Clinical trial NCT01124201: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
clinical trial
stabilization
muscle stretching exercises
exercise therapy
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2010-05-14
Enrollment: 45
Sex: ALL
Minimum age (years): 23
Maximum age (years): 53
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Pain (visual analogical scale and McGill pain questionnaire)
timeFrame: Six weeks
measure: Functional disability (Oswestry disability questionnaire)
timeFrame: Six weeks
measure: TrA muscle activation capacity (Pressure Biofeedback Unit = PBU)
timeFrame: Six weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: University of Sao Paulo General Hospital
Study officials:
affiliation: University of Sao Paulo
name: Fabio R França, MSc
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.