Shoulder PainNCT06158568
Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain
A study testing Percutaneous Electrical Nerve Stimulation and Exercise in people with Shoulder Pain, run by César Fernández-de-las-Peñas at 1 site in Spain.
Trial summary
Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Percutaneous Electrical Nerve Stimulation and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 59 participants
- Where
- 1 siteSpain
- Study dates
- 1 Dec 2023to 27 Apr 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)
- Shoulder pain from at least 3 months
- Shoulder pain of more than 3/10 points on a NPRS
Who cannot join
- Bilateral shoulder symptoms
- Younger than 18 or older than 65 years
- History of shoulder traumatisms, fractures or dislocation
- Diagnosis of cervical radiculopathy or myelopathy
- Previous interventions with steroid injections in the shoulder area
- Comorbid medical conditions, e.g., fibromyalgia syndrome
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- Previous history of shoulder or neck surgery
- Any type of intervention for the neck-shoulder area during the previous year
- Fear to needles
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Percutaneous Electrical Nerve Stimulation and Exercise for Patients With Subacromial Pain Syndrome
Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.
Read the detailed description
Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.
- Conditions
- Shoulder Pain
- Being tested
- Percutaneous Electrical Nerve Stimulation, Placebo Percutaneous Electrical Nerve Stimulation, Exercise
- Keywords
- Neuromodulation, Percutaneous Nerve Stimulation, Exercise
- Medical subject headings
- Shoulder Pain, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Percutaneous Electrical Nerve StimulationOther
Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves
Placebo Percutaneous Electrical Nerve StimulationOther
Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves
ExerciseOther
Application of three weeks of progressive exercises targeting the shoulder musculature
| Study group | Role | What they receive |
|---|---|---|
| Percutaneous Electrical Nerve Stimulation | Experimental | Participants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks. Receives: Other: Percutaneous Electrical Nerve Stimulation; Other: Exercise |
| Placebo Percutaneous Nerve Stimulation | Placebo comparator | Participants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks. Receives: Other: Placebo Percutaneous Electrical Nerve Stimulation; Other: Exercise |
| Exercise | Active comparator | Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks. Receives: Other: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in disability between baseline and follow-up periods
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
Measured: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Secondary outcomes (3)
Changes in shoulder pain between baseline and follow-up periods
A 10-point Numerical Pain Rating Scale (NPRS; 0: no pain, 10: maximum pain) will be used to assess the patients' mean level of shoulder pain experienced in the preceding week in the shoulder area.
Measured: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Changes in sleep quality between baseline and follow-up periods
The Pittsburgh Sleep Quality Index (PSQI) will be used to evaluate the quality of sleep
Measured: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Changes in anxiety/depressive symptoms between baseline and follow-up periods
The Hospital Anxiety and Depression Scale (HADS, A: Anxiety; D: Depression) will be used to evaluate the presence of anxiety/depressive symptoms
Measured: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2023
- Study start1 Dec 2023
- Primary completion25 Jan 2024
- Study completion27 Apr 2024
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
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 59 participants (actual)
Sponsor and investigators
- Lead sponsor
- César Fernández-de-las-Peñas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, César Fernández-de-las-Peñas, Universidad Rey Juan Carlos
- Investigators
- César Fernández-de-las-Peñas, PhD, Principal investigator, Universidad Rey Juan Carlos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06158568
- Sponsor's protocol ID
- URJC0609202218622
- Status last verified
- Apr 2024
- First submitted
- 27 Nov 2023
- Last updated
- 30 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Percutaneous Electrical Nerve Stimulation and Exercise for Patients With Subacromial Pain Syndrome
- ClinicalTrials.gov ID
- NCT06158568
- Acronym / sponsor ID
- URJC0609202218622
- Conditions
- Shoulder Pain
- Keywords
- Neuromodulation, Percutaneous Nerve Stimulation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 59 participants (actual)
- Lead sponsor
- César Fernández-de-las-PeñasUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 25 Jan 2024 (actual)
- Study completion
- 27 Apr 2024 (actual)
- First posted
- 6 Dec 2023 (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.
Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.
Detailed description
Based on the available literature, application of percutaneous electrical nerve stimulation interventions targeting peripheral nerves (also called percutaneous neuromodulation) has shown positive effects for improving pain-related and functional outcomes in musculoskeletal chronic pain. Studies investigating the use of this intervention for the shoulder are lacking.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Percutaneous Electrical Nerve Stimulation | Experimental | Other: Percutaneous Electrical Nerve Stimulation, Other: ExerciseParticipants assigned to this group will received four sessions (once per week) of ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerves for 30 minutes. We will apply a biphasic compensated electrical current at a frequency of 2 Hz, a pulse width of 250 μs and intensity allowed over a pain-free motor threshold (muscle contraction). In addition, they will receive a program of exercises for the shoulder musculature for 3 weeks. |
| Placebo Percutaneous Nerve Stimulation | Placebo comparator | Other: Placebo Percutaneous Electrical Nerve Stimulation, Other: ExerciseParticipants assigned to this group will received four sessions (once per week) of placebo ultrasound guided percutaneous electrical nerve stimulation targeting the axillar and suprascapular nerve. The electrical current will be off and no electrical current will be provided to the patient. In addition, they will receive the same program of exercises for the shoulder than the experimental group for three weeks. |
| Exercise | Active comparator | Other: ExerciseParticipants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Unilateral non-traumatic shoulder pain (positive painful arc during shoulder abduction and a positive Hawkins test on clinical examination)
- Shoulder pain from at least 3 months
- Shoulder pain of more than 3/10 points on a NPRS
Key exclusion criteria (9 listed)
- Bilateral shoulder symptoms
- Younger than 18 or older than 65 years
- History of shoulder traumatisms, fractures or dislocation
- Diagnosis of cervical radiculopathy or myelopathy
- Previous interventions with steroid injections in the shoulder area
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 |
|---|---|---|
| Percutaneous Electrical Nerve StimulationApplication of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves | Other | Percutaneous Electrical Nerve Stimulation |
| Placebo Percutaneous Electrical Nerve StimulationApplication of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves | Other | Placebo Percutaneous Nerve Stimulation |
| ExerciseApplication of three weeks of progressive exercises targeting the shoulder musculature | Other | Exercise, Percutaneous Electrical Nerve Stimulation, Placebo Percutaneous Nerve Stimulation |
Primary outcome
Changes in disability between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 1 and 3 months after the intervention
The Disabilities of the Arm, Shoulder and Hand (DASH) will be used to determine the disability induced by shoulder pain
3 secondary outcomes
Changes in shoulder pain between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Changes in sleep quality between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 1 and 3 months after the intervention
Changes in anxiety/depressive symptoms between baseline and follow-up periods
Time frame: Baseline, one week after the last intervention and 1 and 3 months after the intervention
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 2024.
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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.
César Fernández-de-las-Peñas, PhD principal investigator
Universidad Rey Juan Carlos
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Percutaneous Electrical Nerve Stimulation and Exercise in people with Shoulder Pain, run by César Fernández-de-las-Peñas at 1 site in Spain.
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 3 inclusion and 9 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 2024. 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 Spain. 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. Some participants in this study may receive a placebo. 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?
Changes in disability between baseline and follow-up periods (time frame: Baseline, one week after the last intervention and 1 and 3 months after the intervention). 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 2024.