Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) on Pain and Disability in Individuals With Non-specific Chronic Neck Pain.

Neck Pain Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03563079
• Other study ID #: FAraujo
• Status: Recruiting
• Phase: N/A
• Start date: April 30, 2018
• Est. completion date: May 10, 2019

Study information

• Verified date: June 2018
• Source: Federal University of Health Science of Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 6
• Est. completion date: May 10, 2019
• Est. primary completion date: April 20, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Other:
• Instrument Assisted Soft Tissue Mobilization
Soft Tissue Mobilization
• Manual Myofascial Release
Myofascial Release Technique

Locations

Country	Name	City	State
Brazil	Federal university of health sciences of porto alegre	Porto Alegre	Rio Grande Do Sul
Brazil	Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	RS

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Health Science of Porto Alegre

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of pain	the numerical scale of pain will be used. The Numerical Scale consists of a ruler divided into equal parts, numbered successively from 0 to 10. The study participant is meant to make the equivalence between the intensity of his pain and a numerical classification, where 0 corresponds to the classification "No Pain" and 10 to the classification "Maximum Pain" (pain of maximum intensity imaginable), that is, the higher the number the worse the score.	assessment at baseline and its change in 1-week and 3-month follow-up
Primary	Disability of the neck	Neck disability index. The Neck Disability Index is used to assess the functional capacity of the neck. Is composed of 10 questions regarding activities and pain. Items are organized by type of activity and followed by six different statements expressing progressive functional capacity levels. The NDI score consists of the sum of the points, from 0 to 5 of each of the 10 questions, totaling a maximum of 50 points. O value can be expressed as a percentage, on a scale of 0% (no disability) to 100% (complete disability). The score total is divided by the number of questions answered multiplied by number 5. The higher the score, the greater the patient's disability.	assessment at baseline and its change in 1-week and 3-month follow-up
Primary	Range of motion	For measurement, an angular flexometer	assessment at baseline and its change in 1-week and 3-month follow-up
Secondary	characterization of the sample	quiz	baseline