Levator Scapulae SyndromeLSSNCT07208396
Upper Cervical Mobilization Versus Integrated Neuromuscular Inhibition Technique in Patients With Levator Scapulae Syndrome
A study testing Upper cervical mobilization, Integrated neuromuscular inhibition technique and Conventional treatment in people with Levator Scapulae Syndrome, run by Cairo University.
Trial summary
the study will be conducted to answer the following research question: is there a difference between the effect of upper cervical mobilization and integrated neuromuscular inhibition technique of levator scapulae muscle in patients with levator scapulae syndrome? Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Levator Scapulae Syndrome
- What is being tested?
- Upper cervical mobilization, Integrated neuromuscular inhibition technique and Conventional treatment
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 2025to 5 Jun 2026
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with a primary complaint of chronic neck pain (assessed by VAS) for more than 3 months.
- Subjects with pain provocation and reduced mobility at the upper cervical segment (assessed by passive accessory intervertebral movements (PAIVMs) and reduced mobility at cervical spine (assessed by CROM) will be included in the study.
- Participants will be recruited from both genders with age ranged from 18 to 45 years old, and BMI from 18 to 30kg/m2
Who cannot join
- 1) Previous spine surgery 2) Pregnant and breast feeding women 3) Diabetic patients 4) Hypertensive patients 5) Neck pain associated with cervical radiculopathy 6) Whiplash injuries 7) Cervical spine fracture 8) Vertebrobasilar insufficiency. 9) Red flags suggesting of cancer, infection, vascular insufficiency
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
Official title: UPPER CERVICAL MOBILIZATION VERSUS INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE IN PATIENTS WITH LEVATOR SCAPULAE SYNDROME
the study will be conducted to answer the following research question: is there a difference between the effect of upper cervical mobilization and integrated neuromuscular inhibition technique of levator scapulae muscle in patients with levator scapulae syndrome?
Read the detailed description
Neck pain might be usually provoked by TrPs in the upper trapezius and levator scapulae muscles The differentiation in levator scapulae MTrPs prevalence between the right and left sides may also indicate potential asymmetries in muscle use or stress, which could be relevant for diagnosis and treatment strategies.
Integrated treatment approach (INIT) for neck pain provides greater pain relief, reduces disability, improves functional ability, and improves quality of life than other treatments Cervical Spine Mobilization (CSM) by oscillatory movements and traction to the cervical segments helps to break adhesion and stretch the hypo-mobile shortened structures.
There is a gap in the available literature about the comparative effect of upper cervical mobilization and integrated neuromuscular inhibition technique (INIT) of levator scapulae muscle on neck pain, neck disability, range of motion, and cervical proprioception in levator scapulae syndrome.
60 Participants recruited from both genders will be assigned randomly into 3 equal groups Group A : will receive upper cervical mobilization plus conventional treatment .
Group B : will receive integrated neuromuscular technique, It is a technique which combines three methods (Ischemic compression- muscle energy technique- strain counter strain) plus conventional treatment .
Group C : will receive conventional physical therapy only in the form of: (superficial heat using hot pack for 10 minutes ,Isometric Neck Exercises and Dynamic Neck) .
- Conditions
- Levator Scapulae Syndrome
- Being tested
- Upper cervical mobilization, Integrated neuromuscular inhibition technique, Conventional treatment
- Keywords
- trigger points
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Upper cervical mobilizationOther
All patients in group A will receive Grades I and II mobilizations in the first two sessions to reduce pain. In subsequent sessions, patients will receive Grades III and IV mobilizations; typically will be utilized to stretch the joint capsule and passive tissues, which provide stability to the joint, thereby increasing ROM. Maitland usually performs treatment techniques in an oscillatory manner. These oscillations can be performed with different amplitudes in different positions in the range of movement.
The mobilizations will be delivered in the prone position. The duration of mobilization will be 30-s bouts given for three sets. The therapist places a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand will be placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force will be directed dorsally from the shoulder until the therapist
Integrated neuromuscular inhibition techniqueOther
An integrated approach to myofascial trigger point release is achieved by combining several manual therapy techniques under the name INIT (Integrated Neuromuscular Inhibition Technique). The technique combines MET and SCS with ischemic compression in one coordinated technique .
First, intermittent compression(IC) was initiated by using the thumb and index finger to apply a pincer grip to the TrP in the middle of the UT.
Second, the strain counter strain (SCS) began by applying pressure to the trigger point . The participants' heads were passively flexed laterally to the affected side. and then asked the patient about pain.
Third, the MET begins with one of the investigator's hands stabilizing the affected shoulder and the other on the head side. The participant was asked to move the stabilized shoulder and head in the direction of the other. This contraction lasted 7 seconds and had a maximum voluntary contraction of 20%. After that, the muscle was lengthened for 30 seconds
Conventional treatmentOther
- Hot packs Hot pack will be applied at the beginning of the treatment session for all patients participated in the study. The participants will be in prone lying position. The neck and upper thoracic region will be exposed. The hot pack then will be applied for 10 minutes on cervical and upper thoracic region.
- Dynamic neck exercise: Dynamic neck exercises include lifting head up with the chin tucked in from supine lying for neck flexion, lifting head backwards in prone lying for neck extension lifting head sideways from pillow in side lying position for neck side flexion which will be also repeated for the other side.
- Isometric Neck Exercises The exercises will be performed in sitting position, by holding the theraband directly forwards for neck flexion, backwards for neck extension and obliquely towards right and left and by crossing over the band for neck side flexion and rotation. All these will be done for all patients participated in the study for about 5-10 repetition
| Study group | Role | What they receive |
|---|---|---|
| UPPER CERVICAL MOBILIZATION | Experimental | All patients in group A will receive Grades I and II mobilizations and conventional physical therapy program in the form of :( hot pack, Dynamic and Isometric Neck Exercises) for four weeks. Receives: Other: Upper cervical mobilization |
| Integrated neuromuscular inhibition technique | Experimental | Group B will receive integrated neuromuscular inhibition Technique and conventional physical therapy program as in group A in the form of :( hot pack, Dynamic and Isometric Neck Exercises) for four weeks. Receives: Other: Integrated neuromuscular inhibition technique |
| conventional treatment | Active comparator | Participants in group C will receive conventional physical therapy only in the form of: (superficial heat using hot pack for 10 minutes, Dynamic Neck Exercises and Isometric Neck Exercises) for four weeks Receives: Other: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain pressure threshold of trigger points
The Pressure Pain Threshold (PPT) is defined as the point at which a non-painful pressure stimulus turns into a painful pressure sensation. Pressure algometry (PA) is a method described to objectify this PPT. This technique is a well-known and well-validated method to induce acute experimental pain. Different studies have been published about using this tool to evaluate pain in different locations of the body and showed high levels of reliability.
Measured: up to 4 weeks
Measurement of Neck Functional Disability Level using the Arabic Version of Neck Disability Index
The patient will be relaxed and asked to complete the NDI before treatment and after treatment, which consists of 10 items. Each item is scored from zero (no disability) to five (total disability), with the maximum possible total score being 50. For each item, the subject asked to choose one answer that best defined his/her neck functional disability level. Scores for each item tallied and the total score will be recorded. Mean duration of the test: 3 to 7.8 minutes. Vernon and Mior presented the following interpretation
Measured: up to 4 weeks
Secondary outcomes (2)
Measurement of cervical proprioception
Most assessment techniques currently available evaluate the integrity and function of efferent pathways or the final outcome of skeletal muscle activation or a combination of both Joint position sense is one dimension of proprioception, classically assessed by the ability to accurately reproduce preselected target positions or a specific joint angle . The test usually involves some type of position matching procedure, in which a target joint position is presented and the subject must match that position. The absolute difference between the target and the matching joint positions is often used as a measure of position sense accuracy in terms of the repositioning error.
Measured: up to 4 weeks
Range of motion assessment of cervical spine
Cervical active range of motion (AROM) in flexion and extension, right/left side bending and right/left rotation will be measured for each subject.
Measured: up to 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2025
- Study start20 Oct 2025 (estimated)
- Primary completion5 Jun 2026 (estimated)
- Study completion5 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Levator Scapulae SyndromeStudies 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
- The Integrated Neuromuscular Inhibition Technique (INIT) is an approach that combines three interventions: Ischemic Compression, Strain Counter Strain, and Muscle Energy Technique. INIT aims to stretch the fascia and muscle structures and increase muscle flexibility, prevent and eliminate taut bands/trigger points and adhesions on the fascia, eliminate complaints of pain and headaches, reduce stiffness, and improve functional abilities . Cervical mobilization is the common approach used by physical therapists to treat mechanical neck pain using manual therapy, it aims to enhance tissue extensibility, increase range of motion (ROM), mobilize soft tissue or joints, and reduce pain. Cervical mobilization has been shown to be an effective treatment for mechanical neck pain . conventional physical therapy will be in the form of: (superficial heat using hot pack for 10 minutes , Isometric Neck Exercises and Dynamic Neck
- 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, Amira Ebrahem Sadek, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07208396
- Sponsor's protocol ID
- P.T.REC/012/005854
- Acronym
- LSS
- Status last verified
- Sep 2025
- First submitted
- 24 Sep 2025
- Last updated
- 6 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- UPPER CERVICAL MOBILIZATION VERSUS INTEGRATED NEUROMUSCULAR INHIBITION TECHNIQUE IN PATIENTS WITH LEVATOR SCAPULAE SYNDROME
- ClinicalTrials.gov ID
- NCT07208396
- Acronym / sponsor ID
- LSS / P.T.REC/012/005854
- Conditions
- Levator Scapulae Syndrome
- Keywords
- trigger points
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Oct 2025 (estimated)
- Primary completion
- 5 Jun 2026 (estimated)
- Study completion
- 5 Jun 2026 (estimated)
- First posted
- 6 Oct 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 study will be conducted to answer the following research question: is there a difference between the effect of upper cervical mobilization and integrated neuromuscular inhibition technique of levator scapulae muscle in patients with levator scapulae syndrome?
Detailed description
Neck pain might be usually provoked by TrPs in the upper trapezius and levator scapulae muscles The differentiation in levator scapulae MTrPs prevalence between the right and left sides may also indicate potential asymmetries in muscle use or stress, which could be relevant for diagnosis and treatment strategies.
Integrated treatment approach (INIT) for neck pain provides greater pain relief, reduces disability, improves functional ability, and improves quality of life than other treatments Cervical Spine Mobilization (CSM) by oscillatory movements and traction to the cervical segments helps to break adhesion and stretch the hypo-mobile shortened structures.
There is a gap in the available literature about the comparative effect of upper cervical mobilization and integrated neuromuscular inhibition technique (INIT) of levator scapulae muscle on neck pain, neck disability, range of motion, and cervical proprioception in levator scapulae syndrome.
60 Participants recruited from both genders will be assigned randomly into 3 equal groups Group A : will receive upper cervical mobilization plus conventional treatment .
Group B : will receive integrated neuromuscular technique, It is a technique which combines three methods (Ischemic compression- muscle energy technique- strain counter strain) plus conventional treatment .
Group C : will receive conventional physical therapy only in the form of: (superficial heat using hot pack for 10 minutes ,Isometric Neck Exercises and Dynamic Neck) .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- The Integrated Neuromuscular Inhibition Technique (INIT) is an approach that combines three interventions: Ischemic Compression, Strain Counter Strain, and Muscle Energy Technique. INIT aims to stretch the fascia and muscle structures and increase muscle flexibility, prevent and eliminate taut bands/trigger points and adhesions on the fascia, eliminate complaints of pain and headaches, reduce stiffness, and improve functional abilities . Cervical mobilization is the common approach used by physical therapists to treat mechanical neck pain using manual therapy, it aims to enhance tissue extensibility, increase range of motion (ROM), mobilize soft tissue or joints, and reduce pain. Cervical mobilization has been shown to be an effective treatment for mechanical neck pain . conventional physical therapy will be in the form of: (superficial heat using hot pack for 10 minutes , Isometric Neck Exercises and Dynamic Neck
| Arm | Type | Receives |
|---|---|---|
| UPPER CERVICAL MOBILIZATION | Experimental | Other: Upper cervical mobilizationAll patients in group A will receive Grades I and II mobilizations and conventional physical therapy program in the form of :( hot pack, Dynamic and Isometric Neck Exercises) for four weeks. |
| Integrated neuromuscular inhibition technique | Experimental | Other: Integrated neuromuscular inhibition techniqueGroup B will receive integrated neuromuscular inhibition Technique and conventional physical therapy program as in group A in the form of :( hot pack, Dynamic and Isometric Neck Exercises) for four weeks. |
| conventional treatment | Active comparator | Other: Conventional treatmentParticipants in group C will receive conventional physical therapy only in the form of: (superficial heat using hot pack for 10 minutes, Dynamic Neck Exercises and Isometric Neck Exercises) for four weeks |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with a primary complaint of chronic neck pain (assessed by VAS) for more than 3 months.
- Subjects with pain provocation and reduced mobility at the upper cervical segment (assessed by passive accessory intervertebral movements (PAIVMs) and reduced mobility at cervical spine (assessed by CROM) will be included in the study.
- Participants will be recruited from both genders with age ranged from 18 to 45 years old, and BMI from 18 to 30kg/m2
Key exclusion criteria (1 listed)
- 1) Previous spine surgery 2) Pregnant and breast feeding women 3) Diabetic patients 4) Hypertensive patients 5) Neck pain associated with cervical radiculopathy 6) Whiplash injuries 7) Cervical spine fracture 8) Vertebrobasilar insufficiency. 9) Red flags suggesting of cancer, infection, vascular insufficiency
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 |
|---|---|---|
| Upper cervical mobilizationAll patients in group A will receive Grades I and II mobilizations in the first two sessions to reduce pain. In subsequent sessions, patients will receive Grades III and IV mobilizations; typically will be utilized to stretch the joint capsule and passive tissues, which provide stability to the joint, thereby increasing ROM. Maitland usually performs treatment techniques in an oscillatory manner. These oscillations can be performed with different amplitudes in different positions in the range of movement. The mobilizations will be delivered in the prone position. The duration of mobilization will be 30-s bouts given for three sets. The therapist places a hand dorsally at the level of the vertebral arch of C1 with the metacarpophalangeal and radial border of the index finger. The other hand will be placed posteriorly under the occiput, with the shoulder positioned anteriorly on the patient's forehead. The mobilization force will be directed dorsally from the shoulder until the therapist | Other | UPPER CERVICAL MOBILIZATION |
| Integrated neuromuscular inhibition techniqueAn integrated approach to myofascial trigger point release is achieved by combining several manual therapy techniques under the name INIT (Integrated Neuromuscular Inhibition Technique). The technique combines MET and SCS with ischemic compression in one coordinated technique . First, intermittent compression(IC) was initiated by using the thumb and index finger to apply a pincer grip to the TrP in the middle of the UT. Second, the strain counter strain (SCS) began by applying pressure to the trigger point . The participants' heads were passively flexed laterally to the affected side. and then asked the patient about pain. Third, the MET begins with one of the investigator's hands stabilizing the affected shoulder and the other on the head side. The participant was asked to move the stabilized shoulder and head in the direction of the other. This contraction lasted 7 seconds and had a maximum voluntary contraction of 20%. After that, the muscle was lengthened for 30 seconds | Other | Integrated neuromuscular inhibition technique |
| Conventional treatment1. Hot packs Hot pack will be applied at the beginning of the treatment session for all patients participated in the study. The participants will be in prone lying position. The neck and upper thoracic region will be exposed. The hot pack then will be applied for 10 minutes on cervical and upper thoracic region. 2. Dynamic neck exercise: Dynamic neck exercises include lifting head up with the chin tucked in from supine lying for neck flexion, lifting head backwards in prone lying for neck extension lifting head sideways from pillow in side lying position for neck side flexion which will be also repeated for the other side. 3. Isometric Neck Exercises The exercises will be performed in sitting position, by holding the theraband directly forwards for neck flexion, backwards for neck extension and obliquely towards right and left and by crossing over the band for neck side flexion and rotation. All these will be done for all patients participated in the study for about 5-10 repetition | Other | conventional treatment |
Primary outcome
pain pressure threshold of trigger points
Time frame: up to 4 weeks
The Pressure Pain Threshold (PPT) is defined as the point at which a non-painful pressure stimulus turns into a painful pressure sensation. Pressure algometry (PA) is a method described to objectify this PPT. This technique is a well-known and well-validated method to induce acute experimental pain. Different studies have been published about using this tool to evaluate pain in different locations of the body and showed high levels of reliability.
Measurement of Neck Functional Disability Level using the Arabic Version of Neck Disability Index
Time frame: up to 4 weeks
The patient will be relaxed and asked to complete the NDI before treatment and after treatment, which consists of 10 items. Each item is scored from zero (no disability) to five (total disability), with the maximum possible total score being 50. For each item, the subject asked to choose one answer that best defined his/her neck functional disability level. Scores for each item tallied and the total score will be recorded. Mean duration of the test: 3 to 7.8 minutes. Vernon and Mior presented the following interpretation
2 secondary outcomes
Measurement of cervical proprioception
Time frame: up to 4 weeks
Range of motion assessment of cervical spine
Time frame: up to 4 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 Oct 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.
Questions about this trial
What is this clinical trial studying?
A study testing Upper cervical mobilization, Integrated neuromuscular inhibition technique and Conventional treatment in people with Levator Scapulae Syndrome, 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 3 inclusion and 1 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 Oct 2025. 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 Amira E Sadek, master (01032808569, amerasadek21@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain pressure threshold of trigger points (time frame: up to 4 weeks). The study lists 2 primary outcomes in all. 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 Oct 2025.