- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07599631
Integrated Neuromuscular Inhibition Technique Versus Instrument-Assisted Soft Tissue Mobilization On Neck Disability, Endurance, and Proprioception Of Nonspecific Chronic Neck Pain (CNP)
14 maj 2026 uppdaterad av: 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
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Beräknad)
60
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Nabil Abdel-Aal, professor
- Telefonnummer: 01200133613
- E-post: nabil.mahmoud@cu.edu.eg
Studera Kontakt Backup
- Namn: haidy fouad, phd
- Telefonnummer: 0 12 23848175
- E-post: haidyfouad1989@gmail.com
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Nej
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: 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
|
|
Experimentell: 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.
|
|
Aktiv komparator: 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
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
neck disability
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
pain intensity
Tidsram: 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
Tidsram: 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)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
25 maj 2026
Primärt slutförande (Beräknad)
25 maj 2027
Avslutad studie (Beräknad)
25 maj 2027
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
14 maj 2026
Första postat (Faktisk)
20 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
20 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- P.T.REC/012/006464
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