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Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain (IASTM)

Primary Purpose

Non-specific Chronic Mechanical Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
instrument assisted soft tissue mobilization
integrated neuromuscular inhibition technique
conventional therapy
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Non-specific Chronic Mechanical Neck Pain focused on measuring instrument-assisted soft tissue mobilization, integrated neuromuscular inhibition technique

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern
  2. body mass index from 18 to 25 kg/m2
  3. their ages from 18-35

Exclusion Criteria:

  1. if they had trigger point injections within the past 6 months
  2. history of neck or upper back surgery, trauma or fracture
  3. history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities
  4. cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases

Sites / Locations

  • Al Shaymaa Shaaban Abd El Azeim

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

instrument assisted soft tissue mobilization

integrated neuromuscular inhibition technique

conventional therapy

Arm Description

the patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week

the patients will receive integrated neuromuscular inhibition technique+ conventional therapy. three times a week for four week

the patients will receive conventional therapy three times a week for four week

Outcomes

Primary Outcome Measures

pain intensity
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain

Secondary Outcome Measures

neck disability
will be measured by Arabic neck disability index
muscle amplitude in the form of normalized root mean square (RMS)
muscle amplitude will be measured by surface electromyography for upper trapezius
muscle fatigue in the form of median frequency
muscle fatigue will be measured by surface electromyography for upper trapezius

Full Information

First Posted
January 6, 2021
Last Updated
June 22, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04702100
Brief Title
Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain
Acronym
IASTM
Official Title
Instrument-assisted Soft Tissue Mobilization Versus Integrated Neuromuscular Inhibition Technique on Mechanical Non-specific Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2021 (Actual)
Primary Completion Date
March 30, 2021 (Actual)
Study Completion Date
March 30, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
the aim of this study is to investigate the efficacy of instrumented assisted soft tissue mobilization versus integrated neuromuscular inhibition technique on mechanical non-specific neck pain
Detailed Description
Mechanical neck pain is a prevalent condition in various populations. Neck pain occurrence is affected by several factors, involving environmental, psychological, and social aspects. Neck pain represents the fourth major disorder responsible for a person's year lived with disability and ranked eleventh as disability-adjusted life years of a person. The neck pain incidence ranges from 10.4 to 23.3% in 1-year time, while the range of prevalence was 0.4 to 86.8%. It has a high prevalence among computer users, office workers, and females, especially females aged 35 to 49 years old. Myofascial trigger point (MTrP) might play an important role in the formation of mechanical neck pain and is known as a hyperirritable spot in skeletal muscle that is accompanied with a hypersensitive palpable nodule in a taut band. IASTM and integrated play an important role in the treatment of mechanical neck pain.this trial has three groups; one will receive IASTM+ conventional, the second will receive integrated + conventional and the third will receive conventional treatment for four week

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Non-specific Chronic Mechanical Neck Pain
Keywords
instrument-assisted soft tissue mobilization, integrated neuromuscular inhibition technique

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
instrument assisted soft tissue mobilization and integrated neuromuscular inhibition technique
Masking
ParticipantOutcomes Assessor
Masking Description
random generator
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
instrument assisted soft tissue mobilization
Arm Type
Experimental
Arm Description
the patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week
Arm Title
integrated neuromuscular inhibition technique
Arm Type
Experimental
Arm Description
the patients will receive integrated neuromuscular inhibition technique+ conventional therapy. three times a week for four week
Arm Title
conventional therapy
Arm Type
Active Comparator
Arm Description
the patients will receive conventional therapy three times a week for four week
Intervention Type
Other
Intervention Name(s)
instrument assisted soft tissue mobilization
Intervention Description
the patients will receive instrument-assisted soft tissue mobilization:The subject was seated in a relaxed sitting position. M2T blade was used to find specific areas of restriction on RT upper trapezius. Then treatment plane 1 - 2 and 3 were used.The lubricant (Vaseline) was applied to the skin around the neck area prior to treatment and the tool was cleaned with an alcohol preparation pad. Then by using M2T blade with angle 45, we were giving long slow strokes without causing any discomfort or pain over muscle starting from its insertion up to its origin approximately for 2 to 3 min repeated two times.
Intervention Type
Other
Intervention Name(s)
integrated neuromuscular inhibition technique
Intervention Description
will receive integrated neuromuscular inhibition technique: from supine lying position.we the patients will perform ischemic compression at trigger points then positional release technique and finally muscle energy technique.
Intervention Type
Other
Intervention Name(s)
conventional therapy
Intervention Description
the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
Primary Outcome Measure Information:
Title
pain intensity
Description
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
Time Frame
up to four weeks
Secondary Outcome Measure Information:
Title
neck disability
Description
will be measured by Arabic neck disability index
Time Frame
up to four weeks
Title
muscle amplitude in the form of normalized root mean square (RMS)
Description
muscle amplitude will be measured by surface electromyography for upper trapezius
Time Frame
up to four weeks
Title
muscle fatigue in the form of median frequency
Description
muscle fatigue will be measured by surface electromyography for upper trapezius
Time Frame
up to four weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: diagnosed as non-specific neck pain with upper trapezius active myofascial trigger points less than 3 months of duration and have these criteria: taut band on palpation, hyper sensible tender spot in the taut band, local twitch response referred pain pattern body mass index from 18 to 25 kg/m2 their ages from 18-35 Exclusion Criteria: if they had trigger point injections within the past 6 months history of neck or upper back surgery, trauma or fracture history of a whiplash injury, skin diseases and lesions, any sensory disturbances, any vascular syndromes, neck and back deformities cervical radiculopathy, and diagnosis of fibromyalgia syndrome, skin diseases
Facility Information:
Facility Name
Al Shaymaa Shaaban Abd El Azeim
City
Giza
ZIP/Postal Code
12511
Country
Egypt

12. IPD Sharing Statement

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Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain

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