NCT07208396

Brief 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?

Trial Health

65
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
1mo left

Started Oct 2025

Shorter than P25 for not_applicable

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress88%
Oct 2025Jun 2026

First Submitted

Initial submission to the registry

September 24, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

October 6, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 5, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 5, 2026

Last Updated

October 6, 2025

Status Verified

September 1, 2025

Enrollment Period

8 months

First QC Date

September 24, 2025

Last Update Submit

September 27, 2025

Conditions

Keywords

trigger points

Outcome Measures

Primary Outcomes (2)

  • 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.

    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

    up to 4 weeks

Secondary Outcomes (2)

  • Measurement of cervical proprioception

    up to 4 weeks

  • Range of motion assessment of cervical spine

    up to 4 weeks

Study Arms (3)

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.

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.

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

Other: Conventional treatment

Interventions

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

UPPER CERVICAL MOBILIZATION

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

Integrated neuromuscular inhibition technique

1. 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

conventional treatment

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • \) 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Central Study Contacts

Amira E Sadek, master

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principle investigator

Study Record Dates

First Submitted

September 24, 2025

First Posted

October 6, 2025

Study Start

October 20, 2025

Primary Completion (Estimated)

June 5, 2026

Study Completion (Estimated)

June 5, 2026

Last Updated

October 6, 2025

Record last verified: 2025-09