Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE May 25, 2018
First Posted Date  ICMJE June 20, 2018
Last Update Posted Date June 21, 2018
Actual Study Start Date  ICMJE April 30, 2018
Estimated Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
  • 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.
  • 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.
  • Range of motion [ Time Frame: assessment at baseline and its change in 1-week and 3-month follow-up ]
    For measurement, an angular flexometer
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 8, 2018)
characterization of the sample [ Time Frame: baseline ]
quiz
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) on Pain and Disability in Individuals With Non-specific Chronic Neck Pain.
Official Title  ICMJE Effects of Instrument-assisted Soft Tissue Mobilization (IASTM) on Pain and Disability in Individuals With Non-specific Chronic Neck Pain: A Randomized Clinical Trial
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Neck Pain
  • Myofascial Pain Syndrome
Intervention  ICMJE
  • Other: Instrument Assisted Soft Tissue Mobilization
    Soft Tissue Mobilization
    Other Name: IASTM
  • Other: Manual Myofascial Release
    Myofascial Release Technique
Study Arms  ICMJE
  • 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.
    Intervention: Other: Instrument Assisted Soft Tissue Mobilization
  • 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.
    Intervention: Other: Manual Myofascial Release
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 8, 2018)
6
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 10, 2019
Estimated Primary Completion Date April 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03563079
Other Study ID Numbers  ICMJE FAraujo
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Francisco Xavier de Araujo, Pt, Federal University of Health Science of Porto Alegre
Study Sponsor  ICMJE Federal University of Health Science of Porto Alegre
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Federal University of Health Science of Porto Alegre
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP