- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07599631
Integrated Neuromuscular Inhibition Technique Versus Instrument-Assisted Soft Tissue Mobilization On Neck Disability, Endurance, and Proprioception Of Nonspecific Chronic Neck Pain (CNP)
14 maggio 2026 aggiornato da: Nabil Mahmoud Ismail Abdel-Aal, Cairo University
this study will be conducted to compare INIT versus IASTM on neck disability, cervical muscle endurance and proprioception, cervical alignment, pain intensity, pressure pain threshold in patients with neck pain
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Descrizione dettagliata
Neck pain arises from a variety of factors, which may include ergonomic considerations and individual characteristics such as age, behavioral attitudes, or psychosocial issues like anxiety and job satisfaction.
Since most cases of neck pain do not have a specific identifiable cause and are often linked to posture or mechanical issues, they are typically classified as nonspecific chronic neck pain.
The primary goals of treating neck pain and MTrPs are to resolve the spasm, ease the pain, and deactivate the TrPs.
One of these methods is the integrated neuromuscular inhibition technique (INIT).
Instrument-assisted soft tissue mobilization (IASTM) with the M2T blade (M2T-Blade: IASTM Technology, Hamilton, ON, Canada) is a multifunctional instrument.
Instrument-assisted soft tissue mobilization is inexpensive and has a variety of planes that can be used in treatment.
Many studies have demonstrated its effectiveness in alleviating patients' symptoms.According to the literature, IASTM and INIT were effective as well as nonexhaustive treatment methods for patients experiencing mechanical neck pain.
But there was a lack of literature that compared IASTM and INIT on neck disability, endurance, and proprioception on patients with neck pain.
Tipo di studio
Interventistico
Iscrizione (Stimato)
60
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Nabil Abdel-Aal, professor
- Numero di telefono: 01200133613
- Email: nabil.mahmoud@cu.edu.eg
Backup dei contatti dello studio
- Nome: haidy fouad, phd
- Numero di telefono: 0 12 23848175
- Email: haidyfouad1989@gmail.com
Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
No
Descrizione
Inclusion Criteria:
- All participants ages will range from 18 to 50 years.
- BMI ranged from 18.5 to 30.
- have TrPs in their UT muscle, pain at rest, a jump sign when pressure is applied, limited range of motion (ROM), and referred pain.
- The participants will report pain in the posterior or posterior lateral aspect of the neck in the previous 3 months
Exclusion Criteria:
- Participants of cervical spine disorders (cervical disc disease, cervical spondylitis, cervical myelopathy.
- Participants with musculoskeletal conditions.
- Pregnant women.
- Participants with congenital postural deformities.
- Participants who had a definite visual disability.
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Integrated Neuromuscular Inhibition Technique
twenty patients will receive the integrated neuromuscular inhibition technique plus traditional therapy three times a week for four weeks
|
For the integrated neuromuscular inhibition technique, the participant will be in a supine lying position.
During the PPT evaluation process, the site of the TrP will be determined and will be marked.
First, intermittent IC will be initiated by using the thumb and index finger to apply a pincer grip to the TrP in the middle of the UT.
Second, applying pressure to the trigger point and asking the participants how much pain they will experience.
The participants' heads will passively flexed laterally to the affected side.
The therapist then will hold the participant's forearm and passively will move the shoulder to about 90° of abduction while monitoring the discomfort induced by the TrP, and then will ask the patient about the intensity of pain.
If the pain will decrease by 70% from the start, the position will be held for 30 seconds and repeated 2 to 3 times.
Then muscle energy technique is applied plus tradional therapy.
the patients will receive tradional therapy in the form of 10 minutes of moist heat (hot pack) isometric strengthening exercises for all cervical muscles by applying manual resistance on the side of the head for side bending, the occiput for extension, and the forehead for flexion.The resistance will be sustained for 10 seconds and repeated 10 to 15 times, then they will receive stretching exercises for extensor muscles for 30 seconds and repeated 3 times in every session.
Finally, active ROM exercises for the neck and chin will be performed
|
|
Sperimentale: Instrument-Assisted Soft Tissue Mobilization
twenty patients will receive instrument-assisted soft tissue mobilization plus traditional therapy three times a week for four weeks
|
the patients will receive tradional therapy in the form of 10 minutes of moist heat (hot pack) isometric strengthening exercises for all cervical muscles by applying manual resistance on the side of the head for side bending, the occiput for extension, and the forehead for flexion.The resistance will be sustained for 10 seconds and repeated 10 to 15 times, then they will receive stretching exercises for extensor muscles for 30 seconds and repeated 3 times in every session.
Finally, active ROM exercises for the neck and chin will be performed
For IASTM, the M2T blade will be used to identify specific parts of the limitation on the right UT.
After that, treatment planes 1-2-3 will be used.
Prior to treatment, Vaseline will be applied as a lubricant to the skin around the neck area, and an alcohol pad will be used to clean the instrument.
Then, using an M2T blade at a 45° angle, long, slow strokes over the muscle will be performed, beginning at its insertion and ending at its origin, for 2 to 3 minutes .
If the participant felt a burning sensation, it will be instructed to apply an ice pack plus tradional therapy.
|
|
Comparatore attivo: traditional therapy
twenty patients will receive traditional therapy three times a week for four weeks
|
the patients will receive tradional therapy in the form of 10 minutes of moist heat (hot pack) isometric strengthening exercises for all cervical muscles by applying manual resistance on the side of the head for side bending, the occiput for extension, and the forehead for flexion.The resistance will be sustained for 10 seconds and repeated 10 to 15 times, then they will receive stretching exercises for extensor muscles for 30 seconds and repeated 3 times in every session.
Finally, active ROM exercises for the neck and chin will be performed
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
neck disability
Lasso di tempo: up to four weeks
|
The arabic version of Neck Disability Index (NDI) will be used.
it is a 10-item, self-administered questionnaire measuring neck pain-related disability, with scores ranging from 0-50 or 0-100%.
Higher scores indicate greater disability.
|
up to four weeks
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
pain intensity
Lasso di tempo: up to four weeks
|
visual analogue scale will be used to assess pain intensity.
The most simple VAS is a straight horizontal line of fixed length, usually 100 mm.
The ends are defined as the extreme limits of the parameter to be measured (symptom , pain ,health) orientated from the left (worst) to the right (best).
|
up to four weeks
|
|
cervical range of motion
Lasso di tempo: up to four weeks
|
cervical range of motion device will be used to assess cervical range of motion
|
up to four weeks
|
|
joint position error (cervical proprioception)
Lasso di tempo: up to four weeks
|
Proprioception is the ability to sense the position and movement of our body without visual feedback.
The cervical spine works as a sensory system that relies heavily on mechanoreceptors, like muscle spindles, that detect mechanical changes within tissue.
cervical proprioception will be measured by cervical range of motion device.
|
up to four weeks
|
|
pressure pain threshold
Lasso di tempo: up to four weeks
|
pressure algometer device will be used to assess pressure pain threshold
|
up to four weeks
|
|
The Absolute Rotation Angle (ARA) C2-C7
Lasso di tempo: up to four weeks
|
The Absolute Rotation Angle (ARA) C2-C7 is a key measurement of sagittal cervical lordosis on standing lateral radiographs, typically calculated as the angle between the inferior endplates of C2 and C7.
A normal range often falls between 10° and 35°.
C2-C7 Cobb angle (measured differently, from C2 inferior endplate to C7 inferior endplate).
Kinovea software will be used to assess ARA.
|
up to four weeks
|
|
The relative rotation angle between the occiput (C0) and C2
Lasso di tempo: up to four weeks
|
The relative rotation angle between the occiput (C0) and C2 is a critical metric for evaluating upper cervical spine mobility and stability.
In healthy individuals, the average O-C2 angle (often reported as the O-C2 angle or OC2A) is approximately 14.5° ± 3.7°.
this angle will be measured by Kinovea software.
|
up to four weeks
|
|
relative rotatory angle between c1 and c2
Lasso di tempo: up to four weeks
|
This angle between the axis and the atlas.
The normal range is 29 degree.
this angle will be measured by kinovea softwear.
|
up to four weeks
|
|
Anterior head translation (AHT) distance
Lasso di tempo: up to four weeks
|
Anterior head translation (AHT), or forward head posture, is typically measured as the horizontal distance between the vertical line of the C7 spinous process and the posterior superior corner of the C2 vertebra (or tragus of the ear).
A normal head position generally shows an anterior displacement of less than 15 mm, while values exceeding this are classified as forward head posture.this
disatance will be measured by kinovea softwear.
|
up to four weeks
|
|
deep cervical flexor endurance
Lasso di tempo: up to four weeks
|
cranio cervical flexion test with pressure biofeedback will be used to assess deep cervical flexor endurance.During the CCF test, the pressure biofeedback instrument was placed under the neutral cervical spine below the occiput and inflated up to 20 mmHg.
CCF (gentle head nodding of head as if saying "yes") movements were demonstrated during the test.
Substitution with superficial neck flexors, head retraction.
The subjects performed this movement at 5 different pressure levels, i.e., 22, 24, 26, 28, and 30 mmHg, with 30 s rest between each repetition.
Each level was supposed to be held for 10 s, and the test was terminated if they were unable to hold the position for 10 s at any level or if the maximum level was achieved (30 mmHg).
This value was used to create an index to score the muscle endurance out of a total of 100, and the minimum requirement for satisfactory endurance was 26 mmHg
|
up to four weeks
|
Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
25 maggio 2026
Completamento primario (Stimato)
25 maggio 2027
Completamento dello studio (Stimato)
25 maggio 2027
Date di iscrizione allo studio
Primo inviato
14 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
14 maggio 2026
Primo Inserito (Effettivo)
20 maggio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
20 maggio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
14 maggio 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- P.T.REC/012/006464
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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