Mechanical Neck PainMNPNCT06720116
Sustained Natural Apophysial Glide Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Neck Pain
A study testing sustained natural apophysial glide, instrument assisted soft tissue mobilization and conventional physical therapy in people with Mechanical Neck Pain, run by Cairo University.
Trial summary
this study will be conducted to investigate the effect of sustained natural apophysial glide and Instrument assisted soft tissue mobilization on pain intensity, cervical range of motion and neck functional disability level in patients with chronic mechanical neck pain Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Mechanical Neck Pain
- What is being tested?
- sustained natural apophysial glide, instrument assisted soft tissue mobilization and conventional physical therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 10 Dec 2024to 30 Mar 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Malignancy
- cervical and cranial surgery
- Recent fractures
- spinal tumors
- severe disc herniation
- uncontrolled hypertension
- Heart Disease ( arrhythmia, pacemaker).
- Pregnant and breast feeding women.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
this study will be conducted to investigate the effect of sustained natural apophysial glide and Instrument assisted soft tissue mobilization on pain intensity, cervical range of motion and neck functional disability level in patients with chronic mechanical neck pain
Read the detailed description
Neck pain is a common musculoskeletal disorder in the era of technology. The International Association for the Study of Pain (IASP) has defined neck pain as:"Pain perceived as arising from anywhere with in the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by saggital plane tangential to the lateral border of neck. Mulligan pioneered specific manual approach called mobilization with movement (MWM).The advance of this approach was aimed for application on the spinal joints. He claimed that his technique could improve the spinal range of motion (ROM) and decrease pain through the correction of a positional fault occurring between the surfaces of the involved facet joints. The most commonly used Mulligan technique is called "sustained natural apophyseal glides" or SNAGs, this technique has introduced in 1999 by Mulligan and is performed by applying an accessory glide along the axis of the facet joint of the affected level while the patient is doing an active movement from weight-bearing position. The pressure applied by the therapist in a cephalad direction over the spinous process (centrally) or the transverse process (unilaterally) or to the articular pillar of the affected vertebra.The IASTM therapy is designed to promote the restart of connective tissues by resorbing extra fibroses, encouraging collagen secondary to fibroblast recruited healing. In turn this leads to scar tissues, adhesions, and fascial limitations being released and broken down. M2t blade is a multifunctional instrument invented by Adam Bro ger that is reasonable in price and has many planes that can be used in treatment. Its efficiency in improving patients symptoms was proven through many studies. sixty patients with mechanical neck pain will be assigned randomly into three equal group; group A will receive mulligan plus traditional, group B will receive IASTM plus traditional and group C will receive traditional only
- Conditions
- Mechanical Neck Pain
- Being tested
- sustained natural apophysial glide, instrument assisted soft tissue mobilization, conventional physical therapy
- Keywords
- Sustained Natural Apophysial Glide, instrument Assisted Soft Tissue Mobilization, Chronic Mechanical Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sustained natural apophysial glideOther
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
instrument assisted soft tissue mobilizationOther
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.
conventional physical therapyOther
the patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises
| Study group | Role | What they receive |
|---|---|---|
| sustained natural apophysial glide | Experimental | 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 Receives: Other: sustained natural apophysial glide; Other: conventional physical therapy |
| instrument assisted soft tissue mobilization | Experimental | 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. Receives: Other: instrument assisted soft tissue mobilization; Other: conventional physical therapy |
| conventional therapy | Active comparator | 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. Receives: Other: conventional physical therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
neck disability
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
Measured: up to four weeks
Secondary outcomes (2)
pain intensity
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.
Measured: up to four weeks
cervical range of motion
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.
Measured: up to four weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2024
- Study start10 Dec 2024 (estimated)
- Primary completion30 Mar 2025 (estimated)
- Study completion30 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Neck PainStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- mulligan and iASTM groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Menna Allah Hesham Abd elfatah, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06720116
- Sponsor's protocol ID
- P.T.REC/012/005464
- Acronym
- MNP
- Status last verified
- Nov 2024
- First submitted
- 3 Dec 2024
- Last updated
- 6 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sustained Natural Apophysial Glide Versus Instrument Assisted Soft Tissue Mobilization in Patients With Chronic Mechanical Neck Pain
- ClinicalTrials.gov ID
- NCT06720116
- Acronym / sponsor ID
- MNP / P.T.REC/012/005464
- Conditions
- Mechanical Neck Pain
- Keywords
- Sustained Natural Apophysial Glide, instrument Assisted Soft Tissue Mobilization, Chronic Mechanical Neck Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Dec 2024 (estimated)
- Primary completion
- 30 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 6 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
this study will be conducted to investigate the effect of sustained natural apophysial glide and Instrument assisted soft tissue mobilization on pain intensity, cervical range of motion and neck functional disability level in patients with chronic mechanical neck pain
Detailed description
Neck pain is a common musculoskeletal disorder in the era of technology. The International Association for the Study of Pain (IASP) has defined neck pain as:"Pain perceived as arising from anywhere with in the region bounded superiorly by superior nuchal line, inferior by an unoriginally transverse line through the tip of first thoracic spinous process, and laterally by saggital plane tangential to the lateral border of neck. Mulligan pioneered specific manual approach called mobilization with movement (MWM).The advance of this approach was aimed for application on the spinal joints. He claimed that his technique could improve the spinal range of motion (ROM) and decrease pain through the correction of a positional fault occurring between the surfaces of the involved facet joints. The most commonly used Mulligan technique is called "sustained natural apophyseal glides" or SNAGs, this technique has introduced in 1999 by Mulligan and is performed by applying an accessory glide along the axis of the facet joint of the affected level while the patient is doing an active movement from weight-bearing position. The pressure applied by the therapist in a cephalad direction over the spinous process (centrally) or the transverse process (unilaterally) or to the articular pillar of the affected vertebra.The IASTM therapy is designed to promote the restart of connective tissues by resorbing extra fibroses, encouraging collagen secondary to fibroblast recruited healing. In turn this leads to scar tissues, adhesions, and fascial limitations being released and broken down. M2t blade is a multifunctional instrument invented by Adam Bro ger that is reasonable in price and has many planes that can be used in treatment. Its efficiency in improving patients symptoms was proven through many studies. sixty patients with mechanical neck pain will be assigned randomly into three equal group; group A will receive mulligan plus traditional, group B will receive IASTM plus traditional and group C will receive traditional only
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- mulligan and iASTM groups
| Arm | Type | Receives |
|---|---|---|
| sustained natural apophysial glide | Experimental | Other: sustained natural apophysial glide, Other: conventional physical therapypatients 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 |
| instrument assisted soft tissue mobilization | Experimental | Other: instrument assisted soft tissue mobilization, Other: conventional physical therapypatients 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. |
| conventional therapy | Active comparator | Other: conventional physical therapypatients 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. |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Malignancy
- cervical and cranial surgery
- Recent fractures
- spinal tumors
- severe disc herniation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sustained natural apophysial glideThe 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 | Other | sustained natural apophysial glide |
| instrument assisted soft tissue mobilizationThe 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. | Other | instrument assisted soft tissue mobilization |
| conventional physical therapythe patients will receive conventional physical therapy in the form of Infrared, TENS , stretching exercices, isometric exercises | Other | conventional therapy, instrument assisted soft tissue mobilization, sustained natural apophysial glide |
Primary outcome
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
2 secondary outcomes
pain intensity
Time frame: up to four weeks
cervical range of motion
Time frame: up to four weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing sustained natural apophysial glide, instrument assisted soft tissue mobilization and conventional physical therapy in people with Mechanical Neck Pain, run by Cairo University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact menna allah abd elfatah, master (01006932687, menahesham2761@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
neck disability (time frame: up to four weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2024.