CHRONIC NON-SPECIFIC NECK PAINNCT06799130
Instrument-Assisted Soft Tissue Mobilization Versus Muscle Energy Technique on Chronic Non-specific Neck Pain
A study testing instrument-assisted soft tissue mobilization and Muscle energy technique in people with CHRONIC NON-SPECIFIC NECK PAIN, run by Cairo University at 1 site in Egypt.
Trial summary
the aim of this study is to investigate if there is any difference between INSTRUMENT-ASSISTED SOFT TISSUE MOBILIZATION and Muscle Energy Technique over sternocleidomastoid on Neck pain, Range of motion and Functional disability in patients with Chronic Non-specific Neck Pain Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- CHRONIC NON-SPECIFIC NECK PAIN
- What is being tested?
- instrument-assisted soft tissue mobilization and Muscle energy technique
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 29 Jan 2025to 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 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The subjects are of both genders, aged between 18-35 years old .
- Subjects with Neck pain continued for at least the last 12 weeks .
- body mass index (18.5-24.9).
Who cannot join
- Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases
- Sensory problems at the mid or upper back .
- A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication .
- Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency .
- surgery of the cervical spine, whiplash trauma (in the past or recent, as cause of the complaint).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect Of Instrument-Assisted Soft Tissue Mobilization Versus Muscle Energy Technique Over Sternocleidomastoid In Patients With Chronic Non-Specific Neck Pain
the aim of this study is to investigate if there is any difference between INSTRUMENT-ASSISTED SOFT TISSUE MOBILIZATION and Muscle Energy Technique over sternocleidomastoid on Neck pain, Range of motion and Functional disability in patients with Chronic Non-specific Neck Pain
Read the detailed description
Non-specific neck pain (NSNP) is the most common and the 4th leading cause of musculoskeletal disorder worldwide. It is estimated that about 70% of the population experiences neck pain throughout life, with an annual incidence of 15% to 50%0. It is seen more commonly in middle-aged females. It has been well established that NSNP is not only the risk factor for developing severe spinal pathologies and functional disability but that it is also associated with decreasing the quality of life and productivity of workers. Pain, which leads to functional limitations especially in the cervical region, is associated with a decrease in the activation of the deep cervical flexors such as the longus colli and longus capitis muscles, and an increase in the activation of the superficial cervical flexors, such as SCM and anterior scalene muscles.It is reported that in individuals with CNP, there is an increase in the activation of SCM and anterior scalene muscles, especially during isometric cervical flexion and dynamic upper limb movements. In their study, Falla et al. concluded that individuals with unilateral CNP had muscle fatigue in their ipsilateral SCM and anterior scalene muscles. Wang et al. reported postural imbalance in individuals with CNP due to an increased activation and tightening of the suboccipital, SCM, upper trapezius, pectoralis, and rotator cuff muscles. A study by Mostafa et al., (2021) stated that IASTM has a favorable effect than conventional treatment in reduction mechanical neck pain, improvement cervical range of motion \&activity of daily living.
A Systematic Review by Sbardella et al., (2021) stated that all the studies analyzed show an effective improvement in the outcomes of pain, disability and joint function, which leads us to say that Muscle Energy Technique (MET) is certainly an effective and safe technique in the treatment of cervical pain.
this trail has three groups; one will receive IASTM+ conventional, the second will receive Muscle energy technique+ conventional and the third one will receive conventional treatment for four weeks
- Conditions
- CHRONIC NON-SPECIFIC NECK PAIN
- Being tested
- instrument-assisted soft tissue mobilization, Muscle energy technique
- Keywords
- instrument-assisted soft tissue mobilization, muscle energy technique
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
instrument-assisted soft tissue mobilizationOther
Also called IASTM
instrument-assisted soft tissue mobilization
Muscle energy techniqueOther
Muscle energy technique
| Study group | Role | What they receive |
|---|---|---|
| instrument-assisted soft tissue mobilization | Experimental | the patients will receive instrument-assisted soft tissue mobilization twice a week for four weeks over sternocleidomastoid muscle bilaterally utilizing an M2T blade. The subject lay comfortably in supine position on a treatment table. After using alcohol swabs to clean the patient's skin and the blade, a lubricant (Vaseline) will be applied, and a sweeping technique will be utilized to administer a thorough yet comfortable soft tissue mobilization on the sternocleidomastoid from origin to insertion for roughly 3 minutes.
conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise. Receives: Other: instrument-assisted soft tissue mobilization; Other: Muscle energy technique |
| Muscle energy technique | Experimental | the patients will receive post-isometric muscle relaxation(PIR) treatment for the sternocleidomastoid muscle, it will be applied from supine lying position with the head free from the plinth and held by the therapist's hand, the therapist placed one hand opposite the side of involvement muscle , The other hand is placed on the involved side of muscle . The patient pushed upward against the therapist's thumb on the forehead and looked up, then the patient will be asked to stop pushing and look down. After relaxation therapist will stretch the muscle for 30 seconds. This will be repeated 3 times bilaterally for 3 sessions per week for four weeks.
conventional therapy the patients will receive hot back for 15 minutes, neck range of motion, chin tuck, stretches and strengthen exercise. Receives: Other: instrument-assisted soft tissue mobilization; Other: Muscle energy technique |
| conventional therapy | Active comparator | the patients will receive conventional therapy three times a week for four weeks conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise. Receives: Other: instrument-assisted soft tissue mobilization; Other: Muscle energy technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity
the scale that will be used is VAS ; each subject will be instructed to put point on line from no pain to tolerable pain
Measured: up to four weeks
Secondary outcomes (2)
neck range of motion
will be measured by cervical range of motion device (CROM)
Measured: up to four weeks
neck disability
will be measured by Arabic version of neck disability index
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 posted29 Jan 2025
- Study start29 Jan 2025 (estimated)
- Primary completion15 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 CHRONIC NON-SPECIFIC 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
- instrument assisted soft tissue mobilization and muscle energy technique
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, alaa mohamed hassan saleh, Cairo University
- Investigators
- alaa saleh, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06799130
- Sponsor's protocol ID
- P.T.REC/012/005583
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 29 Jan 2025
- 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 29 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Instrument-Assisted Soft Tissue Mobilization Versus Muscle Energy Technique Over Sternocleidomastoid In Patients With Chronic Non-Specific Neck Pain
- ClinicalTrials.gov ID
- NCT06799130
- Acronym / sponsor ID
- P.T.REC/012/005583
- Conditions
- CHRONIC NON-SPECIFIC NECK PAIN
- Keywords
- instrument-assisted soft tissue mobilization, muscle energy technique
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 29 Jan 2025 (estimated)
- Primary completion
- 15 Mar 2025 (estimated)
- Study completion
- 30 Mar 2025 (estimated)
- First posted
- 29 Jan 2025 (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.
the aim of this study is to investigate if there is any difference between INSTRUMENT-ASSISTED SOFT TISSUE MOBILIZATION and Muscle Energy Technique over sternocleidomastoid on Neck pain, Range of motion and Functional disability in patients with Chronic Non-specific Neck Pain
Detailed description
Non-specific neck pain (NSNP) is the most common and the 4th leading cause of musculoskeletal disorder worldwide. It is estimated that about 70% of the population experiences neck pain throughout life, with an annual incidence of 15% to 50%0. It is seen more commonly in middle-aged females. It has been well established that NSNP is not only the risk factor for developing severe spinal pathologies and functional disability but that it is also associated with decreasing the quality of life and productivity of workers. Pain, which leads to functional limitations especially in the cervical region, is associated with a decrease in the activation of the deep cervical flexors such as the longus colli and longus capitis muscles, and an increase in the activation of the superficial cervical flexors, such as SCM and anterior scalene muscles.It is reported that in individuals with CNP, there is an increase in the activation of SCM and anterior scalene muscles, especially during isometric cervical flexion and dynamic upper limb movements. In their study, Falla et al. concluded that individuals with unilateral CNP had muscle fatigue in their ipsilateral SCM and anterior scalene muscles. Wang et al. reported postural imbalance in individuals with CNP due to an increased activation and tightening of the suboccipital, SCM, upper trapezius, pectoralis, and rotator cuff muscles. A study by Mostafa et al., (2021) stated that IASTM has a favorable effect than conventional treatment in reduction mechanical neck pain, improvement cervical range of motion \&activity of daily living.
A Systematic Review by Sbardella et al., (2021) stated that all the studies analyzed show an effective improvement in the outcomes of pain, disability and joint function, which leads us to say that Muscle Energy Technique (MET) is certainly an effective and safe technique in the treatment of cervical pain.
this trail has three groups; one will receive IASTM+ conventional, the second will receive Muscle energy technique+ conventional and the third one will receive conventional treatment for four weeks
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- instrument assisted soft tissue mobilization and muscle energy technique
| Arm | Type | Receives |
|---|---|---|
| instrument-assisted soft tissue mobilization | Experimental | Other: instrument-assisted soft tissue mobilization, Other: Muscle energy techniquethe patients will receive instrument-assisted soft tissue mobilization twice a week for four weeks over sternocleidomastoid muscle bilaterally utilizing an M2T blade. The subject lay comfortably in supine position on a treatment table. After using alcohol swabs to clean the patient's skin and the blade, a lubricant (Vaseline) will be applied, and a sweeping technique will be utilized to administer a thorough yet comfortable soft tissue mobilization on the sternocleidomastoid from origin to insertion for roughly 3 minutes. conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise. |
| Muscle energy technique | Experimental | Other: instrument-assisted soft tissue mobilization, Other: Muscle energy techniquethe patients will receive post-isometric muscle relaxation(PIR) treatment for the sternocleidomastoid muscle, it will be applied from supine lying position with the head free from the plinth and held by the therapist's hand, the therapist placed one hand opposite the side of involvement muscle , The other hand is placed on the involved side of muscle . The patient pushed upward against the therapist's thumb on the forehead and looked up, then the patient will be asked to stop pushing and look down. After relaxation therapist will stretch the muscle for 30 seconds. This will be repeated 3 times bilaterally for 3 sessions per week for four weeks. conventional therapy the patients will receive hot back for 15 minutes, neck range of motion, chin tuck, stretches and strengthen exercise. |
| conventional therapy | Active comparator | Other: instrument-assisted soft tissue mobilization, Other: Muscle energy techniquethe patients will receive conventional therapy three times a week for four weeks conventional therapy the patients will receive hot back for 15 minutes, neck range of motion (ROM), chin tuck, stretches and strengthen exercise. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- The subjects are of both genders, aged between 18-35 years old .
- Subjects with Neck pain continued for at least the last 12 weeks .
- body mass index (18.5-24.9).
Key exclusion criteria (5 listed)
- Any specific neck pathology as radiculopathy, rheumatoid arthritis, and systemic diseases
- Sensory problems at the mid or upper back .
- A tendency to hemorrhage or anticoagulation treatment. And nonsteroidal pain medication .
- Signs of severe pathology such as malignancy, fractures of the cervical spine, cervical radiculopathy or myelopathy, or vascular syndromes such as vertebrobasilar insufficiency .
- surgery of the cervical spine, whiplash trauma (in the past or recent, as cause of the complaint).
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 |
|---|---|---|
| instrument-assisted soft tissue mobilizationAlso: IASTMinstrument-assisted soft tissue mobilization | Other | Muscle energy technique, conventional therapy, instrument-assisted soft tissue mobilization |
| Muscle energy techniqueMuscle energy technique | Other | Muscle energy technique, conventional therapy, instrument-assisted soft tissue mobilization |
Primary outcome
pain intensity
Time frame: up to four weeks
the scale that will be used is VAS ; each subject will be instructed to put point on line from no pain to tolerable pain
2 secondary outcomes
neck range of motion
Time frame: up to four weeks
neck disability
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 29 Jan 2025.
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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.
alaa saleh principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing instrument-assisted soft tissue mobilization and Muscle energy technique in people with CHRONIC NON-SPECIFIC NECK PAIN, run by Cairo University at 1 site in Egypt.
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 3 inclusion and 5 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 29 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 alaa saleh (01121746761, alaanaqib168@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity (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 29 Jan 2025.