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

NCT03563079 | Unknown DMC

• 1 other identifier: FAraujo
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Neck Pain; Myofascial Pain Syndrome

Keywords

Handling, Musculoskeletal; Tissue, Subcutaneous; Myofascial Release; Instrument-Mobilized Soft Tissue Mobilization

Outcome Measures

Primary Outcomes (3)

• 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.

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

• 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.

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

• Range of motion

  For measurement, an angular flexometer

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

Secondary Outcomes (1)

• characterization of the sample

  baseline

Study Arms (2)

trial group

EXPERIMENTAL

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

group control

ACTIVE COMPARATOR

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

Interventions

Instrument Assisted Soft Tissue Mobilization OTHER

Soft Tissue Mobilization

Also known as: IASTM

trial group

Manual Myofascial Release OTHER

Myofascial Release Technique

group control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Federal University of Health Science of Porto Alegre: lead

Study Sites (2)

Federal university of health sciences of porto alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

Universidade Federal de Ciências da Saúde de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90050-170, Brazil

RECRUITING

MeSH Terms

Conditions

Neck Pain; Myofascial Pain Syndromes

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: May 25, 2018
• First Posted: June 20, 2018
• Study Start: April 30, 2018
• Primary Completion: April 20, 2019
• Study Completion: May 10, 2019
• Last Updated: June 21, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)