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

Low Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03420196
• Other study ID #: UAL-476
• Status: Completed
• Phase: N/A
• Start date: February 1, 2018
• Est. completion date: April 1, 2019

Study information

• Verified date: October 2019
• Source: Universidad de Almeria
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: April 1, 2019
• Est. primary completion date: January 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Physical Activity

Intervention

Other:
• Supervised 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
• Non 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

Locations

Country	Name	City	State
Spain	Universidad de Almería	Almería	Andalucía

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Almeria

Country where clinical trial is conducted

Spain, 

References & Publications (13)

Alonso J, Prieto L, Antó 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. — View Citation

Balagué F, Mannion AF, Pellisé 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. Review. — View Citation

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. — View Citation

Fairbank JC, Pynsent PB. The Oswestry Disability Index. Spine (Phila Pa 1976). 2000 Nov 15;25(22):2940-52; discussion 2952. Review. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View Citation

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. Review. Erratum in: Spine 2001 Apr 1;26(7):847. — View Citation

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. — View Citation

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. — View Citation

Ware JE Jr. SF-36 health survey update. Spine (Phila Pa 1976). 2000 Dec 15;25(24):3130-9. Review. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	At baseline, immediate post-treatment and at 6 months
Secondary	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	At baseline, immediate post-treatment and at 6 months
Secondary	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	At baseline, immediate post-treatment and at 6 months
Secondary	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.	At baseline, immediate post-treatment and at 6 months
Secondary	Change from Mcquade Test	It measures the isometric endurance of trunk flexion muscles	at baseline, immediate post-treatment and at 6 months
Secondary	Change from baseline in lumbar mobility flexion	It is determined by measuring the finger-to-floor distance.	at baseline, immediate post-treatment and at 6 months