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Neck PainNCT03563079

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

A study testing Instrument Assisted Soft Tissue Mobilization and Manual Myofascial Release in people with Neck Pain and Myofascial Pain Syndrome, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Neck Pain, Myofascial Pain Syndrome
What is being tested?
Instrument Assisted Soft Tissue Mobilization and Manual Myofascial Release
Could I receive a placebo?
No, everyone receives an active treatment
How many people
6 participants
Where
2 sitesBrazil
Study dates
30 Apr 2018to 10 May 2019
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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%.

Who cannot join

  • 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;
Show all 17Show fewer
  • 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.

Trial locations and contacts

2 sites in 1 country.

Brazil2 sites, 2 recruiting

  • Federal university of health sciences of porto alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

    Raffaele C Greco, +5551992033035, cunhagreco@yahoo.com.br

    Raffaele C Greco

    Recruiting

  • Universidade Federal de Ciências da Saúde de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

    Francisco Araujo, Pt, +55 5192581467, franciscoxaraujo@gmail.com

    Francisco De Araujo, Pt

    Recruiting

Other trials in Brazil

About this study

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

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.

Read the 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.
Being tested
Instrument Assisted Soft Tissue Mobilization, Manual Myofascial Release
Keywords
Handling, Musculoskeletal, Tissue, Subcutaneous, Myofascial Release, Instrument-Mobilized Soft Tissue Mobilization
Medical subject headings
Neck Pain, Myofascial Pain Syndromes

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Instrument Assisted Soft Tissue MobilizationOther

    Also called IASTM

    Soft Tissue Mobilization

  • Manual Myofascial ReleaseOther

    Myofascial Release Technique

Study groups in NCT03563079
Study groupRoleWhat they receive
trial groupExperimentalThe 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.
Receives: Other: Instrument Assisted Soft Tissue Mobilization
group controlActive comparatorTreatment 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.
Receives: Other: Manual Myofascial Release

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: assessment at baseline and its change in 1-week and 3-month follow-up

  2. 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.

    Measured: assessment at baseline and its change in 1-week and 3-month follow-up

  3. Range of motion

    For measurement, an angular flexometer

    Measured: assessment at baseline and its change in 1-week and 3-month follow-up

Secondary outcomes (1)

  1. characterization of the sample

    quiz

    Measured: baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jun 2018
  2. Study start30 Apr 2018
  3. Primary completion20 Apr 2019 (estimated)
  4. Study completion10 May 2019 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Randomized clinical trial
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
6 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03563079
Sponsor's protocol ID
FAraujo
Status last verified
Jun 2018
First submitted
25 May 2018
Last updated
21 Jun 2018
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Instrument Assisted Soft Tissue Mobilization and Manual Myofascial Release in people with Neck Pain and Myofascial Pain Syndrome, run by Federal University of Health Science of Porto Alegre at 2 sites in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluation of pain (time frame: assessment at baseline and its change in 1-week and 3-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03563079.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2018.

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