- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04702100
Instrument-assisted Soft Tissue Mobilization Versus Integrated on Mechanical Neck Pain (IASTM)
June 22, 2022 updated by: Al Shaymaa Shaaban Abd El Azeim, Cairo University
Instrument-assisted Soft Tissue Mobilization Versus Integrated Neuromuscular Inhibition Technique on Mechanical Non-specific Neck Pain
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
Study Overview
Status
Completed
Conditions
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
Study Type
Interventional
Enrollment (Actual)
90
Phase
- 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
-
-
-
Giza, Egypt, 12511
- Al Shaymaa Shaaban Abd El Azeim
-
-
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
Ages Eligible for Study
18 years to 35 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
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
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: instrument assisted soft tissue mobilization
the patients will receive instrument-assisted soft tissue mobilization+conventional therapy three times per week for four week
|
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.
the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
|
EXPERIMENTAL: integrated neuromuscular inhibition technique
the patients will receive integrated neuromuscular inhibition technique+ conventional therapy.
three times a week for four week
|
the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
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.
|
ACTIVE_COMPARATOR: conventional therapy
the patients will receive conventional therapy three times a week for four week
|
the patients will receive hot back for 10 minutes, active range of motion exercise, chin tuck, stretches
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain intensity
Time Frame: up to four weeks
|
The scale that will be used the VAS ;each subject will instructed to put point on line from no pain to tolerable pain
|
up to four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
neck disability
Time Frame: up to four weeks
|
will be measured by Arabic neck disability index
|
up to four weeks
|
muscle amplitude in the form of normalized root mean square (RMS)
Time Frame: up to four weeks
|
muscle amplitude will be measured by surface electromyography for upper trapezius
|
up to four weeks
|
muscle fatigue in the form of median frequency
Time Frame: up to four weeks
|
muscle fatigue will be measured by surface electromyography for upper trapezius
|
up to four weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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)
January 1, 2021
Primary Completion (ACTUAL)
March 30, 2021
Study Completion (ACTUAL)
March 30, 2021
Study Registration Dates
First Submitted
January 6, 2021
First Submitted That Met QC Criteria
January 7, 2021
First Posted (ACTUAL)
January 8, 2021
Study Record Updates
Last Update Posted (ACTUAL)
June 23, 2022
Last Update Submitted That Met QC Criteria
June 22, 2022
Last Verified
June 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- p.t.REC/012/003038
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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.
Clinical Trials on Non-specific Chronic Mechanical Neck Pain
-
Cairo UniversityCompletedChronic Non-Specific Neck PainEgypt
-
Beijing Sport UniversityCompletedChronic Non-specific Neck PainChina
-
Riphah International UniversityCompletedChronic Non-specific Neck PainPakistan
-
Université Catholique de LouvainFonds National de la Recherche ScientifiqueCompletedChronic Non-specific Neck PainBelgium
-
Quiropraxia y EquilibrioNot yet recruiting
-
University of JaenCompletedChronic Non-specific Neck PainSpain
-
NMP Medical Research InstituteYog-KulamCompletedChronic Non-Specific Neck PainIndia
-
Cairo UniversityActive, not recruitingChronic Non-specific Neck PainEgypt
-
Istituto Ortopedico RizzoliCompletedChronic Non-specific Neck PainItaly
-
Universität Duisburg-EssenCompleted
Clinical Trials on instrument assisted soft tissue mobilization
-
Kirsehir Ahi Evran UniversitesiCompletedMyofascial Pain | Instrument Assisted Soft Tissue MobilizationTurkey
-
Tokat Gaziosmanpasa UniversityCompleted
-
Saglik Bilimleri UniversitesiHarran UniversityRecruitingMusculoskeletal Pain | Musculoskeletal Disorder | Soreness, MuscleTurkey
-
KTO Karatay UniversityCompleted
-
Youngstown State UniversityCompleted
-
Eastern Mediterranean UniversityCompletedChronic Low-back PainCyprus
-
Hannah AntonyNot yet recruiting
-
Florida Gulf Coast UniversityThomas Zeller; Tyler Corbin; Alyssa NievesCompletedAsymptomatic ConditionUnited States
-
Riphah International UniversityCompletedMechanical Neck PainPakistan
-
Riphah International UniversityCompleted