Shoulder PainNCT07559058
Perineural Injection Treatment for Shoulder Pain
A study testing Dextrose 5% Injection, Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise Program in people with Shoulder Pain and Rotator Cuff Disorders, run by Rizki Darmawan at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Shoulder Pain, Rotator Cuff Disorders, Adhesive Capsulitis
- What is being tested?
- Dextrose 5% Injection, Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise Program
- Type of treatment
- Injection or infusion, Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Oct 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the detailed description
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.
- Conditions
- Shoulder Pain, Rotator Cuff Disorders, Adhesive Capsulitis
- Being tested
- Dextrose 5% Injection, Transcutaneous Electrical Nerve Stimulation (TENS), Exercise Program
- Keywords
- Perineural Injection Treatment, PIT, Shoulder Pain, Transcutaneous Electrical Nerve Stimulation, TENS, Chronic Shoulder Pain, DASH Score, Numeric Rating Scale
- Medical subject headings
- Shoulder Pain, Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dextrose 5% InjectionDrug
A 5% dextrose solution is administered via subcutaneous perineural injection targeting painful peripheral nerve areas using a fine needle.
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.
Exercise ProgramBehavioural
A standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Transcutaneous Electrical Nerve Stimulation (TENS); Behavioral: Exercise Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline to 2 weeks
Secondary outcomes (1)
Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
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.
Measured: Baseline to 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2026
- Study start1 Oct 2025
- Primary completion31 Jan 2026
- Study completion31 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rizki Darmawan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Rizki Darmawan, Hasanuddin University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07559058
- Sponsor's protocol ID
- No.495/UN4.6.4.5.31/PP36/2025
- Status last verified
- Apr 2026
- First submitted
- 24 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Perineural Injection Treatment on Pain Intensity and Functional Outcomes in Patients With Shoulder Pain: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07559058
- Acronym / sponsor ID
- No.495/UN4.6.4.5.31/PP36/2025
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Rizki DarmawanUniversity, hospital or other
- Study start
- 1 Oct 2025 (actual)
- Primary completion
- 31 Jan 2026 (actual)
- Study completion
- 31 Jan 2026 (actual)
- First posted
- 30 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Perineural Injection Treatment (PIT) | Experimental | Drug: Dextrose 5% Injection, Behavioral: Exercise ProgramParticipants 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. |
| Transcutaneous Electrical Nerve Stimulation (TENS) | Active comparator | Device: Transcutaneous Electrical Nerve Stimulation (TENS), Behavioral: Exercise ProgramParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dextrose 5% InjectionA 5% dextrose solution is administered via subcutaneous perineural injection targeting painful peripheral nerve areas using a fine needle. | Drug | Perineural Injection Treatment (PIT) |
| Transcutaneous Electrical Nerve Stimulation (TENS)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. | Device | Transcutaneous Electrical Nerve Stimulation (TENS) |
| Exercise ProgramA standardized exercise program including active range of motion, stretching, and strengthening exercises using elastic resistance bands. | Behavioural | Perineural Injection Treatment (PIT), Transcutaneous Electrical Nerve Stimulation (TENS) |
Primary outcome
Change in Pain Intensity Measured by Numeric Rating Scale (NRS)
Time frame: 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.
1 secondary outcome
Change in Functional Status Measured by Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: Baseline to 2 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Shoulder Pain
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Effects of Cervicothoracic Mobilization in Patients With Supraspinatus Tendinitis
Rotator Cuff Tendonitis
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Hybrid mHealth and Telerehabilitation vs Conventional Physiotherapy for Subacromial Pain Syndrome
Subacromial Pain Syndrome
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Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Active, not recruiting
Effects of Injection Combined With Spencer Technique on Painful Frozen Shoulder
Frozen Shoulder
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Hemiplegic Shoulder Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dextrose 5% Injection, Transcutaneous Electrical Nerve Stimulation (TENS) and Exercise Program in people with Shoulder Pain and Rotator Cuff Disorders, run by Rizki Darmawan at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Intensity Measured by Numeric Rating Scale (NRS) (time frame: Baseline to 2 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.