Manipulative Therapy Techniques to Treat Chronic Low Back Pain
3 oktober 2015 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Ingrijpend
Inschrijving (Werkelijk)
62
Fase
- Niet toepasbaar
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
-
-
-
Almeria, Spanje, 04120
- Adelaida María Castro-Sánchez
-
-
Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
25 jaar tot 55 jaar (Volwassen)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
|
Experimenteel: 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.
|
|
|
Actieve vergelijker: Functional Technique
Manipulative Therapy Technique involves one technique on lumbar area.
This protocol will be administered one a week for 3 weeks.
|
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.
|
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Roland Morris Disability Questionnaire (RMDQ)
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
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.
|
At baseline, 3 weeks and 7 weeks
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Oswestry Disability Index (ODI)
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
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%).
|
At baseline, 3 weeks and 7 weeks
|
|
Visual Analogue Scale (VAS)
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
The visual analogue scale for pain intensity ranged from 0 = no pain to 10 = worst imaginable pain.
|
At baseline, 3 weeks and 7 weeks
|
|
Tampa Scale for Kinesiophobia (TSK)
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
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".
|
At baseline, 3 weeks and 7 weeks
|
|
Quality of Life
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
SF-36 Health Questionnaire scores range from 0 to 100% and indicate the self-perceived health-related quality of life.
|
At baseline, 3 weeks and 7 weeks
|
|
Isometric Resistance of Abdominal Muscles
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
The McQuade test measures the isometric resistance of abdominal muscles in seconds.
|
At baseline, 3 weeks and 7 weeks
|
|
Lumbar Mobility in Flexion
Tijdsspanne: At baseline, 3 weeks and 7 weeks
|
Lumbar mobility in flexion was determined by measuring the distance from the tip of the third finger to the floor with a tape measure.
|
At baseline, 3 weeks and 7 weeks
|
Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Onderzoekers
- Studie directeur: Adelaida M Castro-Sánchez, PhD, Universidad de Almeria
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 maart 2013
Primaire voltooiing (Werkelijk)
1 oktober 2013
Studie voltooiing (Werkelijk)
1 november 2013
Studieregistratiedata
Eerst ingediend
20 februari 2013
Eerst ingediend dat voldeed aan de QC-criteria
20 februari 2013
Eerst geplaatst (Schatting)
21 februari 2013
Updates van studierecords
Laatste update geplaatst (Schatting)
6 oktober 2015
Laatste update ingediend die voldeed aan QC-criteria
3 oktober 2015
Laatst geverifieerd
1 november 2013
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- UAL-1
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .