Perineural Injection Treatment for Shoulder Pain

NCT07559058 | Completed

• 1 other identifier: No.495/UN4.6.4.5.31/PP36/2025
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Shoulder Pain; Rotator Cuff Disorders; Adhesive Capsulitis

Keywords

Perineural Injection Treatment; PIT; Shoulder Pain; Transcutaneous Electrical Nerve Stimulation; TENS; Chronic Shoulder Pain; DASH Score; Numeric Rating Scale

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured by Numeric Rating Scale (NRS)

  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

Secondary Outcomes (1)

• Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)

  Baseline to 2 weeks

Study Arms (2)

Perineural Injection Treatment (PIT)

EXPERIMENTAL

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.

Drug: Dextrose 5% Injection; Behavioral: Exercise Program

Transcutaneous Electrical Nerve Stimulation (TENS)

ACTIVE COMPARATOR

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.

Device: Transcutaneous Electrical Nerve Stimulation (TENS); Behavioral: Exercise Program

Interventions

Dextrose 5% Injection DRUG

A 5% dextrose solution is administered via subcutaneous perineural injection targeting painful peripheral nerve areas using a fine needle.

Perineural Injection Treatment (PIT)

Transcutaneous Electrical Nerve Stimulation (TENS) DEVICE

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.

Transcutaneous Electrical Nerve Stimulation (TENS)

Exercise Program BEHAVIORAL

A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.

Perineural Injection Treatment (PIT); Transcutaneous Electrical Nerve Stimulation (TENS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rizki Darmawan: lead

Study Sites (1)

Hasanuddin University Hospital

Makassar, Indonesia

Location

MeSH Terms

Conditions

Shoulder Pain; Bursitis

Interventions

Glucose; Injections; Transcutaneous Electric Nerve Stimulation; Resistance Training

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hexoses; Monosaccharides; Sugars; Carbohydrates; Drug Administration Routes; Drug Therapy; Therapeutics; Electric Stimulation Therapy; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Exercise Therapy; Aftercare; Continuity of Patient Care; Patient Care; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MD

Model Details: Participants are randomly assigned to one of two parallel groups: Perineural Injection Treatment (PIT) or Transcutaneous Electrical Nerve Stimulation (TENS). Both groups receive a standardized exercise program.

Study Record Dates

• First Submitted: April 24, 2026
• First Posted: April 30, 2026
• Study Start: October 1, 2025
• Primary Completion: January 31, 2026
• Study Completion: January 31, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Locations

ID (1)