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

Sponsor

Universidad de Almeria (Other)

Overall Status

Completed

CT.gov ID

NCT03794869

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

66.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Low Back Pain Exercise Program Electroacupuncture	Other: Percutaneous electrostimulation treatment (EPS) Other: Exercise program	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

68 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Masking Description:

Single-Blind

Primary Purpose:

Treatment

Official 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.

Actual Study Start Date :

Apr 15, 2018

Actual Primary Completion Date :

Apr 16, 2018

Actual Study Completion Date :

May 16, 2018

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise program It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of the core: awareness of breathing, front and side plate abdominal, glute bridge/hip elevations, lift extended leg, pelvic tilt, hamstring stretch, strengthening lower abdominals, cat-camel posture, trunk rotations with flexed knees, rolling in sitting and lumbar extension with hip extensión in prone	Other: Percutaneous electrostimulation treatment (EPS) 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.
Active Comparator: Percutaneous electrostimulation treatment (EPS) 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.	Other: Exercise program It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of CORE.

Arm

Intervention/Treatment

Experimental: Exercise program

It will be consist in a program of lumbo-pelvic stabilization exercises and strengthening of the core: awareness of breathing, front and side plate abdominal, glute bridge/hip elevations, lift extended leg, pelvic tilt, hamstring stretch, strengthening lower abdominals, cat-camel posture, trunk rotations with flexed knees, rolling in sitting and lumbar extension with hip extensión in prone

Other: Percutaneous electrostimulation treatment (EPS)

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.

Active Comparator: Percutaneous electrostimulation treatment (EPS)

Other: Exercise program

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

Outcome Measures

Primary Outcome Measures

Algometry [At baseline and immediate post-treatment]
An instrument for measuring the degree of sensitivity to pain.

Secondary Outcome Measures

Goniometry [At baseline and immediate post-treatment]
Measurement of the range of motion
Beck's Depression Inventory [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.
Visual Analog Scale [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).
Oswestry Low Back Pain Disability Index. [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
Roland-Morrys' Questionnaire [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
Mcquade Test [At baseline and immediate post-treatment]
It measures the isometric endurance of trunk flexion muscles

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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