- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01869283
Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain
May 30, 2013 updated by: Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
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 Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Rinaldo Guirro, PhD
- Phone Number: +551636024584
- Email: rguirro@fmrp.usp.br
Study Locations
-
-
São Paulo
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Ribeirão Preto, São Paulo, Brazil, 14049-900
- University of Sao Paulo
-
Contact:
- Rinaldo Guirro, PhD
- Phone Number: +551636024584
- Email: rguirro@fmrp.usp.br
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- neck pain for more than 90 days
- aged 18 to 59 years
- presence of trigger points in the upper trapezius muscle
Exclusion Criteria:
- 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
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Kinesiotherapy group
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.
|
|
Experimental: kinesiotherapy + static ultrasound group
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.
|
|
Experimental: kinesiotherapy + diadynamic currents group
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.
|
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No Intervention: Control group
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 the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cervical range of motion
Time Frame: 3 years
|
Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.
|
3 years
|
Skin temperature
Time Frame: 3 years
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Through of thermograph will be evaluated skin temperature on myofascial trigger points.
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3 years
|
Muscle activity
Time Frame: 3 years
|
Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.
|
3 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rinaldo Guirro, PhD, University of Sao Paulo
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2013
Primary Completion (Anticipated)
June 1, 2016
Study Completion (Anticipated)
June 1, 2017
Study Registration Dates
First Submitted
May 27, 2013
First Submitted That Met QC Criteria
May 30, 2013
First Posted (Estimate)
June 5, 2013
Study Record Updates
Last Update Posted (Estimate)
June 5, 2013
Last Update Submitted That Met QC Criteria
May 30, 2013
Last Verified
May 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1143-4456
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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