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Clinical Trials/NCT03794869
NCT03794869CompletedNot Applicable

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.

Universidad de Almeria1 site in 1 country68 target enrollmentStarted: April 15, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
68
Locations
1
Primary Endpoint
Algometry

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Single-Blind

Eligibility Criteria

Ages
25 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Arms & Interventions

Exercise program

Experimental

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

Intervention: Percutaneous electrostimulation treatment (EPS) (Other)

Percutaneous electrostimulation treatment (EPS)

Active Comparator

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.

Intervention: Exercise program (Other)

Outcomes

Primary Outcomes

Algometry

Time Frame: At baseline and immediate post-treatment

An instrument for measuring the degree of sensitivity to pain.

Secondary Outcomes

  • Goniometry(At baseline and immediate post-treatment)
  • Beck's Depression Inventory(At baseline and immediate post-treatment)
  • Mcquade Test(At baseline and immediate post-treatment)
  • Visual Analog Scale(At baseline and immediate post-treatment)
  • Oswestry Low Back Pain Disability Index.(At baseline and immediate post-treatment)
  • Roland-Morrys' Questionnaire(At baseline and immediate post-treatment)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Adelaida María Castro-Sánchez

PhD(Lecturer)

Universidad de Almeria

Study Sites (1)

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