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Perineural Injection Treatment for Shoulder Pain

24 de abril de 2026 actualizado por: Rizki Darmawan

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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Actual)

32

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Makassar, Indonesia
        • Hasanuddin University Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Descripción

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 de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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.
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.
Comparador activo: 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.
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Periodo de tiempo: Baseline to 2 weeks
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.
Baseline to 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
Periodo de tiempo: 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.
Baseline to 2 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de octubre de 2025

Finalización primaria (Actual)

31 de enero de 2026

Finalización del estudio (Actual)

31 de enero de 2026

Fechas de registro del estudio

Enviado por primera vez

24 de abril de 2026

Primero enviado que cumplió con los criterios de control de calidad

24 de abril de 2026

Publicado por primera vez (Actual)

30 de abril de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

30 de abril de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

24 de abril de 2026

Última verificación

1 de abril de 2026

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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