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CompletedNCT03420196Updated Oct 14, 2019

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

An interventional study of Supervised exercise program and Non supervised exercise program in Low Back Pain and Physical Activity, sponsored by Universidad de Almeria. Completed at 1 site in Spain. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2019-10-14.

Sponsored by Universidad de Almeria · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
64
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

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Conditions studied

  • Low Back Pain
  • Physical Activity

Keywords

  • low back pain
  • physical therapy
  • randomized clinical trial
  • exercise program
03

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
64 participants (actual)

Study arms

  • Experimental
    Supervised Rehabilitation program

    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

  • Active comparator
    Nonsupervised rehabilitation program

    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

  • OtherSupervised exercise program

    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

  • OtherNon supervised exercise program

    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

05

What researchers measure

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

    Time frame: at baseline,immediate post-treatment and at 6 months

Secondary outcomes

  1. 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

    Time frame: At baseline, immediate post-treatment and at 6 months

  2. 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

    Time frame: At baseline, immediate post-treatment and at 6 months

  3. 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

    Time frame: At baseline, immediate post-treatment and at 6 months

  4. 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.

    Time frame: At baseline, immediate post-treatment and at 6 months

  5. Change from Mcquade Test

    It measures the isometric endurance of trunk flexion muscles

    Time frame: at baseline, immediate post-treatment and at 6 months

  6. Change from baseline in lumbar mobility flexion

    It is determined by measuring the finger-to-floor distance.

    Time frame: at baseline, immediate post-treatment and at 6 months

06

Study locations

1 site
  • Universidad de Almería
    Almería, Andalucía 04120, Spain
07

References and documents

Publications

  • 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. PubMed 22466247 ↗
  • 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. PubMed 25395111 ↗
  • 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. PubMed 21982256 ↗
  • 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. doi: 10.1016/S0140-6736(16)32606-X. PubMed 27733282 ↗
  • 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. PubMed 28885356 ↗
  • 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. PubMed 28420353 ↗
  • 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. PubMed 28686644 ↗
  • 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. PubMed 6222486 ↗
  • 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. PubMed 6222487 ↗
  • 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. Erratum In: Spine 2001 Apr 1;26(7):847. PubMed 11124727 ↗
  • 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. PubMed 11074683 ↗
  • 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. PubMed 11124729 ↗
  • 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. PubMed 7783470 ↗
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Registry details

Key details

Study ID
NCT03420196
Lead sponsor
Universidad de Almeria
Responsible party
Adelaida María Castro-Sánchez (PhD (Lecturer), Universidad de Almeria) — Principal investigator
First posted
Feb 5, 2018
Start date
Feb 1, 2018
Primary completion
Jan 31, 2019
Completion
Apr 1, 2019
Last update
Oct 14, 2019

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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