NCT01869283

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%.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2013

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2013

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

May 27, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 5, 2013

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

June 5, 2013

Status Verified

May 1, 2013

Enrollment Period

3.1 years

First QC Date

May 27, 2013

Last Update Submit

May 30, 2013

Conditions

Keywords

Physical Therapy ModalitiesMyofascial Pain SyndromesSkeletal Muscle

Outcome Measures

Primary Outcomes (1)

  • 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).

    3 years

Secondary Outcomes (3)

  • Cervical range of motion

    3 years

  • Skin temperature

    3 years

  • Muscle activity

    3 years

Study Arms (4)

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.

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.

Other: KinesiotherapyOther: 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.

Other: KinesiotherapyOther: 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.

Interventions

Kinesiotherapy groupkinesiotherapy + diadynamic currents groupkinesiotherapy + static ultrasound group
kinesiotherapy + static ultrasound group
kinesiotherapy + diadynamic currents group

Eligibility Criteria

Age18 Years - 59 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • neck pain for more than 90 days
  • aged 18 to 59 years
  • presence of trigger points in the upper trapezius muscle

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Sao Paulo

Ribeirão Preto, São Paulo, 14049-900, Brazil

Location

Related Links

MeSH Terms

Conditions

Neck PainMyofascial Pain Syndromes

Interventions

High-Energy Shock Waves

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical Phenomena

Study Officials

  • Rinaldo Guirro, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rinaldo Guirro, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PT, PhD

Study Record Dates

First Submitted

May 27, 2013

First Posted

June 5, 2013

Study Start

May 1, 2013

Primary Completion

June 1, 2016

Study Completion

June 1, 2017

Last Updated

June 5, 2013

Record last verified: 2013-05

Locations