Clinical trial NCT03563079: Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) on Pain and Disability in Individuals With Non-specific Chronic Neck Pain.
Official title: Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) on Pain and Disability in Individuals With Non-specific Chronic Neck Pain: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Neck Pain
Myofascial Pain Syndrome
Keywords: Handling, Musculoskeletal
Tissue, Subcutaneous
Myofascial Release
Instrument-Mobilized Soft Tissue Mobilization
Lead sponsor: Federal University of Health Science of Porto Alegre
Sponsor class: OTHER
First posted: 2018-06-20
Enrollment: 6
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized clinical trial
Primary purpose: TREATMENT

Brief summary: INTRODUCTION: Cervical pain is a very common clinical condition in the world population, and can affect 70% of people at some point in life. Many of these conditions arise from musculoskeletal disorders, which may be caused by myofascial dysfunctions. Instrument-assisted soft tissue mobilization (IASTM) may be an important therapeutic tool as a means of treatment under these conditions. PURPOSE: To verify the effect of instrument-assisted soft tissue mobilization (IASTM) on pain, disability and range of motion (ROM) in individuals with non-specific chronic neck pain. DESIGN: Randomized Clinical Trial. METHODS: The sample will consist of 46 volunteers with non-specific chronic neck pain of both sexes, aged between 18 and 60 years, who presented pain for at least 12 weeks, without irradiation to the upper limbs distally to the shoulders. Of these, those that are not excluded, will be allocated randomly in one of the two groups present: Experimental Group (GE) - IASTM in the neck and Control Group (CG) - Manual myofascial release in the neck region. A blinded evaluator will be assigned to conduct the evaluation process for both groups. DESPECTS: The outcomes will be neck pain, neck disability and range of motion of the neck.

Detailed description: * To verify the effect of instrument-assisted soft tissue mobilization (IASTM) on pain, disability and ROM in individuals with non-specific chronic neck pain.
* Characterization of individuals with chronic nonspecific neck pain. To describe and compare, at the pre-intervention, post-intervention moments in a 3-week follow-up period, the intensity of neck pain using the numerical pain scale (NPS); the self - perception of disability using the Neck Disability Index (NDI) and range of motion (ROM) of the neck - flexion, extension, rotations and right and left slopes through a pendulum flexometer.
* Randomized unicentric clinical trial of longitudinal cut according to the standardization proposed by the Consolidated Standards of Reporting Trials - CONSORT statement
* The sample will be composed of 46 volunteers with chronic nonspecific neck pain.
* The subjects will be recruited through digital ads in the main social networks, as well as coming from the Physiotherapy service in a clinic in the city of Viamão / RS. An online form will be completed by the interested parties, which will include the eligibility criteria for participation in the study. Only the subjects that follow the criteria will be allocated to carry out the study.

Eligibility criteria: Inclusion Criteria:

* people presenting as main complaint chronic neck pain, manifested for at least twelve weeks, without irradiation to the upper limbs distally to the shoulders.
* presenting scales scores (NSP) above 3 and NDI above 30%.

Exclusion Criteria:

* Individuals who are positive in the Spurling test, indicating Cervical Radiculopathy,
* Some severe clinical condition (such as fracture, neoplasia or systemic diseases); --
* history of previous surgery in the neck or thoracic spine;
* injury of whiplash trauma in the six months prior to evaluation;
* diagnosis of cervical stenosis;
* diagnosis of myelopathy;
* pregnancy;
* signs and symptoms of moderate to severe temporomandibular dysfunction,
* neck hematoma,
* neck scarring,
* severe osteoporosis,
* open lesions or recent neck fractures,
* generalized infections,
* coagulation disorders,
* acute inflammatory conditions,
* fever.
* Also excluded are patients who have undergone physical therapy or massage up to one month prior to the evaluation.

Primary outcomes:
measure: Evaluation of pain
timeFrame: assessment at baseline and its change in 1-week and 3-month follow-up
measure: Disability of the neck
timeFrame: assessment at baseline and its change in 1-week and 3-month follow-up
measure: Range of motion
timeFrame: assessment at baseline and its change in 1-week and 3-month follow-up
Secondary outcomes:
measure: characterization of the sample
timeFrame: baseline
Other outcomes:
Locations:
city: Porto Alegre
country: Brazil
facility: Federal university of health sciences of porto alegre
state: Rio Grande Do Sul
city: Porto Alegre
country: Brazil
facility: Universidade Federal de Ciências da Saúde de Porto Alegre
state: RS
Study officials:
References: