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

NCT03420196 | Completed

• 1 other identifier: UAL-476
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Physical Activity

Keywords

low back pain; physical therapy; randomized clinical trial; exercise program

Outcome Measures

Primary Outcomes (1)

• 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

  at baseline,immediate post-treatment and at 6 months

Secondary Outcomes (6)

• Change from baseline in disability. Oswestry Low Back Pain Disability Index.

  At baseline, immediate post-treatment and at 6 months

• Change from baseline in pain intensity (Visual Analogue Scale).

  At baseline, immediate post-treatment and at 6 months

• Change from baseline in Fear of Movement. Tampa Scale of kinesiophobia.

  At baseline, immediate post-treatment and at 6 months

• Change from baseline on Quality of Life.

  At baseline, immediate post-treatment and at 6 months

• Change from Mcquade Test

  at baseline, immediate post-treatment and at 6 months

Study Arms (2)

Supervised Rehabilitation program

EXPERIMENTAL

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

Other: Supervised exercise program

Nonsupervised rehabilitation program

ACTIVE COMPARATOR

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.

Other: Non supervised exercise program

Interventions

Supervised exercise program OTHER

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

Supervised Rehabilitation program

Non supervised exercise program OTHER

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

Nonsupervised rehabilitation program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Almeria: lead

Study Sites (1)

Universidad de Almería

Almería, Andalusia, 04120, Spain

Location

Related Publications (13)

• Delitto A, George SZ, Van Dillen L, Whitman JM, Sowa G, Shekelle P, Denninger TR, Godges JJ; Orthopaedic Section of the American Physical Therapy Association. Low back pain. J Orthop Sports Phys Ther. 2012 Apr;42(4):A1-57. doi: 10.2519/jospt.2012.42.4.A1. Epub 2012 Mar 30.

  PMID: 22466247 BACKGROUND

• 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.

  PMID: 25395111 BACKGROUND

• 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.

  PMID: 21982256 BACKGROUND

• 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.

  PMID: 27733282 BACKGROUND

• 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.

  PMID: 28885356 BACKGROUND

• 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.

  PMID: 28420353 BACKGROUND

• 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.

  PMID: 28686644 BACKGROUND

• Roland M, Morris R. A study of the natural history of back pain. Part I: development of a reliable and sensitive measure of disability in low-back pain. Spine (Phila Pa 1976). 1983 Mar;8(2):141-4. doi: 10.1097/00007632-198303000-00004. No abstract available.

  PMID: 6222486 BACKGROUND

• Roland M, Morris R. A study of the natural history of low-back pain. Part II: development of guidelines for trials of treatment in primary care. Spine (Phila Pa 1976). 1983 Mar;8(2):145-50. doi: 10.1097/00007632-198303000-00005.

  PMID: 6222487 BACKGROUND

• Roland M, Fairbank J. The Roland-Morris Disability Questionnaire and the Oswestry Disability Questionnaire. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3115-24. doi: 10.1097/00007632-200012150-00006. No abstract available.

  PMID: 11124727 BACKGROUND

• Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. doi: 10.1097/00007632-200011150-00017.

  PMID: 11074683 BACKGROUND

• Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. doi: 10.1097/00007632-200012150-00008. No abstract available.

  PMID: 11124729 BACKGROUND

• Alonso J, Prieto L, Anto JM. [The Spanish version of the SF-36 Health Survey (the SF-36 health questionnaire): an instrument for measuring clinical results]. Med Clin (Barc). 1995 May 27;104(20):771-6. Spanish.

  PMID: 7783470 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-Blind
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD (Lecturer)

Study Record Dates

• First Submitted: January 28, 2018
• First Posted: February 5, 2018
• Study Start: February 1, 2018
• Primary Completion: January 31, 2019
• Study Completion: April 1, 2019
• Last Updated: October 14, 2019

Record last verified: 2019-10

Locations

ES (1)