- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06720116
Sustained Natural Apophysial Glide Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Neck Pain (MNP)
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: menna allah abd elfatah, master
- Phone Number: 01006932687
- Email: menahesham2761@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Sixety patients of chronic mechanical neck pain diagnosed and reffered from physicians will be participants in the study .
- Patients of both genders will be included.
- The age of the participants will beranged from 20 and 55 years
- The BMI ranged between 18.9 and 25 kg/m2
- All patients who suffered from neck pain more than 3 months.
Exclusion Criteria:
- Malignancy
- cervical and cranial surgery
- Recent fractures
- spinal tumors
- severe disc herniation
- uncontrolled hypertension
- Heart Disease ( arrhythmia, pacemaker).
- Pregnant and breast feeding women.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: sustained natural apophysial glide
patients will receive sustained natural apophysial glide( SNAGS ) in addition to conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month
|
The patients will be in the sitting position and asked to move their head in the direction that particularly produces their symptoms. As the participant moves their head, the physiotherapist gently glides the painful vertebra anteriorly and sustains the glide through the movement. During the application of the glide, the participant should stay symptom free and is instructed to stop moving if any PAIN is produced. This movement was repeated for 10 times for 3 sets, The interval between the sets was 15 to 20 seconds.After mobilization subject had to perform same exercises as conventional group plus conventional physical therapy
the patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises
|
|
Experimental: instrument assisted soft tissue mobilization
patients will receive instrument assisted soft tissue mobilization ( IASTM) technique in addition to conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month.
|
the patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises
The subject will be in comfortable sitting position leaning on a treatment table with the arm crossed to rest the head. After cleaning the skin of the subject and the blade with alcohol swabs, a lubricant (Vaseline) was applied, and a sweeping technique was used to apply a deep yet comfortable soft tissue mobilization on the upper trapezius from origin to insertion for approximately 3 min. First, M2T blade will be utilized to locate the precise locations of limitation in the affected muscles. Second, the M2T blade was put at 45 degree angle by using convex surface to apply gentle strokes along the muscle. Subjects were instructed that slight hyperemia on the skin is a normal feeling and should subside before the next session. |
|
Active Comparator: conventional therapy
patients will receive conventional therapy in the form of ( Infrared, TENS , stretching exercices, isometric exercises) for chronic mechanical neck pain ,3 sessions per week for one month.
|
the patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
neck disability
Time Frame: up to four weeks
|
Assessment of neck disability will be performed by Arabic version of neck disability index .It is valid and reliable tool in the assessment of neck function.
The NDI can be calculated as a raw score or as a percentage Each segment is graded on a scale of 0 to 5, with 0 representing "no discomfort" and 5 suggesting "the most excruciating pain imaginable."
With a maximum score of 50 as following
|
up to four weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
pain intensity
Time Frame: up to four weeks
|
pain intensity will be measured by visual analogue scale.
It is a 10-cm (100-mm) line; with 0 refer to no pain while 100mm refer to extreme pain.
Patients were requested to place a mark along the line to express their level of pain.
The reliability VAS is moderate to good in subjects with musculoskeletal conditions.
|
up to four weeks
|
|
cervical range of motion
Time Frame: up to four weeks
|
cervical range of motion device will be used to measure the neck ROM for flexion, extension, rotations, and lateral flexion using 3 separate inclinometers which are attached to a plastic frame and secured to the head by Velcro strap and nose bridge.
The sagittal plane inclinometer measures flexion - extension, the frontal plane inclinometer measures right and left lateral flexion, and the horizontal plane inclinometer with a magnetic neck collar measures right and left rotation.
|
up to four weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P.T.REC/012/005464
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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