Effect of Instrument-assisted Soft Tissue Mobilization Versus Myofascial Release in Treatment of Mechanical Neck Pain

March 24, 2022 updated by: Fatma Abdelfattah Hanafy shewail, Cairo University
Mechanical neck pain has become a major health problem recently, affecting around one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years causing pain and functional deficits. No study has been conducted before to investigate the effect of Instrument assisted soft tissue mobilization (IASTM) with mechanical neck pain on university students involved in distance learning.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Mechanical neck pain is a major social and economic burden. It showed a one-year prevalence ranging from 42 to 67% in young adults aged 20-24 years. Treatment of neck pain is costly in terms of utilization of health care services, disability, compensation payments and lost work productivity. With the increasing prevalence of pain and disability associated with musculoskeletal impairments, it is essential to identify the most efficacious interventions to maximize patient outcomes and decrease the societal burden.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
35

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 34518
        • Outpatient clinic, Faculty of Physical Therapy, Misr university for scientific and technology, Egypt

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patient's age will be between 18-25 years old.
  2. Subjects with mechanical neck pain localized to cervical and periscapular region.
  3. Subjects with at least one trigger point in the upper trapezius and/or levator scapulae muscles
  4. Subjects should report mechanical neck pain of at least 30 mm on a visual analogue scale (VAS). The scale is ranged from 0 mm (no pain) to 100 mm (worst imaginable pain).
  5. Subjects who use computers daily for at least two hours and are involved in distance learning for at least three months.

Exclusion Criteria:

  1. Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases.
  2. Sensory problems at mid or upper back
  3. A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication
  4. History of head and upper trunk trauma or surgery.
  5. Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: IASTM group
Group (A) will receive IASTM on the right upper trapezius and levator scapulae twice a week for four weeks in addition to a postural correction program.
Other: Instrument-assisted soft tissue mobilization
For IASTM, the subject will be seated in a comfortable position. The subject's forehead will be rested on his/her forearm on a table in front of him/her. A lubricant (Vaseline) will be applied to the skin around the neck area prior to treatment and the M2T blade will be cleaned with an alcohol pad. The M2T blade will be used, at an angle of 45 without causing discomfort or pain, from the muscle origin to its insertion (sweeping technique), for approximately 3 min. Subjects will be instructed to put an ice pack on the area if they feel any burning sensations after the session. This procedure will be repeated twice a week for four weeks.
Other: Postural correction exercises (PCE)
Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks. The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness. Exercises will be performed while the patients in a neutral sitting posture
Experimental: myofascial release group
Group (B) will receive a myofascial release on the right upper trapezius and levator scapulae twice a week for four weeks in addition to the postural correction program.
Other: Postural correction exercises (PCE)
Postural correction exercises will be applied for patients in groups A and B. This program will be conducted according to the protocols of exercise will be performed as 3 sets of 10 repetitions each for 2 times/ week for 4 weeks. The patients will be instructed to continue the exercises as a daily home program to influence the self-correction kinesthetic awareness. Exercises will be performed while the patients in a neutral sitting posture
Other: Myofascial release therapy
Firstly, the subject will lay supine with no pillow under his/ her head then the subject will rotate his/her head and neck away from the side which will be treated. Therapist will sit or stand at the corner, edge or top of the treatment table and therapist will place one hand proximal to the shoulder with skin on skin and therapist's fingers pointing towards the subject's elbow on the same side. Other hand of the therapist will be placed inferior to the subject's jaw (body of the mandible), using it as a handle, with fingers pointing towards the top of the subject's head. Then therapist will lean into the subject to the tissue depth barrier, wait and follow each subtle release three-dimensionally. Therapist should avoid forcing the tissue or slipping or gliding over the skin. The technique should be applied for at least five minutes for optimal results. This procedure will be repeated twice a week for four weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pain intensity assessment
Time Frame: at baseline and after 4 weeks of intervention
Assessing the change in pain intensity via using visual analogue scale which will be used to examine pain intensity. It consists of a continuous 10 cm line. The patient will be instructed to place a vertical mark on the line to indicate his/her pain, ranging from no pain or discomfort (0), to the worst pain he/she could possibly feel . Using the visual analogue scale allows the patient freedom to record and not restricting him by numbers.
at baseline and after 4 weeks of intervention
Neck disability index
Time Frame: at baseline and after 4 weeks of intervention
Assessing the change in neck disability via using Neck disability index which is is a self-reported outcome measure which is commonly used to determine the perceived disability in patients with neck pain. It consists of 10 items; 7 related to activities of daily living, (ADL), 2 related to pain, and 1 related to concentration. Each item is scored from 0-5 and the total score is expressed as percentage, with higher scores corresponding to greater disability.
at baseline and after 4 weeks of intervention
Muscle pressure intensity
Time Frame: at baseline and after 4 weeks of intervention
Assessing the change in Muscle pressure intensity via using Pressure Algometer which is a handheld device that applies a manual pressure stimulus to assess pressure intensity. It has been broadly used and validated. A pressure threshold algometer will be used to measure the pressure pain threshold of a Trigger points of the upper trapezius and levator scapulae muscle before and aftertreatment.
at baseline and after 4 weeks of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Fatma Hanafy, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 15, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 22, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Fatma_phd_2022

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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