- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07694102
Effect of Integrated Neuromuscular Inhibition Technique on Patients With Non-Specific Neck Pain (INIT-Neck)
Non-specific mechanical neck pain (NSNP) is a common musculoskeletal condition that causes neck pain, reduced movement, and difficulty performing daily activities. Manual therapy techniques are frequently used to manage this condition; however, evidence regarding the combined use of Integrated Neuromuscular Inhibition Technique (INIT) and cervical mobilization remains limited.
This randomized controlled trial aims to compare the effectiveness of INIT combined with cervical mobilization versus cervical mobilization with conventional physiotherapy in adults with non-specific mechanical neck pain. Forty-two participants aged 30-60 years will be allocated to one of two treatment groups. The experimental group will receive INIT, consisting of muscle energy technique, strain-counterstrain, and ischemic compression, in addition to cervical mobilization. The control group will receive cervical mobilization with conventional physiotherapy modalities. Both groups will receive five treatment sessions.
The primary outcomes are pain intensity, neck-related disability, and cervical range of motion. Outcomes will be assessed before treatment and after completion of the intervention using the Numeric Pain Rating Scale (NPRS), Neck Disability Index (NDI), and cervical range of motion measurements. The findings of this study are expected to determine whether adding INIT to cervical mobilization provides greater improvements in pain, cervical mobility, and functional ability than conventional physiotherapy alone, thereby supporting evidence-based management of non-specific mechanical neck pain.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Non-specific mechanical neck pain (NSNP) is one of the most prevalent musculoskeletal disorders worldwide and is associated with pain, reduced cervical mobility, functional limitations, decreased work productivity, and impaired quality of life. The condition is commonly related to myofascial trigger points, altered neuromuscular control, muscle imbalance, postural dysfunction, and restricted cervical joint mobility. Although conventional physiotherapy, including electrotherapy and cervical mobilization, has demonstrated beneficial effects, many patients continue to experience persistent symptoms and recurrent episodes.
Integrated Neuromuscular Inhibition Technique (INIT) is a multimodal manual therapy approach that combines muscle energy technique (MET), strain-counterstrain, and ischemic compression to address both myofascial and neuromuscular dysfunction. These techniques are intended to reduce pain, deactivate myofascial trigger points, improve muscle extensibility, restore neuromuscular control, and increase cervical range of motion. Previous studies have demonstrated promising results for INIT; however, evidence regarding its effectiveness when combined with cervical mobilization remains limited.
This study is a prospective, randomized, parallel-group controlled trial conducted at the Physiotherapy Outpatient Department of Fauji Foundation Hospital, Rawalpindi, Pakistan. Forty-two participants diagnosed with non-specific mechanical neck pain will be allocated equally to either an experimental group receiving INIT combined with cervical mobilization or a control group receiving cervical mobilization with conventional physiotherapy. Each participant will complete five treatment sessions.
The primary outcome measures include pain intensity assessed using the Numeric Pain Rating Scale (NPRS), neck-related disability assessed using the Neck Disability Index (NDI), and cervical range of motion measured with a universal goniometer. Assessments will be performed at baseline and immediately after completion of the treatment protocol.
The study aims to determine whether the addition of INIT to cervical mobilization results in superior improvements in pain, cervical mobility, and functional disability compared with conventional physiotherapy. The findings are expected to provide high-quality evidence regarding the clinical effectiveness of this multimodal manual therapy approach and may contribute to improving rehabilitation strategies and clinical practice guidelines for the management of non-specific mechanical neck pain.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Islamabad, Pakistan, 44800
- Physical Medicine and Rehabilitation Department, Fauji Foundation Hospital
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 30 to 60 years.
- Clinical diagnosis of non-specific mechanical neck pain.
- Neck pain duration of less than 6 months.
- Painful cervical extension and rotation.
- Negative Sharp-Purser test.
- Negative vertebral artery insufficiency test.
- No history of whiplash injury.
- Able and willing to provide written informed consent and comply with the study protocol
Exclusion Criteria:
- Specific causes of neck pain (e.g., fracture, infection, tumor, inflammatory disease, or cervical myelopathy).
- History of cervical spine surgery.
- Positive Sharp-Purser test or vertebral artery insufficiency test.
- History of whiplash injury.
- Neurological disorders affecting the cervical spine or upper extremities.
- Pregnancy.
- Receipt of physiotherapy or manual therapy for neck pain within the previous 4 weeks.
- Any medical condition that would prevent safe participation in the intervention or outcome assessment.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Integrated Neuromuscular Inhibition Technique + Cervical Mobilization
Participants receive the Integrated Neuromuscular Inhibition Technique (muscle energy technique, strain-counterstrain, and ischemic compression) combined with cervical mobilization and conventional physiotherapy for five treatment sessions.
|
Integrated Neuromuscular Inhibition Technique (INIT) is a multimodal manual therapy consisting of Muscle Energy Technique (MET), Strain-Counterstrain (SCS), and Ischemic Compression (IC).
The intervention targets myofascial trigger points, muscle tightness, and neuromuscular dysfunction to reduce pain, improve cervical range of motion, and decrease functional disability.
Participants received INIT in combination with cervical mobilization during five treatment sessions.
Cervical mobilization was performed using Maitland mobilization techniques applied to the cervical spine (C1-C7) to improve joint mobility, reduce pain, and restore cervical range of motion.
Mobilization was administered in three sets of ten repetitions during each of the five treatment sessions.
This intervention was provided to participants in both study groups.
|
|
Comparateur actif: Conventional Physiotherapy + Cervical Mobilization
Participants receive cervical mobilization together with conventional physiotherapy, including TENS and hot pack therapy, for five treatment sessions.
|
Cervical mobilization was performed using Maitland mobilization techniques applied to the cervical spine (C1-C7) to improve joint mobility, reduce pain, and restore cervical range of motion.
Mobilization was administered in three sets of ten repetitions during each of the five treatment sessions.
This intervention was provided to participants in both study groups.
Conventional physiotherapy consisted of transcutaneous electrical nerve stimulation (TENS) applied for 15 minutes and hot pack therapy applied to the cervical and upper back region for 10-15 minutes.
These modalities were provided together with cervical mobilization during each of the five treatment sessions.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Pain Intensity
Délai: Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
Pain intensity will be assessed using the Numeric Pain Rating Scale (NPRS), an 11-point validated scale ranging from 0 (no pain) to 10 (worst imaginable pain).
Lower scores indicate reduced pain intensity.
|
Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
|
Neck-Related Disability
Délai: Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
Neck-related disability will be evaluated using the Neck Disability Index (NDI), a validated 10-item questionnaire with total scores ranging from 0 to 50.
Higher scores indicate greater disability, while lower scores indicate improvement in functional status.
|
Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
|
Cervical Range of Motion
Délai: Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
Active cervical extension and rotation will be measured using a universal goniometer.
Changes in cervical range of motion will be compared between groups to evaluate improvements in cervical mobility following the intervention.
|
Baseline and immediately after completion of five treatment sessions (approximately 1 week).
|
Collaborateurs et enquêteurs
Collaborateurs
Les enquêteurs
- Chercheur principal: Dr Hafiz Masood Ahmad Tahir, MSPT, Fauji Foundation Hospital
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- RIPHAH/RCRS/REC/Letter-00410
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .