Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain
Primary Purpose
Chronic Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Stabilization , strengthening and stretching
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, clinical trial, stabilization, muscle stretching exercises, exercise therapy
Eligibility Criteria
Inclusion Criteria:
- low back pain for more than 3 months
- patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.
Exclusion Criteria:
- past history of back surgery
- rheumatologic disorders
- spine infections
- spine exercise training in the 3 months before study onset.
Sites / Locations
- University of Sao Paulo General Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Stabilization group
Strengthening group
Stretching group
Arm Description
In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles.
In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles.
Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles
Outcomes
Primary Outcome Measures
Pain (visual analogical scale and McGill pain questionnaire)
Functional disability (Oswestry disability questionnaire)
TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
Secondary Outcome Measures
Full Information
NCT ID
NCT01124201
First Posted
May 13, 2010
Last Updated
May 13, 2010
Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
1. Study Identification
Unique Protocol Identification Number
NCT01124201
Brief Title
Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain
Official Title
Lumbar Segmental Stabilization, Strengthening and Stretching in Chronic Low Back Pain: a Comparative Study
Study Type
Interventional
2. Study Status
Record Verification Date
March 2007
Overall Recruitment Status
Completed
Study Start Date
February 2007 (undefined)
Primary Completion Date
March 2008 (Actual)
Study Completion Date
June 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
University of Sao Paulo General Hospital
Collaborators
Fundação de Amparo à Pesquisa do Estado de São Paulo
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study was to compare the efficacy of three exercise programs in patients with chronic low back pain: Segmental stabilization, superficial strengthening and stretching. Groups were contrasted regarding pain, functional disability and TrA muscle activation capacity. The three groups of exercise improved pain and functional disabilities, and the Segmental stabilization group was better in the ability to recruit TrA muscle.
Detailed Description
Objective: To contrast the efficacy of three exercise programs, segmental stabilization and strengthening of abdominal and trunk muscle and lumbar stretching on pain, functional impairment, and activation of the transversus abdominis muscle (TrA), in individuals with chronic low back pain.
Design: Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus) (n=15, mean age 42,02 ± 8,15), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) (n=15, mean age 41,71±6,41) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles) (n=15 mean age 41,53 ± 4,41). Groups were contrasted regarding pain (visual analogical scale and McGill pain questionnaire), functional disability (Oswestry disability questionnaire) and TrA muscle activation capacity (Pressure Biofeedback Unit = PBU). The program lasted 6 weeks, and sessions happened twice a week, with duration of 30 minutes each. Analysis of variance was used for inter and intragroup comparisons. Significance level was established at 5%.
Patients attended two weekly sessions during six weeks and were evaluated for pain (visual analogue scale and McGill Pain Questionnaire), functional disability (Oswestry disability index), and ability to contract the TrA (Pressure biofeedback unit) before and after the treatment. The treatment program consisted of 30 minutes sessions. The Anova one-way and Tukey´s Post Hoc were used to compare groups. The significance level adopted was 5%.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, clinical trial, stabilization, muscle stretching exercises, exercise therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stabilization group
Arm Type
Experimental
Arm Description
In the Segmental Stabilization group exercises focused on the transversus abdominis and lumbar multifidus muscles.
Arm Title
Strengthening group
Arm Type
Experimental
Arm Description
In the Superficial Strengthening group, exercises focused on the rectus abdominis, abdominus obliquus internus, abdominus obliquus externus and erector spinae muscles.
Arm Title
Stretching group
Arm Type
Experimental
Arm Description
Stretching group: erector spinae, posterior connective tissues and ischiotibials muscles
Intervention Type
Other
Intervention Name(s)
Stabilization , strengthening and stretching
Other Intervention Name(s)
Pressure Biofeedback Unit
Intervention Description
Interventions were conducted over 6 weeks, twice per week, lasting 30 minutes each. Sessions were supervised by the investigator, and participants were instructed to report any adverse event. Groups were instructed not to participate in any other physical program during the study. Forty-five patients were randomized into three groups namely: Segmental stabilization group (ES)(transversus abdominis and lumbar multifidus), superficial strengthening group (FS)(rectus abdominis, oblique abdominal muscles and erector spinae muscles) and stretching group (AL) (erector spinae, posterior connective tissues and ischiotibials muscles). Patients were evaluated for pain , functional disability,and ability to contract the TrA before and after the treatment.
Primary Outcome Measure Information:
Title
Pain (visual analogical scale and McGill pain questionnaire)
Time Frame
Six weeks
Title
Functional disability (Oswestry disability questionnaire)
Time Frame
Six weeks
Title
TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
Time Frame
Six weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
low back pain for more than 3 months
patients willing to participate and could participate in an exercise program safely and without cognitive impairments that would limit their participation.
Exclusion Criteria:
past history of back surgery
rheumatologic disorders
spine infections
spine exercise training in the 3 months before study onset.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fabio R França, MSc
Organizational Affiliation
University of Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Sao Paulo General Hospital
City
Sao Paulo
Country
Brazil
12. IPD Sharing Statement
Citations:
PubMed Identifier
17304690
Citation
Barr KP, Griggs M, Cadby T. Lumbar stabilization: a review of core concepts and current literature, part 2. Am J Phys Med Rehabil. 2007 Jan;86(1):72-80. doi: 10.1097/01.phm.0000250566.44629.a0.
Results Reference
background
PubMed Identifier
16716640
Citation
MacDonald DA, Moseley GL, Hodges PW. The lumbar multifidus: does the evidence support clinical beliefs? Man Ther. 2006 Nov;11(4):254-63. doi: 10.1016/j.math.2006.02.004. Epub 2006 May 23.
Results Reference
background
PubMed Identifier
19474006
Citation
Ferreira PH, Ferreira ML, Maher CG, Refshauge K, Herbert RD, Hodges PW. Changes in recruitment of transversus abdominis correlate with disability in people with chronic low back pain. Br J Sports Med. 2010 Dec;44(16):1166-72. doi: 10.1136/bjsm.2009.061515. Epub 2009 May 26.
Results Reference
background
PubMed Identifier
14715404
Citation
Liddle SD, Baxter GD, Gracey JH. Exercise and chronic low back pain: what works? Pain. 2004 Jan;107(1-2):176-90. doi: 10.1016/j.pain.2003.10.017. Erratum In: Pain. 2004 May;109(1-2):200-1.
Results Reference
background
PubMed Identifier
15867409
Citation
Hayden JA, van Tulder MW, Malmivaara AV, Koes BW. Meta-analysis: exercise therapy for nonspecific low back pain. Ann Intern Med. 2005 May 3;142(9):765-75. doi: 10.7326/0003-4819-142-9-200505030-00013.
Results Reference
background
PubMed Identifier
21120303
Citation
Franca FR, Burke TN, Hanada ES, Marques AP. Segmental stabilization and muscular strengthening in chronic low back pain: a comparative study. Clinics (Sao Paulo). 2010;65(10):1013-7. doi: 10.1590/s1807-59322010001000015.
Results Reference
derived
Links:
URL
http://www.teses.usp.br/teses/disponiveis/5/5163/tde-05032010-140030/
Description
Link to my thesis in portuguese.
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Lumbar Stabilization, Strengthening and Stretching in Chronic Low Back Pain
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