Percutaneous Electrical Nerve Stimulation and Exercise for Shoulder Pain

NCT ID: NCT06158568

Last Updated: 2024-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

59 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-01

Study Completion Date

2024-04-27

Brief Summary

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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

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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

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Percutaneous Electrical Nerve Stimulation

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.

Group Type EXPERIMENTAL

Percutaneous Electrical Nerve Stimulation

Intervention Type OTHER

Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves

Exercise

Intervention Type OTHER

Application of three weeks of progressive exercises targeting the shoulder musculature

Placebo Percutaneous Nerve Stimulation

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.

Group Type PLACEBO_COMPARATOR

Placebo Percutaneous Electrical Nerve Stimulation

Intervention Type OTHER

Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves

Exercise

Intervention Type OTHER

Application of three weeks of progressive exercises targeting the shoulder musculature

Exercise

Participants assigned to this group will receive the same program of exercises for the shoulder than the remaining groups for three weeks.

Group Type ACTIVE_COMPARATOR

Exercise

Intervention Type OTHER

Application of three weeks of progressive exercises targeting the shoulder musculature

Interventions

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Percutaneous Electrical Nerve Stimulation

Application of a electrical current percutaneously (at the motor response intensity) targeting the suprascapular and axillar nerves

Intervention Type OTHER

Placebo Percutaneous Electrical Nerve Stimulation

Application of sham electrical current (no intensity) percutaneously targeting the suprascapular and axillar nerves

Intervention Type OTHER

Exercise

Application of three weeks of progressive exercises targeting the shoulder musculature

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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
* Previous history of shoulder or neck surgery
* Any type of intervention for the neck-shoulder area during the previous year
* Fear to needles
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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César Fernández-de-las-Peñas

OTHER

Sponsor Role lead

Responsible Party

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César Fernández-de-las-Peñas

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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César Fernández-de-las-Peñas, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Rey Juan Carlos

Locations

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César Fernández-de-las-Peñas

Madrid, Rest of the World, Spain

Site Status

Countries

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Spain

Other Identifiers

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URJC0609202218622

Identifier Type: -

Identifier Source: org_study_id

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