Percutaneous Neuromuscular Electrical Stimulation in Patients With Chronic Low Back Pain

NCT04243915 | Unknown

• 1 other identifier: EC 01/2019
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic low back pain is a common musculoskeletal condition affects the general population. Low back pain constitutes a major burden to health care system and society. Several authors have found that the deep abdominal muscles and multifidus are affected in low back pain. Dry needling has shown improve the cross-sectional area of the multifidus. Percutaneous electrical nerve stimulation has shown reduce pain in several conditions. There are not studies that had investigated the impact of percutaneous neuromuscular electrical stimulation (PNMES) in the deep muscles in patients with chronic low back pain. Hypothesis: PNMES in the multifidus muscle plus motor control exercise program in patients with chronic low back pain is better than sham PNMES plus exercise and transcutaneous electrical nerve stimulation (TENS) plus exercise

Conditions

Low Back Pain

Keywords

Percutaneous neuromuscular electrical stimulation; Percutaneous electrical nerve stimulation; Percutaneous electrical stimulation; Motor control exercise; Multifidus; Abdominal transverse; Non-specific chronic low back pain; Transcutaneous electric nerve stimulation; Exercise therapy

Outcome Measures

Primary Outcomes (2)

• Increased cross-sectional area in activation

  The increase in height from the resting position to the submaximal contraction in the lumbar multifidus will be measured

  Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

• Changes in the measurements of the multifidus and tranverse of the abdomen at rest.

  Changes in the height of the multifidus at rest

  Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

Secondary Outcomes (14)

• Intensity of Pain

  (Baseline, one hour from baseline after PNMES treatment 1 (only at rest), 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

• Pressure pain threshold using an algometer

  Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

• Temporal summation

  Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

• Conditioned pain modulation

  Baseline, one hour from baseline after PNMES treatment 1, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

• Pain Grade Questionnaire

  Baseline, 6 weeks from baseline, 18 weeks from baseline and 30 weeks from baseline

Study Arms (4)

PNMES plus exercise

EXPERIMENTAL

6-week intervention program with 3 treatment sessions of PNMES and motor control exercise program.

Other: Percutaneous neuromuscular electrical stimulation (PNMES) plus motor control exercise program

Sham PNMES (introducing the needle) plus exercise

SHAM COMPARATOR

Sham PNMES (introducing the needle) plus motor control exercise program

Other: Sham PNMES (introducing the needle) plus motor control exercise program

TENS plus exercise

ACTIVE COMPARATOR

6-week intervention program with 3 treatment sessions of TENS plus motor control exercise program.

Other: TENS plus motor control exercise program

Placebo PNMES (without inserting the needle) plus exercise

PLACEBO COMPARATOR

6-week intervention program with 3 treatment sessions of placebo PNMES (without inserting the needle) and exercise

Other: Sham PNMES (without inserting the needle) plus motor control exercise program

Interventions

Percutaneous neuromuscular electrical stimulation (PNMES) plus motor control exercise program OTHER

The technique consists of a muscular stimulation of the deep lumbar multifidus by means of a TENS current applied through four dry needling or acupuncture needles introduced by ultrasound guidance in said muscle 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.

Also known as: Percutaneous electric nerve stimulation (PENS)

PNMES plus exercise

Sham PNMES (introducing the needle) plus motor control exercise program OTHER

The same procedure will be performed as in the experimental treatment, but in this case, the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.

Also known as: Sham PENS

Sham PNMES (introducing the needle) plus exercise

TENS plus motor control exercise program OTHER

Transcutaneous electrical nerve stimulation will be applied through 4 patches / adhesives placed in your lower back for 30 minutes. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.

Also known as: TENS

TENS plus exercise

Sham PNMES (without inserting the needle) plus motor control exercise program OTHER

The same procedure will be performed as in the experimental treatment, but in this case, the needle will not be inserted and the electric current will be placebo and only the first 15 seconds will slightly notice it. This will add to a protocol of motor control exercises for deep abdominal and lumbar muscles.

Also known as: Sham PENS

Placebo PNMES (without inserting the needle) plus exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Low back pain more than 90 days of evolution

You may not qualify if:

• Spondylarthrosis
• History of fractures, luxations, surgery and/or musculoskeletal disorders in low back and lower limb.
• Leg pain or neuropathic pain (LANSS \<12).
• Neurological disorders, inflammatory and/or degenerative diseases.
• Having received as treatment techniques that involve needles on the previous 6 months to study enrollment or having received percutaneous electrical stimulation as a treatment before.
• Physiotherapy treatment in the last 4 weeks.
• Specific lumbar pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
• Contraindications of needle's insertions: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).
• Contraindications of electrical current.
• Drugs: morphine or opioids drugs.
• Depression
• Judicial dispute

Sponsors & Collaborators

• Universidad Rey Juan Carlos: lead

Study Sites (1)

Universidad Rey Juan Carlos

Alcorcón, Madrid, 28922, Spain

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; 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

Study Officials

• Josue Fernández-Carnero, PhD

  Universidad Rey Juan Carlos

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Arribas-Roamno, MsC

CONTACT

635937520; albertoarribasromano@gmail.com

Study Design

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

Model Details: Randomized, double-blind, placebo controlled clinical trial.

Study Record Dates

• First Submitted: January 15, 2020
• First Posted: January 28, 2020
• Study Start: April 10, 2021
• Primary Completion: June 10, 2024
• Study Completion: December 10, 2024
• Last Updated: May 15, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)