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NCT Number: NCT03794869

Short-term Effects of Exercise Program Versus Electropuncture in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.

This study evaluate the effectiveness that exists when performing a treatment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture in patients with chronic low back pain.

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Key information

Conditions

Low Back Pain Back Pain Electroacupuncture Exercise Program Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

25 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Almeria University

Almería, 04001, Spain

About this study

Low back pain has a high prevalence in all European countries, appearing as the main cause of activity limitation in people under 45 years of age. It has got a high recurrence, which decreases the activities of daily life, facilitates the focus of attention to pain and increases the fear of movement, with the consequent muscular atrophy. A serie cases will be conducted comparing a a table of exercises versus electropuncture.

Objective: Evaluate the effectiveness that exists when performing a tratment based on a table of exercises for strengthening the lumbar muscles versus a treatment based on electropuncture.

Methods: A sample of 12 subjects with chronic low back pain will be assigned to an exercise program or dry electropuncture treatment (EPS), during 4 weeks (2 sessions/week). The measurement variables selected for the study were the followings: Straight Leg Raise, Vasalva, Gaesslen test, algometry (pressure pain threshold), goniometry (measurement of the range of motion), Scale of disability for low back pain of Oswestry, Beck's Depression Inventory (BDI), Visual Analogue Scale (EVA), Mcquade's Test and the Roland-Morrys' Questionnaire, developing a pre-treatment and post-treatment assessment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Chronic non-specific low back pain persisting ≥ 3 months.
  • Age between 25 and 60 years.
  • Not currently receiving physical therapy.

Exclusion criteria

  • Presence of lumbar stenosis.
  • Presence of clinical signs of radiculopathy.
  • Diagnosis of spondylolisthesis.
  • Diagnosis of fibromyalgia.
  • Treatment with corticosteroid or pharmachological medication within the paset 2 weeks.
  • A history of spinal surgery.
  • Central or peripheral nervous system disease

Treatment and study plan

Percutaneous electrostimulation treatment (EPS)

Other

Apply dry needles in a tight band of some of the muscles that most affect the appearance of low back pain, such as: paravertebral, lumbar quadrate, gluteus medius and pyramidal, and administer analgesic microcurrents.

exercise program

Other

It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.

Primary outcomes

  1. Algometry

    Time frame: At baseline and immediate post-treatment

    An instrument for measuring the degree of sensitivity to pain.

Secondary outcomes

  1. Goniometry

    Time frame: At baseline and immediate post-treatment

    Measurement of the range of motion

  2. Beck's Depression Inventory

    Time frame: At baseline and immediate post-treatment

    The state of depression will be determined with the Beck Depression Inventory (BDI), a self-applied 21-item questionnaire that assesses a wide spectrum of depressive symptoms. It focuses on the cognitive components of depression, which represent around 50% of the total questionnaire score.

  3. Visual Analog Scale

    Time frame: At baseline and immediate post-treatment

    Pain will be assessed with the Visual Analog Scale (VAS), which assesses the pain intensity and degree of relief experienced by the patient (scored of 0 = no pain; 10 = unbearable pain).

  4. Oswestry Low Back Pain Disability Index.

    Time frame: At baseline and immediate post-treatment

    It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points

  5. Roland-Morrys' Questionnaire

    Time frame: At baseline and immediate post-treatment

    This is a self-reported questionnaire consisting in 24 items reflecting limitations in different activities of daily living attributed to low back pain including walking, vending over, sitting, lying down, dressing, sleeping, self-care and daily activities

  6. Mcquade Test

    Time frame: At baseline and immediate post-treatment

    It measures the isometric endurance of trunk flexion muscles

Sponsors and collaborators

Lead sponsor

Universidad de Almeria

Other

Registry information

Official study title

Short-term Effects of Exercise Program Versus Electropuncture on Pain, Depression, Range of Motion and Disability, in Patients With Chronic Non-specific Low Back Pain: A Randomized Clinical Trial.

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jan 7, 2019
Registry last updated
Jan 9, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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