Manipulative Therapy Techniques to Treat Chronic Low Back Pain
3 de outubro de 2015 atualizado por: Adelaida María Castro-Sánchez, Universidad de Almeria
Short-term Effect of Manipulative Therapy Techniques in People With Chronic Low Back Pain: A Randomized Controlled Trial.
The purpose of this study is to analyze the effectiveness of a three manipulative therapy techniques in People with Chronic Low Back Pain.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Objective: To analyze the effectiveness of a three manipulative therapy techniques in individuals with chronic non-specific low back pain of mechanical etiology.
Design: Randomized clinical trial. Setting: Almeria, South Spain. Participants: Sixty two with chronic non-specific low back pain will be randomly assigned to an experimental or control group.
Intervention: For 3-week, the experimental group will undergo treatment comprising 3 sessions (1/week) of manipulative therapy techniques in the lumbar and sacral areas, and the control group will receive a functional technique in the lumbar area.
Main Outcome Measures: Oswestry disability index, pain visual analogue scale, Tampa scale for kinesiophobia, Roland-Morris disability questionnaire, McQuade test, quality of life scores and the range of trunk anteflexion motion, which were all assessed before the treatment and immediately after the last treatment session.
The primary outcome measure is the change in the RMDQ score at the end of the 3 weeks study period. A difference of 2.5 point is considered to be the minimum clinically important difference in the RMDQ score. A sample size of 62 patients (31 per group) would enable detection of a 2.5 point difference between groups given 80-90% power, a 5% (two-tailed) significance level, and a conservative standard derivation of 5 points. Key baseline demographic variables and clinical measure scores will be compared between groups by using independent Student t tests for continuous data and chi-square tests for categorical data. Separate 2x2 mixed model ANOVA with repeated measurements for the time factor need to be conducted in order to test between-groups differences in visual analogue scale, McQuade test, range of trunk anteflexion motion, Oswestry disability index, Roland Morris disability questionnaire, Tampa scale for kinesiophobia, and quality of life as the dependent variables, with group (functional technique or three manipulative therapy techniques) as the between subjects variable and time (baseline, post-treatment). A paired t-test will perform to test within-group differences in score changes from pre- to post-treatment. Effect size will test using Cohen's d. p = 0.05 will be considered significant in all tests.
Tipo de estudo
Intervencional
Inscrição (Real)
62
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Almeria, Espanha, 04120
- Adelaida María Castro-Sánchez
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
25 anos a 55 anos (Adulto)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- Low back pain for ≥ 3 months.
- Score ≥4 on the Roland Morris disability questionnaire.
- No undergoing another physical therapy treatment.
- Inability to achieve lumbar muscle flexion-relaxation in trunk flexion
Exclusion Criteria:
- Clinical signs of radiculopathy.
- Presence of lumbar stenosis.
- Fibromyalgia.
- Spondylolisthesis.
- History of spinal surgery.
- Treatment with corticosteroids in the past two weeks.
- Disease of the central or peripheral nervous system.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Experimental: Manipulative Therapy Techniques
Manipulative Therapy Techniques involve three techniques on lumbar and sacral areas.
This protocol will be administered one a week for 3 weeks.
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Comparador Ativo: Functional Technique
Manipulative Therapy Technique involves one technique on lumbar area.
This protocol will be administered one a week for 3 weeks.
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The therapist presses the two anterior superior iliac spines to open the back of the pelvis, this maintained throughout the technique.
Then patient is asked to breathe deeply and exhale, sacrum makes a flexion-extension respectively.
These movements should be symmetrical and of equal duration in time.
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Roland Morris Disability Questionnaire (RMDQ)
Prazo: At baseline, 3 weeks and 7 weeks
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The Roland Morris disability questionnaire is a self-administered disability measurement scored on a 24-point scale from 0 = no disability to 24 = severe disability.
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At baseline, 3 weeks and 7 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
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Oswestry Disability Index (ODI)
Prazo: At baseline, 3 weeks and 7 weeks
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The Oswestry disability index evaluates daily life activity limitations in 10 dimensions, each scored on a 6-point scale (0-5 points); the total points scored are expressed as a percentage, used to classify individuals as minimally disabled (0-10%), moderately disabled (20-40%), severely disabled (40-60%), crippled (60-80%), or bedbound (80-100%).
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At baseline, 3 weeks and 7 weeks
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Visual Analogue Scale (VAS)
Prazo: At baseline, 3 weeks and 7 weeks
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The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
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At baseline, 3 weeks and 7 weeks
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Tampa Scale for Kinesiophobia (TSK)
Prazo: At baseline, 3 weeks and 7 weeks
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The Tampa Scale for Kinesiophobia comprises 17 items on the fear of movement or recurrent lesion, each scored on a 4-point Likert scale from "completely disagree" to "completely agree".
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At baseline, 3 weeks and 7 weeks
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Quality of Life
Prazo: At baseline, 3 weeks and 7 weeks
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SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
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At baseline, 3 weeks and 7 weeks
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Isometric Resistance of Abdominal Muscles
Prazo: At baseline, 3 weeks and 7 weeks
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The McQuade test measures the isometric resistance of abdominal muscles in seconds.
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At baseline, 3 weeks and 7 weeks
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Lumbar Mobility in Flexion
Prazo: At baseline, 3 weeks and 7 weeks
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Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
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At baseline, 3 weeks and 7 weeks
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Adelaida M Castro-Sánchez, PhD, Universidad de Almeria
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low-back pain. Cochrane Database Syst Rev. 2012 Sep 12;2012(9):CD008880. doi: 10.1002/14651858.CD008880.pub2.
- Tozzi P, Bongiorno D, Vitturini C. Low back pain and kidney mobility: local osteopathic fascial manipulation decreases pain perception and improves renal mobility. J Bodyw Mov Ther. 2012 Jul;16(3):381-391. doi: 10.1016/j.jbmt.2012.02.001. Epub 2012 Mar 3.
- Falco FJ, Manchikanti L, Datta S, Sehgal N, Geffert S, Onyewu O, Zhu J, Coubarous S, Hameed M, Ward SP, Sharma M, Hameed H, Singh V, Boswell MV. An update of the effectiveness of therapeutic lumbar facet joint interventions. Pain Physician. 2012 Nov-Dec;15(6):E909-53.
- Licciardone JC, Kearns CM. Somatic dysfunction and its association with chronic low back pain, back-specific functioning, and general health: results from the OSTEOPATHIC Trial. J Am Osteopath Assoc. 2012 Jul;112(7):420-8.
- Cook C, Learman K, Showalter C, Kabbaz V, O'Halloran B. Early use of thrust manipulation versus non-thrust manipulation: a randomized clinical trial. Man Ther. 2013 Jun;18(3):191-8. doi: 10.1016/j.math.2012.08.005. Epub 2012 Oct 2.
- Schafer A, Gartner-Tschacher N, Schottker-Koniger T. [Subgroup-specific therapy of low back pain: description and validity of two classification systems]. Orthopade. 2013 Feb;42(2):90-9. doi: 10.1007/s00132-012-2041-5. German.
- Rodeghero JR, Denninger TR, Ross MD. Abdominal pain in physical therapy practice: 3 patient cases. J Orthop Sports Phys Ther. 2013 Feb;43(2):44-53. doi: 10.2519/jospt.2013.4408. Epub 2013 Jan 14. Erratum In: J Orthop Sports Phys Ther. 2013 Feb;43(2):196.
- Muir JM. Partial lumbosacral transitional vertebrae: 2 cases of unilateral sacralization. J Chiropr Med. 2012 Jun;11(2):77-83. doi: 10.1016/j.jcm.2011.12.002.
- Shum GL, Tsung BY, Lee RY. The immediate effect of posteroanterior mobilization on reducing back pain and the stiffness of the lumbar spine. Arch Phys Med Rehabil. 2013 Apr;94(4):673-9. doi: 10.1016/j.apmr.2012.11.020. Epub 2012 Nov 23.
- Williams JM, Haq I, Lee RY. The effect of pain relief on dynamic changes in lumbar curvature. Man Ther. 2013 Apr;18(2):149-54. doi: 10.1016/j.math.2012.09.004. Epub 2012 Oct 9.
- Williams JM, Haq I, Lee RY. A novel approach to the clinical evaluation of differential kinematics of the lumbar spine. Man Ther. 2013 Apr;18(2):130-5. doi: 10.1016/j.math.2012.08.003. Epub 2012 Oct 6.
- Hendrick P, Mani R, Bishop A, Milosavljevic S, Schneiders AG. Therapist knowledge, adherence and use of low back pain guidelines to inform clinical decisions--a national survey of manipulative and sports physiotherapists in New Zealand. Man Ther. 2013 Apr;18(2):136-42. doi: 10.1016/j.math.2012.09.002. Epub 2012 Oct 6.
- Carlsson H, Rasmussen-Barr E. Clinical screening tests for assessing movement control in non-specific low-back pain. A systematic review of intra- and inter-observer reliability studies. Man Ther. 2013 Apr;18(2):103-10. doi: 10.1016/j.math.2012.08.004. Epub 2012 Sep 25.
- Marlowe D. Complementary and alternative medicine treatments for low back pain. Prim Care. 2012 Sep;39(3):533-46. doi: 10.1016/j.pop.2012.06.008. Epub 2012 Jul 30.
- Guild DG. Mechanical therapy for low back pain. Prim Care. 2012 Sep;39(3):511-6. doi: 10.1016/j.pop.2012.06.006.
- Balthazard P, de Goumoens P, Rivier G, Demeulenaere P, Ballabeni P, Deriaz O. Manual therapy followed by specific active exercises versus a placebo followed by specific active exercises on the improvement of functional disability in patients with chronic non specific low back pain: a randomized controlled trial. BMC Musculoskelet Disord. 2012 Aug 28;13:162. doi: 10.1186/1471-2474-13-162.
- Tufo A, Desai GJ, Cox WJ. Psoas syndrome: a frequently missed diagnosis. J Am Osteopath Assoc. 2012 Aug;112(8):522-8. doi: 10.7556/jaoa.2012.112.8.522.
- Peterson CK, Bolton J, Humphreys BK. Predictors of improvement in patients with acute and chronic low back pain undergoing chiropractic treatment. J Manipulative Physiol Ther. 2012 Sep;35(7):525-33. doi: 10.1016/j.jmpt.2012.06.003. Epub 2012 Jul 31.
- Mazaheri M, Coenen P, Parnianpour M, Kiers H, van Dieen JH. Low back pain and postural sway during quiet standing with and without sensory manipulation: a systematic review. Gait Posture. 2013 Jan;37(1):12-22. doi: 10.1016/j.gaitpost.2012.06.013. Epub 2012 Jul 15.
- Alpert BS. Exercise in sickle cell anemia. Pediatr Cardiol. 1990 Oct;11(4):227. doi: 10.1007/BF02238375. No abstract available.
- Vora RN, Barron BA, Almudevar A, Utell MJ. Work-related chronic low back pain-return-to-work outcomes after referral to interventional pain and spine clinics. Spine (Phila Pa 1976). 2012 Sep 15;37(20):E1282-9. doi: 10.1097/BRS.0b013e318265a930.
- Vismara L, Cimolin V, Menegoni F, Zaina F, Galli M, Negrini S, Villa V, Capodaglio P. Osteopathic manipulative treatment in obese patients with chronic low back pain: a pilot study. Man Ther. 2012 Oct;17(5):451-5. doi: 10.1016/j.math.2012.05.002. Epub 2012 May 31.
- Hansen H, Manchikanti L, Simopoulos TT, Christo PJ, Gupta S, Smith HS, Hameed H, Cohen SP. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician. 2012 May-Jun;15(3):E247-78.
- Day JM, Nitz AJ. The effect of muscle energy techniques on disability and pain scores in individuals with low back pain. J Sport Rehabil. 2012 May;21(2):194-8. doi: 10.1123/jsr.21.2.194.
- Cohen BL. Emerging technologies in the field of healthcare: enhancing the interface to the medical professional. Ann Acad Med Singap. 1990 Sep;19(5):627-39.
- Parker J, Heinking KP, Kappler RE. Efficacy of osteopathic manipulative treatment for low back pain in euhydrated and hypohydrated conditions: a randomized crossover trial. J Am Osteopath Assoc. 2012 May;112(5):276-84.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de março de 2013
Conclusão Primária (Real)
1 de outubro de 2013
Conclusão do estudo (Real)
1 de novembro de 2013
Datas de inscrição no estudo
Enviado pela primeira vez
20 de fevereiro de 2013
Enviado pela primeira vez que atendeu aos critérios de CQ
20 de fevereiro de 2013
Primeira postagem (Estimativa)
21 de fevereiro de 2013
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
6 de outubro de 2015
Última atualização enviada que atendeu aos critérios de controle de qualidade
3 de outubro de 2015
Última verificação
1 de novembro de 2013
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UAL-1
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