- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07559058
Perineural Injection Treatment for Shoulder Pain
Effect of Perineural Injection Treatment on Pain Intensity and Functional Outcomes in Patients With Shoulder Pain: A Randomized Controlled Trial
Shoulder pain is a common musculoskeletal condition that can lead to significant functional limitation and reduced quality of life. Conventional treatments often provide limited or temporary relief, highlighting the need for alternative approaches targeting peripheral pain mechanisms.
This study aims to evaluate the effectiveness of Perineural Injection Treatment (PIT) compared to Transcutaneous Electrical Nerve Stimulation (TENS) in reducing pain and improving functional outcomes in patients with subacute or chronic shoulder pain.
In this randomized controlled trial, participants are assigned to receive either PIT or TENS, in addition to a standardized exercise program. The intervention is delivered over two sessions within a two-week period. Pain intensity is assessed using the Numeric Rating Scale (NRS), and functional outcomes are measured using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire.
The results of this study are expected to provide evidence on the comparative effectiveness of PIT and TENS, and to support clinical decision-making in the management of shoulder pain.
Aperçu de l'étude
Statut
Les conditions
Description détaillée
Shoulder pain is one of the most prevalent musculoskeletal disorders and is associated with substantial disability and reduced quality of life. The etiology is multifactorial, involving structures such as the rotator cuff, glenohumeral joint, and surrounding soft tissues. In addition to nociceptive mechanisms, neuropathic and nociplastic components may contribute to persistent pain, making management challenging.
Conventional treatments, including pharmacological therapy, physical therapy, and injection-based interventions, have shown variable effectiveness and may provide only short-term relief. Therefore, there is increasing interest in minimally invasive interventions that target peripheral sensitization.
Perineural Injection Treatment (PIT) is a therapeutic approach involving subcutaneous injection of low-concentration dextrose solution along peripheral nerve pathways. It is proposed to reduce neurogenic inflammation and modulate nociceptor activity, potentially leading to improved pain and function. However, evidence regarding its effectiveness in shoulder pain remains limited.
This study is designed as a single-blind randomized controlled trial comparing PIT with Transcutaneous Electrical Nerve Stimulation (TENS) in patients with subacute or chronic shoulder pain. A total of 32 participants are randomly assigned to either the PIT group or the TENS group. Both groups receive a standardized exercise program, including active range of motion, stretching, and strengthening exercises.
The intervention consists of two treatment sessions administered over a two-week period. PIT is performed using subcutaneous injections of 5% dextrose along painful peripheral nerve areas. TENS is applied using conventional parameters with frequency 75-100 Hz and pulse width less than 200 microseconds.
Outcome measures include pain intensity assessed using the Numeric Rating Scale (NRS) and functional status evaluated using the Disabilities of the Arm, Shoulder, and Hand (DASH) questionnaire. Assessments are conducted at baseline, immediately after intervention, and at the end of the intervention period.
The primary objective of this study is to evaluate the effectiveness of PIT in reducing pain intensity compared to TENS. Secondary objectives include assessing functional improvement and immediate analgesic effects following intervention.
The findings of this study are expected to contribute to evidence-based management of shoulder pain and support the use of mechanism-based interventions targeting peripheral nociceptive pathways.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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Makassar, Indonésie
- Hasanuddin University Hospital
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- Adults aged 18-65 years
- Patients with subacute or chronic shoulder pain
- Pain intensity ≥ 3 on the Numeric Rating Scale (NRS)
- Diagnosed with shoulder conditions such as adhesive capsulitis, rotator cuff tendinopathy or tear, glenohumeral osteoarthritis, acromioclavicular joint sprain, or biceps tendinopathy
- Able to provide informed consent
Exclusion Criteria:
- History of injection therapy or use of analgesic medications within one week prior to intervention
- Presence of neurological or systemic diseases affecting upper limb function
- Pregnancy
- Contraindications to injection therapy (e.g., infection at injection site, needle phobia, allergy to dextrose)
- Refusal to participate or inability to complete the study protocol
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: Perineural Injection Treatment (PIT)
Participants receive perineural injection treatment using 5% dextrose administered subcutaneously along painful peripheral nerve areas.
The intervention is delivered in two sessions over a two-week period.
All participants also receive a standardized exercise program.
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A 5% dextrose solution is administered via subcutaneous perineural injection targeting painful peripheral nerve areas using a fine needle.
A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.
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|
Comparateur actif: Transcutaneous Electrical Nerve Stimulation (TENS)
Participants receive transcutaneous electrical nerve stimulation (TENS) using conventional parameters, along with a standardized exercise program.
The intervention is delivered in two sessions over a two-week period.
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A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.
TENS is applied using conventional mode with a frequency of 75-100 Hz and pulse width less than 200 microseconds, delivered for approximately 20 minutes per session.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Délai: Baseline to 2 weeks
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Pain intensity is assessed using the Numeric Rating Scale (NRS), ranging from 0 (no pain) to 10 (worst imaginable pain).
The outcome is defined as the change in NRS score from baseline to the end of the intervention period.
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Baseline to 2 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
Délai: Baseline to 2 weeks
|
Functional status is assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire, with scores ranging from 0 to 100, where lower scores indicate better function.
The outcome is defined as the change in DASH score from baseline to the end of the 2-week intervention period.
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Baseline to 2 weeks
|
Collaborateurs et enquêteurs
Parrainer
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
Termes MeSH pertinents supplémentaires
- La douleur
- Manifestations neurologiques
- Maladies musculo-squelettiques
- Maladies articulaires
- Arthralgie
- Conditions pathologiques, signes et symptômes
- Signes et symptômes
- Bursite
- Mal d'épaule
- Activité motrice
- Mouvement
- Phénomènes physiologiques musculo-squelettiques
- Phénomènes physiologiques musculo-squelettiques et neuronaux
- Thérapeutique
- Voies d'administration du médicament
- Pharmacothérapie
- Modalités de physiothérapie
- Glucides
- Soins aux patients
- Thérapie d'exercice
- Réhabilitation
- Suivi
- Continuité des soins aux patients
- Anesthésie et analgésie
- Sucre
- Conditionnement physique, humain
- Exercice
- Thérapie de stimulation électrique
- Analgésie
- Hexoses
- Monosaccharides
- Injections
- Formation en résistance
- Stimulation du nerf électrique transcutané
- Glucose
Autres numéros d'identification d'étude
- No.495/UN4.6.4.5.31/PP36/2025
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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