- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04082065
Cyriax Manipulation in Lumbar Derangement Syndrome
Cyriax Manipulation in Lumbar Internal Derangement Syndrome
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Human spine is a supporting structure of skeleton consisting of four curves cervical (lordosis), thoracic (kyphosis) , lumbar(lordosis) and sacrococcygeal (kyphosis). Cervical and lumbar being primary contributes for erect posture. Lumbar spine (lordotic curve) is the area of lower back of spine consisting of five vertebrae L1-L5 extending between thoracic and sacrum to accommodate progressively increasing loads.it is connected to pelvis where most weight bearing and body movement takes place. Over the last few decades, low-back pain has become increasingly problematic, placing significant burdens on economy and health system.the 2019 Global burden of Disease study estimated that low back pain is among the top ten diseases. low back pain is common that only a minority of individuals escape it. Eighty percent of anatomical and degenerative changes cause pain in lower back area .low back pain is extremely common having complex causes, may be acute sub-acute or chronic in nature depending upon severity of onset cause. Large forces acts on lumbar spine during functional activities such as lifting, running, walking and twisting causes repetitive micro traumas leading to low back pain which is distressing feelings.low back pain can be dull ache, shooting pain or burning sensation in nature originating from neuro-vascular, vertebral bones,facet joints or other vertebral structures. Low back pain which begin under 12th rib and on top of the inferior gluteal lines involving one or both lower extremities is called radiating low back pain which can be due to any internal derangement in anatomical structures of vertebral column. Internal derangement is disturbance of the regular order or arrangement of joint in which normal resting position of the articular surfaces of two adjacent vertebrae is disturbed as a result of a change in the position of fluid mechanics of disc, joint structure, ligaments, vascular and neuro-muscular system of lumbar spine due to mechanical or non mechanical stresses.Clinically lumbar internal derangement syndromes are .classified into mechanical and non mechanical based on origin internal derangement is disturbance of the regular order or arrangement of joint in which normal resting position of articular surfaces of two adjacent vertebrae is disturbed as a result of a change in position of fluid mechanics of disc, joint structures, ligaments, vascular and neuro-muscular system of lumbar spine due to mechanical or non mechanical stresses. Clinically lumbar internal derangement syndrome are classified into mechanical and non mechanical based on origin.Non mechanical internal derangement syndromes are due to non activity related disorders affecting spine such as inflammatory diseases (septic and hematological), tumors and infiltration lesions, metabolic disorders and acquired defects in neural arch whereas mechanical derangements are caused by placing abnormal stress on lower back disrupting normal order of lumbar spine anatomy. Physiotherapy treatments for low back pain includes myofascial release trigger point release, stretching of culprit muscles(hamstrings, lumbar erector spinae ,multifidus and piriformis), mobilization of vertebrae, traction of lumbar spine and Manipulation of lumbar spine (cyriax Manipulations, Osteopathic Manipulations and Chiropractor Manipulations).
Manipulations is passive movements carried out by clinician with single thrust high velocity, low amplitude or sustained pressure not under control of patient in order to return displacement to its proper position.Manipulations are used to reduce pain and disability caused by any internal derangement and intervertebral cartilaginous structure. Manipulations are based on different theories of which reduction of disc protrusions, correction of posterior joint dysfunction, mobilization of blocked vertebral joints and reduction of nerve root compression are some of them.
In 2012 John J Kuczynski conducted a systematic review on effectiveness of spinal manipulation therapy for treatment of chronic low back pain literature extracted from different data base concluded that spinal manipulations are safe and have significant clinical outcomes. A study published on 17th May 2018 on spinal manipulation in treatment of patient with MRI diagnosed lumbar disc herniation and sacroiliac hypermobility by Esmael Shokri et al concluded that lumbar and Sacro-iliac joint manipulations have significant effect on pain potential and disability. In March 2006 Muhammad A. Mohseni Bandpelet conducted randomized control trial study on spinal manipulation and ultrasound therapy in treatment of chronic low back pain. One hundred and twenty people were randomly allocated into manipulative group and ultrasound therapy group.They concluded that patient who received manipulative therapy showed greater decrease in pain intensity with increased spinal range of motions and functional qualities.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Federal
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Islamabad, Federal, Pakistan, 44000
- Riphah International University
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- lumber pain, pain radiating to leg, motor deficits in legs, , dural signs and symptoms, impaired nerve root mobility(straight leg raise and L3 stretch), back pain effecting Quality of life, ODI score less than 30 and Limited range of motion .
Exclusion Criteria:
- Osteoporosis of hip, Bilateral sciatica, having anticoagulant medication, pregnancy, patient with impaired mental status
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: conventional physical therapy
Myofacial release Stretching of hamstring and Piriformis
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hot pack for 15 minutes Myofacial release (10 minutes) and Stretching of hamstrings and Piriformis (5 reps each with 2 second hold)
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Experimental: cyriax lumber manipulation group
Myofacial Release stretching of hamstrings and Piriformis Cyriax Lumbar Manipulation Techniques
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Hot Pack, Myofacial Release, stretching of hamstrings and Piriformis (five reps each with 2 seconds hold) and Cyriax Lumbar Manipulation Techniques
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Owstery disability index
Time Frame: 3rd day
|
ODI is self-reported tool used widely for measurement of functional disability related to.
It was introduced by Fairbank et al in 1980 which gives guidelines for measuring functional disability due to LBP and considered gold standard.
It is divided into 10 sections i.e. pain, personal care, sitting, walking, standing, travelling, weight lifting, sleeping, social life.
Patient is guided to select one option according to their symptoms.
Total score is 50.Once the individual score is calculated Percentage can be calculated by dividing it with total score i.e.
50 and then multiply it by 100.)
In This study scores are calculated by filling the questionnaire before session and then filling it after two or three days after
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3rd day
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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visual analog sclae
Time Frame: 1st day after session
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Visual Analogue Scale is an instrument used for measurement of characteristics that are in continuum manner and cannot be directly measured e.g.
pain .it is simple and most widely used measurement for pain variations VAS is a horizontal line of 100 mm.
Patient is asked to mark a point of their current status .it
has 5-point description "nil" Mild'" moderate" "severe" and "very severe
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1st day after session
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range of motion lumber spine (flexion)
Time Frame: 1st day after session
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changes from baseline lumber flexion range of motion was taken by the help of goniometer
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1st day after session
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range of motion lumber spine (extension)
Time Frame: 1st day after session
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changes from baseline lumber range of motion was taken by the help of goniometer
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1st day after session
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range of motion lumber spine (right side bending)
Time Frame: 1st day after session
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changes from baseline lumber range of motion was taken by the help of goniometer
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1st day after session
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range of motion lumber spine (left side bending)
Time Frame: 1st day after session
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changes from baseline lumber range of motion was taken by the help of goniometer
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1st day after session
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Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Aure OF, Nilsen JH, Vasseljen O. Manual therapy and exercise therapy in patients with chronic low back pain: a randomized, controlled trial with 1-year follow-up. Spine (Phila Pa 1976). 2003 Mar 15;28(6):525-31; discussion 531-2. doi: 10.1097/01.BRS.0000049921.04200.A6.
- Katz JN. Lumbar disc disorders and low-back pain: socioeconomic factors and consequences. J Bone Joint Surg Am. 2006 Apr;88 Suppl 2:21-4. doi: 10.2106/JBJS.E.01273.
- WHO Scientific Group on the Burden of Musculoskeletal Conditions at the Start of the New Millennium. The burden of musculoskeletal conditions at the start of the new millennium. World Health Organ Tech Rep Ser. 2003;919:i-x, 1-218, back cover.
- Punnett L, Pruss-Utun A, Nelson DI, Fingerhut MA, Leigh J, Tak S, Phillips S. Estimating the global burden of low back pain attributable to combined occupational exposures. Am J Ind Med. 2005 Dec;48(6):459-69. doi: 10.1002/ajim.20232.
- Lidgren L. The bone and joint decade 2000-2010. Bull World Health Organ. 2003;81(9):629. Epub 2003 Nov 14. No abstract available.
- Dionne CE, Dunn KM, Croft PR. Does back pain prevalence really decrease with increasing age? A systematic review. Age Ageing. 2006 May;35(3):229-34. doi: 10.1093/ageing/afj055. Epub 2006 Mar 17.
- Ernst E, Canter PH. A systematic review of systematic reviews of spinal manipulation. J R Soc Med. 2006 Apr;99(4):192-6. doi: 10.1177/014107680609900418.
- Ombregt L. A System of Orthopaedic Medicine-E-Book: Elsevier Health Sciences; 2013.
- Rubinstein SM, Terwee CB, Assendelft WJ, de Boer MR, van Tulder MW. Spinal manipulative therapy for acute low back pain: an update of the cochrane review. Spine (Phila Pa 1976). 2013 Feb 1;38(3):E158-77. doi: 10.1097/BRS.0b013e31827dd89d.
- Assendelft WJ, Morton SC, Yu EI, Suttorp MJ, Shekelle PG. Spinal manipulative therapy for low back pain. A meta-analysis of effectiveness relative to other therapies. Ann Intern Med. 2003 Jun 3;138(11):871-81. doi: 10.7326/0003-4819-138-11-200306030-00008.
- Wand BM, Bird C, McAuley JH, Dore CJ, MacDowell M, De Souza LH. Early intervention for the management of acute low back pain: a single-blind randomized controlled trial of biopsychosocial education, manual therapy, and exercise. Spine (Phila Pa 1976). 2004 Nov 1;29(21):2350-6. doi: 10.1097/01.brs.0000143619.34308.b4.
- McMorland G, Suter E, Casha S, du Plessis SJ, Hurlbert RJ. Manipulation or microdiskectomy for sciatica? A prospective randomized clinical study. J Manipulative Physiol Ther. 2010 Oct;33(8):576-84. doi: 10.1016/j.jmpt.2010.08.013.
- Muller R, Giles LG. Long-term follow-up of a randomized clinical trial assessing the efficacy of medication, acupuncture, and spinal manipulation for chronic mechanical spinal pain syndromes. J Manipulative Physiol Ther. 2005 Jan;28(1):3-11. doi: 10.1016/j.jmpt.2004.12.004.
- Bialosky JE, Bishop MD, Robinson ME, Zeppieri G Jr, George SZ. Spinal manipulative therapy has an immediate effect on thermal pain sensitivity in people with low back pain: a randomized controlled trial. Phys Ther. 2009 Dec;89(12):1292-303. doi: 10.2522/ptj.20090058. Epub 2009 Oct 1.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RiphahIU Sara yasin
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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