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
|Condition or disease||Intervention/treatment||Phase|
|Neck Pain Myofascial Pain Syndrome||Other: Instrument Assisted Soft Tissue Mobilization Other: Manual Myofascial Release||Not Applicable|
- 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 :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|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.|
|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|
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
- 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
- characterization of the sample [ Time Frame: baseline ]quiz
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
|Federal university of health sciences of porto alegre||Recruiting|
|Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170|
|Contact: Raffaele C Greco +5551992033035 firstname.lastname@example.org|
|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 email@example.com|
|Principal Investigator: Francisco De Araujo, Pt|