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

Primary Purpose

Neck Pain, Myofascial Pain Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Instrument Assisted Soft Tissue Mobilization
Manual Myofascial Release
Sponsored by
Federal University of Health Science of Porto Alegre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Handling, Musculoskeletal, Tissue, Subcutaneous, Myofascial Release, Instrument-Mobilized Soft Tissue Mobilization

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Federal university of health sciences of porto alegreRecruiting
  • Universidade Federal de Ciências da Saúde de Porto AlegreRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

trial group

group control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.
Range of motion
For measurement, an angular flexometer

Secondary Outcome Measures

characterization of the sample
quiz

Full Information

First Posted
May 25, 2018
Last Updated
June 19, 2018
Sponsor
Federal University of Health Science of Porto Alegre
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1. Study Identification

Unique Protocol Identification Number
NCT03563079
Brief Title
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

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2018 (Actual)
Primary Completion Date
April 20, 2019 (Anticipated)
Study Completion Date
May 10, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Health Science of Porto Alegre

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain, Myofascial Pain Syndrome
Keywords
Handling, Musculoskeletal, Tissue, Subcutaneous, Myofascial Release, Instrument-Mobilized Soft Tissue Mobilization

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
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.
Allocation
Randomized
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
trial group
Arm Type
Experimental
Arm Description
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.
Arm Title
group control
Arm Type
Active Comparator
Arm Description
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 Type
Other
Intervention Name(s)
Instrument Assisted Soft Tissue Mobilization
Other Intervention Name(s)
IASTM
Intervention Description
Soft Tissue Mobilization
Intervention Type
Other
Intervention Name(s)
Manual Myofascial Release
Intervention Description
Myofascial Release Technique
Primary Outcome Measure Information:
Title
Evaluation of pain
Description
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.
Time Frame
assessment at baseline and its change in 1-week and 3-month follow-up
Title
Disability of the neck
Description
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.
Time Frame
assessment at baseline and its change in 1-week and 3-month follow-up
Title
Range of motion
Description
For measurement, an angular flexometer
Time Frame
assessment at baseline and its change in 1-week and 3-month follow-up
Secondary Outcome Measure Information:
Title
characterization of the sample
Description
quiz
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Federal university of health sciences of porto alegre
City
Porto Alegre
State/Province
Rio Grande Do Sul
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Raffaele C Greco
Phone
+5551992033035
Email
cunhagreco@yahoo.com.br
First Name & Middle Initial & Last Name & Degree
Raffaele C Greco
Facility Name
Universidade Federal de Ciências da Saúde de Porto Alegre
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90050-170
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francisco Araujo, Pt
Phone
+55 5192581467
Email
franciscoxaraujo@gmail.com
First Name & Middle Initial & Last Name & Degree
Francisco De Araujo, Pt

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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