized the following evaluations: surface electromyography, infrared thermography, numerical scale of pain assessment, algometry, Neck Disability Index and skin impedance. For data analysis, normality test will used to verify the data distribution and consistent statistical test for the appropriate comparisons within and between groups, and thus considered two factors in the comparisons, time and group. Will adopt a significance level of 5%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Kinesiotherapy group | Experimental | Other: KinesiotherapyThe volunteer will be subjected to the following protocol: cervical traction, 3 sets of 1 minute, 30-second rest between sets; mobilization grade III postero-anterior on the spines processes of vertebrae C2 to C7, 10 oscillations for each vertebrae; myofascial release of the upper trapezius muscle, 3 sets of 1 minute for each side; static stretching of the upper trapezius muscle, 3 sets of 30 seconds, with an interval of 10 seconds between sets. |
| kinesiotherapy + static ultrasound group | Experimental | Other: Kinesiotherapy, Other: UltrasoundSame protocol group kinesiotherapy + ultrasound on the trigger points of the upper trapezius muscle in a static way, with 1 MHz, continuous dose of 1.5 W/cm2, for 1.5 minutes. |
| kinesiotherapy + diadynamic currents group | Experimental | Other: Kinesiotherapy, Other: Diadynamic currentsSame protocol group kinesiotherapy + diadynamic currents, with negative electrode (7.0 x 7.0 cm) placed on the myofascial trigger point, while the positive electrode (7.0 x 7.0 cm) is placed between the shoulder blades. Will apply 4 minutes from the biphasic mode (DF) and 6-minute short period (CP), the first of which intesidade the sensory threshold and the second threshold motor, both bearable for the patient. |
| Control group | No intervention | –The volunteers of this group will not be subjected to any form of treatment, was evaluated in three stages, as the other groups. It is noteworthy that, after the volunteer's participation, will be offered at the same physical therapy for myofascial pain. |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- neck pain for more than 90 days
- aged 18 to 59 years
- presence of trigger points in the upper trapezius muscle
Key exclusion criteria (10 listed)
- history of trauma to the neck
- surgery in the head, face or neck
- herniated cervical
- degenerative diseases of the spine
- systemic diseases
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 |
|---|---|---|
| Kinesiotherapy | Other | Kinesiotherapy group, kinesiotherapy + diadynamic currents group, kinesiotherapy + static ultrasound group |
| Ultrasound | Other | kinesiotherapy + static ultrasound group |
| Diadynamic currents | Other | kinesiotherapy + diadynamic currents group |
Primary outcome
Pain
Time frame: 3 years
Will be apply the following assessment tools: Neck Disability Index (assesses neck pain and disability), algometry (evaluates pressure pain threshold), and numerical scale of pain assessment (assesses pain intensity).
3 secondary outcomes
Cervical range of motion
Time frame: 3 years
Skin temperature
Time frame: 3 years
Muscle activity
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jun 2013.
- Related InfoLink provided by the sponsor.
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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.
Rinaldo Guirro, PhD principal investigator
University of Sao Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotherapy, Ultrasound and Diadynamic currents in people with Neck Pain and Myofascial Pain Syndrome, run by University of Sao Paulo at 1 site in Brazil.
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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 5 Jun 2013. 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 Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rinaldo Guirro, PhD (+551636024584, rguirro@fmrp.usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 3 years). 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 5 Jun 2013.