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

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ClinicalTrials.gov Identifier: NCT03563079
Recruitment Status : Unknown
Verified June 2018 by Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre.
Recruitment status was:  Recruiting
First Posted : June 20, 2018
Last Update Posted : June 21, 2018
Sponsor:
Information provided by (Responsible Party):
Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre

Study Description
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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.

Condition or disease Intervention/treatment Phase
Neck Pain Myofascial Pain Syndrome Other: Instrument Assisted Soft Tissue Mobilization Other: Manual Myofascial Release Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomized clinical trial
Masking: Single (Outcomes Assessor)
Masking Description: Participants selected to participate in this research will be randomly drawn and randomly allocated using sealed opaque envelopes, and therefore included randomly in one of the two groups present in this study. A collaborative researcher blind to the groups will be assigned to conduct the pre- and post-intervention evaluation process of all individuals.
Primary Purpose: Treatment
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
Actual Study Start Date : April 30, 2018
Estimated Primary Completion Date : April 20, 2019
Estimated Study Completion Date : May 10, 2019

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Arms and Interventions
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Arm Intervention/treatment
Experimental: trial group
The treatment will be performed using two pieces of Instrument Assisted Soft Tissue Mobilization (IASTM) stainless steel in the neck, bilaterally, which comprise the following muscles: Upper Trapezius, Splenius, scalenes and Sternocleidomastoid. An established time of 3 minutes will be used in each region, using an angle of 30 to 60º with the instrument. As it is observed, through the instrument, regions of greater adhesion, the researcher will use most of this time to release this condition.
 Other: Instrument Assisted Soft Tissue Mobilization
Soft Tissue Mobilization
Other Name: IASTM
Active Comparator: group control
Treatment will be performed using manual Myofascial Release techniques. Release the upper Trapezius muscle bilaterally, sliding using roller with the dorsum of the fingers and ending with myofascial release. Sternocleidomastoid, sliding using roller with the dorsum of the fingers, ending with myofascial release. Afterwards the release of the scalenes muscles will be performed, with the fingers sliding and ending with the myofascial release. Soon afterwards techniques will be performed for the Splenius muscles, using finger slips and ending with posterior cervicothoracic release. The same time of 3 min will be used for the treatment bilaterally in each region.
 Other: Manual Myofascial Release
Myofascial Release Technique


Outcome Measures
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Primary Outcome Measures :
  1. Evaluation of pain [ Time Frame: assessment at baseline and its change in 1-week and 3-month follow-up ]
    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.

  2. Disability of the neck [ Time Frame: assessment at baseline and its change in 1-week and 3-month follow-up ]
    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.

  3. Range of motion [ Time Frame: assessment at baseline and its change in 1-week and 3-month follow-up ]
    For measurement, an angular flexometer


Secondary Outcome Measures :
  1. characterization of the sample [ Time Frame: baseline ]
    quiz


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03563079


Locations
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Brazil
Federal university of health sciences of porto alegre Recruiting
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
Contact: Raffaele C Greco    +5551992033035    cunhagreco@yahoo.com.br   
Principal Investigator: Raffaele C Greco         
Universidade Federal de Ciências da Saúde de Porto Alegre Recruiting
Porto Alegre, RS, Brazil, 90050-170
Contact: Francisco Araujo, Pt    +55 5192581467    franciscoxaraujo@gmail.com   
Principal Investigator: Francisco De Araujo, Pt         
Sponsors and Collaborators
Federal University of Health Science of Porto Alegre
More Information
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Responsible Party: Francisco Xavier de Araujo, Pt, Principal Investigator, Federal University of Health Science of Porto Alegre
ClinicalTrials.gov Identifier: NCT03563079    
Other Study ID Numbers: FAraujo
First Posted: June 20, 2018    Key Record Dates
Last Update Posted: June 21, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre:
Handling, Musculoskeletal
Tissue, Subcutaneous
Myofascial Release
Instrument-Mobilized Soft Tissue Mobilization
Additional relevant MeSH terms:
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Myofascial Pain Syndromes
Fibromyalgia
Neck Pain
Pain
Neurologic Manifestations
 Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases