- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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.
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Makassar, Indonesia
- Hasanuddin University Hospital
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Kuvaus
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
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: 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.
|
|
Active Comparator: 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.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Aikaikkuna: 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.
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Baseline to 2 weeks
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
Aikaikkuna: 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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Kipu
- Neurologiset ilmenemismuodot
- Tuki- ja liikuntaelinten sairaudet
- Nivelsairaudet
- Nivelkipu
- Patologiset tilat, merkit ja oireet
- Merkit ja oireet
- Bursiitti
- Olkapääkipu
- Moottoritoiminta
- Liike
- Tuki- ja liikuntaelinten fysiologiset ilmiöt
- Tuki- ja hermosto- ja hermostofysiologiset ilmiöt
- Terapeuttiset lääkkeet
- Lämpötilahallinnon reitit
- Lääkehoito
- Fysioterapiatapa
- Hiilihydraatit
- Potilashoito
- Liikuntahoito
- Kuntoutus
- Jälkihoito
- Potilaan hoidon jatkuvuus
- Anestesia ja kipulääke
- Sokerit
- Fyysinen ilmastointi, ihminen
- Käyttää
- Sähköstimulaatioterapia
- Kipulääke
- Heksaosit
- Monosakkaridit
- Injektiot
- Vastusharjoittelu
- Sisäinen sähköhermon stimulaatio
- Glukoosi
Muut tutkimustunnusnumerot
- No.495/UN4.6.4.5.31/PP36/2025
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