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

Primary Purpose

Neck Pain, Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Kinesiotherapy
Ultrasound
Diadynamic currents
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Physical Therapy Modalities, Myofascial Pain Syndromes, Skeletal Muscle

Eligibility Criteria

18 Years - 59 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Sao Paulo

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

No Intervention

Arm Label

Kinesiotherapy group

kinesiotherapy + static ultrasound group

kinesiotherapy + diadynamic currents group

Control group

Arm Description

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.

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.

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Cervical range of motion
Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.
Skin temperature
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
Muscle activity
Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.

Full Information

First Posted
May 27, 2013
Last Updated
May 30, 2013
Sponsor
University of Sao Paulo
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1. Study Identification

Unique Protocol Identification Number
NCT01869283
Brief Title
Effectiveness of Physical Therapy Treatments of Myofascial Trigger Points in Subjects With Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2013
Overall Recruitment Status
Unknown status
Study Start Date
May 2013 (undefined)
Primary Completion Date
June 2016 (Anticipated)
Study Completion Date
June 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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%.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Myofascial Pain Syndrome
Keywords
Physical Therapy Modalities, Myofascial Pain Syndromes, Skeletal Muscle

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotherapy group
Arm Type
Experimental
Arm Description
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.
Arm Title
kinesiotherapy + static ultrasound group
Arm Type
Experimental
Arm Description
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.
Arm Title
kinesiotherapy + diadynamic currents group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Kinesiotherapy
Intervention Type
Other
Intervention Name(s)
Ultrasound
Intervention Type
Other
Intervention Name(s)
Diadynamic currents
Primary Outcome Measure Information:
Title
Pain
Description
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).
Time Frame
3 years
Secondary Outcome Measure Information:
Title
Cervical range of motion
Description
Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.
Time Frame
3 years
Title
Skin temperature
Description
Through of thermograph will be evaluated skin temperature on myofascial trigger points.
Time Frame
3 years
Title
Muscle activity
Description
Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
59 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rinaldo Guirro, PhD
Phone
+551636024584
Email
rguirro@fmrp.usp.br
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rinaldo Guirro, PhD
Organizational Affiliation
University of São Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo
City
Ribeirão Preto
State/Province
São Paulo
ZIP/Postal Code
14049-900
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rinaldo Guirro, PhD
Phone
+551636024584
Email
rguirro@fmrp.usp.br

12. IPD Sharing Statement

Links:
URL
http://www.fmrp.usp.br
Description
Related Info

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

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