Efficacy of a Supervised Physical Therapy Rehabilitation Program vs Nonsupervised in Non-specific Low Back Pain
NCT ID: NCT03420196
Last Updated: 2019-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
64 participants
INTERVENTIONAL
2018-02-01
2019-04-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Effectiveness of a Home Rehabilitation Program vs an e-Health Program in Patients With Chronic Low Back Pain
NCT03469024
A Study Protocol Comparing a Home Rehabilitation Program Versus e-Health Program in Low Back Pain
NCT04283370
Effects of Hipopressive Exercises in Nonspecific Low Back Pain
NCT03565926
Feasibility of a One-day-and-a-half for Patients With Low Back Pain
NCT04133818
Effects of a Prehabilitation Program in Patients Undergoing Lumbar Radiculopathy Surgery
NCT06145620
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
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
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.
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
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Age between 18 and 65 years.
* A score ≥ 4 in Roland Morris Disability Questionnaire.
* Not currently receiving physical therapy.
Exclusion Criteria
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Universidad de Almeria
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Adelaida María Castro-Sánchez
PhD (Lecturer)
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Universidad de Almería
Almería, Andalusia, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
UAL-476
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.