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.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universidad de Almeria
- Enrollment
- 70
- Locations
- 2
- Primary Endpoint
- Change from baseline in Roland Morris Disability Questionnaire (RMDQ).
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 67 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Investigators
Adelaida María Castro-Sánchez
PhD
Universidad de Almeria