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Clinical Trials/NCT03469024
NCT03469024
Completed
N/A

Comparison of Effectiveness of a Home Rehabilitation Program vs an e-Healt Program on Disability, Pain, Fear of Movement, Quality of Life and Spinal Mobility in Patients With Chronic Low Back Pain.

Universidad de Almeria1 site in 1 country70 target enrollmentMay 1, 2018
ConditionsLow Back Pain

Overview

Phase
N/A
Intervention
Not specified
Conditions
Low Back Pain
Sponsor
Universidad de Almeria
Enrollment
70
Locations
1
Primary Endpoint
Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

The main objetive of this study is to analyze the effectiveness of a home rehabilitaton program vs a e-Health program. Therapeutic approach will be by electroanalgesia and exercise of patients with chronic low back pain.

Detailed Description

A double blind clinical trial will be developed in a sample of 80 subjects with chronic low back pain. Patients will receive 3 weekly sessions of electroanalgesia and an exercise program for 8 weeks, for a total of 24 sessions. The aim is to analyze the effectiveness of a home rehabilitation program vs a web platform program on disability, pain, fear of movement, quality of life, resistance of the trunk flexors, lumbar mobility in flexion and muscular electrical activity.

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
April 15, 2021
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Adelaida María Castro-Sánchez

PhD

Universidad de Almeria

Eligibility Criteria

Inclusion Criteria

  • Low back pain ≥ 3 months.
  • Age between 30 and 67 years old.
  • Score ≥ 4 points on the Roland Morris Disability Questionnaire.
  • Not being receiving physical therapy.

Exclusion Criteria

  • Presence of lumbar stenosis.
  • Diagnosis of spondylolisthesis.
  • Diagnosis of fibromyalgia.
  • Treatment with corticosteroids or oral medication in recent weeks.
  • History of spine surgery.
  • Contraindication of analgesic electrical therapy.
  • Have previously received a treatment of electrical analgesia or exercise.
  • Central or peripheral nervous system disease.
  • Agoraphobia

Outcomes

Primary Outcomes

Change from baseline in Roland Morris Disability Questionnaire (RMDQ).

Time Frame: At baseline, at 8 weeks and at 6 months

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.

Secondary Outcomes

  • Change from baseline in pain intensity. Visual analogue scale.(At baseline, at 8 weeks and at 6 months)
  • Change from baseline in lumbar mobility flexion.(At baseline, at 8 weeks and at 6 months)
  • Change from baseline in disability. Oswestry Low Back Pain Disability Idex.(At baseline, at 8 weeks and at 6 months.)
  • Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.(At baseline, at 8 weeks and at 6 months)
  • Change from Mcquade Test.(At baseline, at 8 weeks and at 6 months)
  • Change from baseline on Quality of Life. SF-36 Health questionnaire.(At baseline, at 8 weeks and at 6 months)
  • Changes from baseline in Lumbar electromyography.(At baseline, at 8 weeks and at 6 months)
  • Change from baselina in range of motion and lumbar segmental mobility(At baseline, at 8 weeks and at 6 months)

Study Sites (1)

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