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Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain

Primary Purpose

Low Back Pain, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Supervised exercise program
Non supervised exercise program
Sponsored by
Universidad de Almeria
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, physical therapy, randomized clinical trial, exercise program

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Chronic non-specific low back pain persisting ≥ 3 months.
  • Age between 18 and 65 years.
  • A score ≥ 4 in Roland Morris Disability Questionnaire.
  • 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.

Sites / Locations

  • Universidad de Almería

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Supervised Rehabilitation program

Nonsupervised rehabilitation program

Arm Description

It will be consist in a supervised exercise program by physical therapist, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility

It will consist in an exercise program for home, nonsupervised, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility. The patients will perform an exercise program at home.

Outcomes

Primary Outcome Measures

Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
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 Outcome Measures

Change from baseline in disability. Oswestry Low Back Pain Disability Index.
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Change from baseline in pain intensity (Visual Analogue Scale).
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
It is a 17-item questionnaire that measures the fear of movement and (re)injury
Change from baseline on Quality of Life.
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Change from Mcquade Test
It measures the isometric endurance of trunk flexion muscles
Change from baseline in lumbar mobility flexion
It is determined by measuring the finger-to-floor distance.

Full Information

First Posted
January 28, 2018
Last Updated
October 11, 2019
Sponsor
Universidad de Almeria
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1. Study Identification

Unique Protocol Identification Number
NCT03420196
Brief Title
Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain
Official Title
Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised on Pain, Disability, Quality of Life and Kinesiophobia in Patients With Non-specific Low Back Pain
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
February 1, 2018 (Actual)
Primary Completion Date
January 31, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Almeria

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This study compares the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program on pain, disability, quality of life and kinesiophobia in patients with non-specific low back pain.
Detailed Description
Low back pain is one of the most common problems of population, being a priority for health systems. It has got a high prevalence and recurrence, affecting in a social and economic way, and, it is one of principal causes of laboral absenteism. A randomized clinical trial will be conducted comparing a supervised physical therapy rehabilitation program vs a non supervised rehabilitation program. Objective: to compare the efficacy of a supervised rehabilitation program vs a non supervised rehabilitation program in patients with non-specific low back pain. Methods: Sixt-four subjects with chronic non-specific low back pain will be assigned to supervised rehabilitation program or non supervised rehabilitation program during 4 weeks (5 sessions/week). Outcomes measures will be the following: disability, pain intensity, fear of movement, quality of life, McQuade Test, and lumbar mobility flexion.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain, Physical Activity
Keywords
low back pain, physical therapy, randomized clinical trial, exercise program

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single-Blind
Allocation
Randomized
Enrollment
64 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Supervised Rehabilitation program
Arm Type
Experimental
Arm Description
It will be consist in a supervised exercise program by physical therapist, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility
Arm Title
Nonsupervised rehabilitation program
Arm Type
Active Comparator
Arm Description
It will consist in an exercise program for home, nonsupervised, including the following structures: diaphragm, tranverse abdominis muscle, pelvic, gluteus, CORE and spinal mobility. The patients will perform an exercise program at home.
Intervention Type
Other
Intervention Name(s)
Supervised exercise program
Intervention Description
It will consist in a supervised exercise program, including the following exercises: Diaphragmatic breathing. Transverse abdomLateral leg raise for gluteus mediuminis muscle activation. Pelvic swing. Gluteus bridge. Spinal mobility. Spinal extensor muscles strengthening Frontal plank Side plank. Lateral leg raise for gluteus medium
Intervention Type
Other
Intervention Name(s)
Non supervised exercise program
Intervention Description
It will consist in a non supervised exercise program, including the following exercises: Diaphragmatic breathing. Transverse abdomLateral leg raise for gluteus mediuminis muscle activation. Pelvic swing. Gluteus bridge. Spinal mobility. Spinal extensor muscles strengthening Frontal plank Side plank. Lateral leg raise for gluteus medium
Primary Outcome Measure Information:
Title
Change from baseline in Roland Morris Disability Questionnaire (RMDQ)
Description
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
Time Frame
at baseline,immediate post-treatment and at 6 months
Secondary Outcome Measure Information:
Title
Change from baseline in disability. Oswestry Low Back Pain Disability Index.
Description
It has 10 items associated to activities of daily living, each item has a puntuation fron 0 to 5 points
Time Frame
At baseline, immediate post-treatment and at 6 months
Title
Change from baseline in pain intensity (Visual Analogue Scale).
Description
A 10-point Numerical Pain Scale (0: no pain, 10: maximum pain) assesses the intensity of pain
Time Frame
At baseline, immediate post-treatment and at 6 months
Title
Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.
Description
It is a 17-item questionnaire that measures the fear of movement and (re)injury
Time Frame
At baseline, immediate post-treatment and at 6 months
Title
Change from baseline on Quality of Life.
Description
SF-36 Health questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
Time Frame
At baseline, immediate post-treatment and at 6 months
Title
Change from Mcquade Test
Description
It measures the isometric endurance of trunk flexion muscles
Time Frame
at baseline, immediate post-treatment and at 6 months
Title
Change from baseline in lumbar mobility flexion
Description
It is determined by measuring the finger-to-floor distance.
Time Frame
at baseline, immediate post-treatment and at 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Chronic non-specific low back pain persisting ≥ 3 months. Age between 18 and 65 years. A score ≥ 4 in Roland Morris Disability Questionnaire. 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.
Facility Information:
Facility Name
Universidad de Almería
City
Almería
State/Province
Andalucía
ZIP/Postal Code
04120
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
22466247
Citation
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Results Reference
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PubMed Identifier
25395111
Citation
Manchikanti L, Singh V, Falco FJ, Benyamin RM, Hirsch JA. Epidemiology of low back pain in adults. Neuromodulation. 2014 Oct;17 Suppl 2:3-10. doi: 10.1111/ner.12018.
Results Reference
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PubMed Identifier
21982256
Citation
Balague F, Mannion AF, Pellise F, Cedraschi C. Non-specific low back pain. Lancet. 2012 Feb 4;379(9814):482-91. doi: 10.1016/S0140-6736(11)60610-7. Epub 2011 Oct 6.
Results Reference
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PubMed Identifier
27733282
Citation
GBD 2015 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 310 diseases and injuries, 1990-2015: a systematic analysis for the Global Burden of Disease Study 2015. Lancet. 2016 Oct 8;388(10053):1545-1602. doi: 10.1016/S0140-6736(16)31678-6. Erratum In: Lancet. 2017 Jan 7;389(10064):e1.
Results Reference
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PubMed Identifier
28885356
Citation
Hu H, Zheng Y, Wang X, Chen B, Dong Y, Zhang J, Liu X, Gong D. Correlations between lumbar neuromuscular function and pain, lumbar disability in patients with nonspecific low back pain: A cross-sectional study. Medicine (Baltimore). 2017 Sep;96(36):e7991. doi: 10.1097/MD.0000000000007991.
Results Reference
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PubMed Identifier
28420353
Citation
Jubany J, Danneels L, Angulo-Barroso R. The influence of fatigue and chronic low back pain on muscle recruitment patterns following an unexpected external perturbation. BMC Musculoskelet Disord. 2017 Apr 19;18(1):161. doi: 10.1186/s12891-017-1523-3.
Results Reference
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PubMed Identifier
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Citation
Marshall PWM, Schabrun S, Knox MF. Physical activity and the mediating effect of fear, depression, anxiety, and catastrophizing on pain related disability in people with chronic low back pain. PLoS One. 2017 Jul 7;12(7):e0180788. doi: 10.1371/journal.pone.0180788. eCollection 2017.
Results Reference
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Citation
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Citation
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Citation
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Citation
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Results Reference
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Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain

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