Therapeutic Exercise and Therapeutic Patient Education With or Without Manual Therapy for Chronic Nonspecific Low Back Pain.

NCT03181659 | Unknown DMC

• 1 other identifier: 1
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical trial study evaluates the effectiveness of a multimodal physiotherapy treatment based on a biobehavioural paradigm in the treatment of non-specific chronic low back pain. The experimental group received treatment based on therapeutic exercise, education in neuroscience, and manual therapy, contrary to the control group, which did not receive manual therapy treatment.

Conditions

Chronic Nonspecific Low Back Pain; Low Back Pain

Keywords

Musculoskeletal Manipulations; Exercise; Patient Education; Low back pain

Outcome Measures

Primary Outcomes (3)

• Disability and function

  The Roland Morris Disability Questionnaire (RMDQ) will be used to assess the physical disability in activities of daily living due to low back pain. This self-administered questionnaire consists of 24 items that refer to the limitations of daily activities as a result of low back pain (Roland and Morris, 1983). The total score ranges from 0 to 24 (higher scores indicate a more severe disability level). The Spanish version of RMDQ has been demonstrated as having acceptable psychometric properties (Kovacs et al., 2002).

  Change from disability and function at 3 months.

• Pain Intensity

  Pain Intensity will be measured with Visual Analogue Scale (VAS). The VAS consists of a 100-mm line, the left side of which represents "no pain" whereas the right side represents "maximal pain" (Bijur et al., 2001).

  Change from pain intensity at 3 months.

• Isometric Force Endurance

  To evaluate the force endurance of the lumbar stabilizing muscles, the Ito test is used to test isometric isometric elevation of the trunk (Moreau et al., 2001). This assay was described by Ito et al. 1996 and has a good level of reliability (Ito et al., 1996). In this test the subject will be asked to lie prone on the stretcher. Then, the subject must elevate his head and trunk of the stretcher, in the way that his sternum does not come into contact with it, maintaining the maximum possible cervical flexion. The subjects must maintain this position in the longest possible time, finishing the test after 5 minutes, a state of fatigue or pain appears.

  Change from Isometric force endurance at 3 months.

Secondary Outcomes (11)

• Temporal Summation

  Temporal Summation will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.

• Two-point discrimination

  Two-Point discrimination will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.

• Funcional range

  Funcional range will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.

• Strength of lumbar region

  Strength of the lumbar region will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.

• Motor control of lumbar region

  Motor control will be assessed up to 1 week before treatment, up to 1 week after treatment and after 3 months of follow up.

Study Arms (4)

Group 1: patients with NSCLBP who do not seek care

EXPERIMENTAL

Manual Therapy, Therapeutic Education, Therapeutic Exercice

Procedure: Manual Therapy, Therapeutic Education, Therapeutic Exercice

Group 2: patients with NSCLBP who do not seek care

EXPERIMENTAL

Therapeutic Education, Therapeutic Exercice

Procedure: Therapeutic Education, Therapeutic Exercice

Group 3: patients with NSCLBP who seek care

EXPERIMENTAL

Manual Therapy, Therapeutic Education, Therapeutic Exercice

Procedure: Manual Therapy, Therapeutic Education, Therapeutic Exercice

Group 4: patients with NSCLBP who seek care

EXPERIMENTAL

Therapeutic Education, Therapeutic Exercice

Procedure: Therapeutic Education, Therapeutic Exercice

Interventions

Manual Therapy, Therapeutic Education, Therapeutic Exercice PROCEDURE

They will receive 8 sessions (2 sessions per week) of joint and neural manual therapy, and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation. The therapeutic exercise program is based on stabilization of the lumbopelvic region.

Group 1: patients with NSCLBP who do not seek care; Group 3: patients with NSCLBP who seek care

Therapeutic Education, Therapeutic Exercice PROCEDURE

They will receive a total of 8 sessions (2 sessions per week) of therapeutic exercise based on the stabilization of the lumbopelvic region and will receive 4 sessions (1 session per week) of neuroscience education in which mirror therapy and image observation.

Group 2: patients with NSCLBP who do not seek care; Group 4: patients with NSCLBP who seek care

Eligibility Criteria

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

You may qualify if:

• Patients with non specific low back pain lasting for at least 3 months.
• Patients with pain intensity corresponding to at least 3 points on a 10 point analogue visual scale.
• Patients with pain frequency corresponding to at least 10 days per month.
• Men and Women between 18 and 65 years old.

You may not qualify if:

• Presence of trauma or surgery to the thoracic or lumbar region.
• Patients with diagnosis of discopathy or radicular symptoms.
• Patients with history of previous physical-therapy intervention for the lumbar region in the last month.
• Any cognitive impairment that hindered viewing of audiovisual material.
• difficulty understanding or communicating.
• Presence of systemic pathology, Central Nervous System or rheumatic disease.
• Inadequate understanding of the Spanish language to follow instructions for measuring and treatment.
• Collaboration of pregnant women.

Sponsors & Collaborators

• Roy La Touche Arbizu: lead
• Centro Universitario La Salle: collaborator
• Servicio Madrileño de Salud, Madrid, Spain: collaborator
• Universidad Autonoma de Madrid: collaborator

Study Sites (1)

CSEU La Salle

Madrid, 28023, Spain

RECRUITING

Related Publications (17)

• 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

• Kovacs FM, Llobera J, Gil Del Real MT, Abraira V, Gestoso M, Fernandez C, Primaria Group KA. Validation of the spanish version of the Roland-Morris questionnaire. Spine (Phila Pa 1976). 2002 Mar 1;27(5):538-42. doi: 10.1097/00007632-200203010-00016.

  PMID: 11880841 BACKGROUND

• Bijur PE, Silver W, Gallagher EJ. Reliability of the visual analog scale for measurement of acute pain. Acad Emerg Med. 2001 Dec;8(12):1153-7. doi: 10.1111/j.1553-2712.2001.tb01132.x.

  PMID: 11733293 BACKGROUND

• Moreau CE, Green BN, Johnson CD, Moreau SR. Isometric back extension endurance tests: a review of the literature. J Manipulative Physiol Ther. 2001 Feb;24(2):110-22. doi: 10.1067/mmt.2001.112563.

  PMID: 11208223 BACKGROUND

• Ito T, Shirado O, Suzuki H, Takahashi M, Kaneda K, Strax TE. Lumbar trunk muscle endurance testing: an inexpensive alternative to a machine for evaluation. Arch Phys Med Rehabil. 1996 Jan;77(1):75-9. doi: 10.1016/s0003-9993(96)90224-5.

  PMID: 8554479 BACKGROUND

• Starkweather AR, Heineman A, Storey S, Rubia G, Lyon DE, Greenspan J, Dorsey SG. Methods to measure peripheral and central sensitization using quantitative sensory testing: A focus on individuals with low back pain. Appl Nurs Res. 2016 Feb;29:237-41. doi: 10.1016/j.apnr.2015.03.013. Epub 2015 Apr 8.

  PMID: 26856520 BACKGROUND

• Catley MJ, Tabor A, Wand BM, Moseley GL. Assessing tactile acuity in rheumatology and musculoskeletal medicine--how reliable are two-point discrimination tests at the neck, hand, back and foot? Rheumatology (Oxford). 2013 Aug;52(8):1454-61. doi: 10.1093/rheumatology/ket140. Epub 2013 Apr 22.

  PMID: 23611918 BACKGROUND

• Duncan PW, Weiner DK, Chandler J, Studenski S. Functional reach: a new clinical measure of balance. J Gerontol. 1990 Nov;45(6):M192-7. doi: 10.1093/geronj/45.6.m192.

  PMID: 2229941 BACKGROUND

• Newton RA. Validity of the multi-directional reach test: a practical measure for limits of stability in older adults. J Gerontol A Biol Sci Med Sci. 2001 Apr;56(4):M248-52. doi: 10.1093/gerona/56.4.m248.

  PMID: 11283199 BACKGROUND

• Coldwells A, Atkinson G, Reilly T. Sources of variation in back and leg dynamometry. Ergonomics. 1994 Jan;37(1):79-86. doi: 10.1080/00140139408963625.

  PMID: 8112285 BACKGROUND

• Azevedo DC, Lauria AC, Pereira AR, Andrade GT, Ferreira ML, Ferreira PH, Van Dillen L. Intraexaminer and interexaminer reliability of pressure biofeedback unit for assessing lumbopelvic stability during 6 lower limb movement tests. J Manipulative Physiol Ther. 2013 Jan;36(1):33-43. doi: 10.1016/j.jmpt.2012.12.008.

  PMID: 23380212 BACKGROUND

• Saur PM, Ensink FB, Frese K, Seeger D, Hildebrandt J. Lumbar range of motion: reliability and validity of the inclinometer technique in the clinical measurement of trunk flexibility. Spine (Phila Pa 1976). 1996 Jun 1;21(11):1332-8. doi: 10.1097/00007632-199606010-00011.

  PMID: 8725925 BACKGROUND

• Kolber MJ, Pizzini M, Robinson A, Yanez D, Hanney WJ. The reliability and concurrent validity of measurements used to quantify lumbar spine mobility: an analysis of an iphone(R) application and gravity based inclinometry. Int J Sports Phys Ther. 2013 Apr;8(2):129-37.

  PMID: 23593551 BACKGROUND

• Plisky PJ, Gorman PP, Butler RJ, Kiesel KB, Underwood FB, Elkins B. The reliability of an instrumented device for measuring components of the star excursion balance test. N Am J Sports Phys Ther. 2009 May;4(2):92-9.

  PMID: 21509114 BACKGROUND

• Garcia Campayo J, Rodero B, Alda M, Sobradiel N, Montero J, Moreno S. [Validation of the Spanish version of the Pain Catastrophizing Scale in fibromyalgia]. Med Clin (Barc). 2008 Oct 18;131(13):487-92. doi: 10.1157/13127277. Spanish.

  PMID: 19007576 BACKGROUND

• Gomez-Perez L, Lopez-Martinez AE, Ruiz-Parraga GT. Psychometric Properties of the Spanish Version of the Tampa Scale for Kinesiophobia (TSK). J Pain. 2011 Apr;12(4):425-35. doi: 10.1016/j.jpain.2010.08.004.

  PMID: 20926355 BACKGROUND

• Herrero R, Espinoza M, Molinari G, Etchemendy E, Garcia-Palacios A, Botella C, Banos RM. Psychometric properties of the General Self Efficacy-12 Scale in Spanish: general and clinical population samples. Compr Psychiatry. 2014 Oct;55(7):1738-43. doi: 10.1016/j.comppsych.2014.05.015. Epub 2014 May 28.

  PMID: 24973225 BACKGROUND

MeSH Terms

Conditions

Low Back Pain; Motor Activity

Interventions

Musculoskeletal Manipulations

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Central Study Contacts

Roy A La Touche, physiotherapist

CONTACT

917401980; roylatouche@lasallecampus.es

Mónica A Grande, physiotherapist

CONTACT

660638251; monica.grande@irflasalle.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Centro Superior de Estudios Universitarios La Salle (Universidad Autónoma de Madrid)

Study Record Dates

• First Submitted: May 9, 2017
• First Posted: June 9, 2017
• Study Start: September 1, 2017
• Primary Completion: December 29, 2018
• Study Completion: May 30, 2019
• Last Updated: September 6, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)