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Trial record 51 of 97 for:    fibromyalgia | Open Studies | Interventional Studies

Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified May 2013 by University of Sao Paulo
Sponsor:
Information provided by (Responsible Party):
Rinaldo Roberto de Jesus Guirro, University of Sao Paulo
ClinicalTrials.gov Identifier:
NCT01869283
First received: May 27, 2013
Last updated: May 30, 2013
Last verified: May 2013
  Purpose
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%.

Condition Intervention
Neck Pain
Myofascial Pain Syndrome
Other: Kinesiotherapy
Other: Ultrasound
Other: Diadynamic currents

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by University of Sao Paulo:

Primary Outcome Measures:
  • Pain [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Cervical range of motion [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.

  • Skin temperature [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Through of thermograph will be evaluated skin temperature on myofascial trigger points.

  • Muscle activity [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.


Estimated Enrollment: 80
Study Start Date: May 2013
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other: Kinesiotherapy
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.
Other: Kinesiotherapy Other: Ultrasound
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.
Other: Kinesiotherapy Other: Diadynamic currents
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.

  Eligibility

Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01869283

Contacts
Contact: Rinaldo Guirro, PhD +551636024584 rguirro@fmrp.usp.br

Locations
Brazil
University of Sao Paulo Not yet recruiting
Ribeirão Preto, São Paulo, Brazil, 14049-900
Contact: Rinaldo Guirro, PhD    +551636024584    rguirro@fmrp.usp.br   
Sponsors and Collaborators
University of Sao Paulo
Investigators
Principal Investigator: Rinaldo Guirro, PhD University of São Paulo
  More Information

Additional Information:
Responsible Party: Rinaldo Roberto de Jesus Guirro, Professor, PT, PhD, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT01869283     History of Changes
Other Study ID Numbers: U1111-1143-4456 
Study First Received: May 27, 2013
Last Updated: May 30, 2013
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by University of Sao Paulo:
Physical Therapy Modalities
Myofascial Pain Syndromes
Skeletal Muscle

Additional relevant MeSH terms:
Myofascial Pain Syndromes
Fibromyalgia
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases

ClinicalTrials.gov processed this record on December 06, 2016