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

Neck Pain Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01869283
• Other study ID #: U1111-1143-4456
• Status: Not yet recruiting
• Phase: N/A
• First received: May 27, 2013
• Last updated: May 30, 2013
• Start date: May 2013
• Est. completion date: June 2017

Study information

• Verified date: May 2013
• Source: University of Sao Paulo
• Contact: Rinaldo Guirro, PhD
• Phone: +551636024584
• Email: rguirro[@]fmrp.usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical 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. 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%.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: June 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 59 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndrome
• Myofascial Pain Syndromes
• Neck Pain

Intervention

Other:
• Kinesiotherapy

• Ultrasound

• Diadynamic currents

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Ribeirão Preto	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Cervical range of motion	Through a fleximeter will be evaluated movements of flexion, extension, rotation and inclination of the neck.	3 years	No
Secondary	Skin temperature	Through of thermograph will be evaluated skin temperature on myofascial trigger points.	3 years	No
Secondary	Muscle activity	Through surface electromyography will be evaluated the electrical activity of the upper trapezius muscle.	3 years	No

External Links

•   Link