Percutaneous Electrical Nerve Stimulation Compared to Passive Assisted Neurodynamics in Brachial Plexus Neuropathy

NCT ID: NCT05432973

Last Updated: 2022-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2023-01-01

Brief Summary

Brachial plexus neuropathies, specifically of the median, radial, ulnar, suprascapular, axillary and dorsal scapular nerves, can arise when a peripheral nerve trunk or nerve root is subjected to injury, compression, inflammation or ischemia, resulting in reduced physical capabilities of the peripheral nervous system. Although pharmacological treatments provide mild symptomatic relief in the short term, they are not without side effects.

Neurostimulation techniques may be an effective treatment option for peripheral brachial plexus neuropathies. Some of these procedures are transcutaneous electrical nerve stimulation (TENS) or percutaneous electrical nerve stimulation (PENS). Although some case series have documented a positive effect in relation to ultrasound-guided PENS for subjects with subacromial pain syndrome or postsurgical pain, the lack of studies, to our knowledge, analyzing the effects of percutaneous electrical nerve stimulation, in relation to pain and paresthesias in subjects with brachial plexus neuropathy, warrants investigation for this goal.

Conditions

Percutaneous Electrical Nerve Stimulation; Peripheral Neuropathy; Neuropathic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

PENS

Group Type: EXPERIMENTAL

Percutaneous Electrical Nerve Stimulation

Intervention Type: PROCEDURE

In the PENS treatment, a biphasic continuous waveform current with a frequency of 2 Hz, a pulse width of 50 microseconds and an intensity that produces visible motor responses of the innervated muscles was used, below the patient's pain threshold. The NT6021 Percutaneous Neuromodulation equipment of the Nutek® brand distributed by Fisiolab Ibérica® was used. This equipment has the CE marking, which denotes compliance with the requirements of the legislation of Royal Decree 414/1996 of March 1, which regulates medical devices. B.O.E. of April 24, 1996

Neurodynamics and manual therapy

Group Type: ACTIVE_COMPARATOR

Neurodynamic and manual therapy

Intervention Type: PROCEDURE

The manual therapy consisted of passive-assisted mobilization and massage therapy of the muscular and fascial tissue, beginning with the cervical area, kneading while asking the patient to rotate the neck and then in the same way along the muscles and soft tissues innervated by the target nerve.

Neurodynamic was performed in a passive-assisted manner, combining the patient's cervical mobilizations with the mobility of the upper limbs adapted to each case.

Interventions

Percutaneous Electrical Nerve Stimulation

In the PENS treatment, a biphasic continuous waveform current with a frequency of 2 Hz, a pulse width of 50 microseconds and an intensity that produces visible motor responses of the innervated muscles was used, below the patient's pain threshold. The NT6021 Percutaneous Neuromodulation equipment of the Nutek® brand distributed by Fisiolab Ibérica® was used. This equipment has the CE marking, which denotes compliance with the requirements of the legislation of Royal Decree 414/1996 of March 1, which regulates medical devices. B.O.E. of April 24, 1996

Intervention Type: PROCEDURE

Neurodynamic and manual therapy

The manual therapy consisted of passive-assisted mobilization and massage therapy of the muscular and fascial tissue, beginning with the cervical area, kneading while asking the patient to rotate the neck and then in the same way along the muscles and soft tissues innervated by the target nerve.

Neurodynamic was performed in a passive-assisted manner, combining the patient's cervical mobilizations with the mobility of the upper limbs adapted to each case.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• Subjects with upper limb neural symptomatology between 18 and 60 years of age, presenting two or more of the following conditions:
• Paresthesias in any territory of the shoulder girdle, arm or hand
• Pain at rest in any territory of the upper extremity.
• Pain at rest in any upper extremity territory
• Sensations of electric shock in any territory of the shoulder girdle, arm or hand.
• Allodynia or cutaneous hyperalgesia in any territory of the shoulder girdle, arm or hand.

Exclusion Criteria

• Less than 2 weeks of evolution
• Fracture in the affected upper extremity
• Suffering from another joint disorder such as osteoarthritis or rheumatic disease
• Suffering from generalized neuropathies due to neuromuscular disease or medication
• Inability to understand instructions or sign informed consent.
• Wearing a pacemaker or any electrical device implanted in the body
• Epilepsy
• Aversion or fear of needles
• Pregnant.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Rey Juan Carlos

OTHER

Sponsor Role: lead

Responsible Party

Josue Fernandez Carnero

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Physiotherapy and exercise center Origenkinesis

Alcorcón, Madrid, Spain

Site Status: RECRUITING

Countries

Spain

Central Contacts

Víctor Navarro López, PhD student

Role: CONTACT

victor.navarro@urjc.es

697371075

Facility Contacts

Víctor Navarro López, PhD student

Role: primary

victor.navarro@urjc.es

697371075

Other Identifiers

PENS210722

Identifier Type: -

Identifier Source: org_study_id