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

NCT05432973 | Unknown DMC

• 1 other identifier: PENS210722
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• Lanss Scale

  Useful to identify patients with a pain experience dominated by neuropathic mechanisms. It is based on the analysis of sensory description and exploration of sensory dysfunction at the patient's bedside. It consists of 7 items and is scored from 0 to 24. At a score of less than 12, the neuropathic component is considered unlikely. A score greater than or equal to 12 is considered probable neuropathic pain. It is a validated scale for patients with neuropathic pain.

  10 minutes

• Pain Detect Scale

  Screening questionnaire for neuropathic pain. This scale consists of a section dedicated to pain intensity and another that is responsible for assessing the qualitative aspect of pain, i.e., identifying whether the pain is of neuropathic characteristics. In the total of this scale the maximum possible score is 38 points and the minimum -1. For screening purposes, a score less than or equal to 12 is considered an unlikely neuropathic component. A score greater than or equal to 19 concludes that the neurological component in pain is probable.

  10 minutes

• Numerical Pain Rating Scale (NPRS)

  A unique 11-point numerical scale validated in patients with various painful conditions. Data obtained through NPRS are easily documented, intuitively interpretable, and meet regulatory requirements for pain assessment and documentation. This scale is reliable and validated for assessing patients with pain20. Score 0 corresponds to "no pain" and score 10 corresponds to "maximum possible pain". In this study, patients were asked to mark their maximum pain detected in the last week (NPRS Max) and their minimum pain detected in the last week (NPRS Min).

  1 minute

Secondary Outcomes (3)

• Neural stress test

  5 minutes

• DASH scale

  5 minutes

• Thermography

  10 minutes

Study Arms (2)

PENS

EXPERIMENTAL

Procedure: Percutaneous Electrical Nerve Stimulation

Neurodynamics and manual therapy

ACTIVE COMPARATOR

Procedure: Neurodynamic and manual therapy

Interventions

Percutaneous Electrical Nerve Stimulation 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

PENS

Neurodynamic and manual therapy 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.

Neurodynamics and manual therapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Physiotherapy and exercise center Origenkinesis

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Peripheral Nervous System Diseases; Neuralgia

Interventions

Transcutaneous Electric Nerve Stimulation; Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia; Complementary Therapies

Central Study Contacts

Víctor Navarro López, PhD student

CONTACT

697371075; victor.navarro@urjc.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 21, 2022
• First Posted: June 27, 2022
• Study Start: April 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: January 1, 2023
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

ES (1)