Clinical trial NCT04082065: Cyriax Manipulation in Lumbar Derangement Syndrome
Official title: Cyriax Manipulation in Lumbar Internal Derangement Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Derangement; Low Back
Keywords: Conventional physical therapy(CPT)
.Low back pain (LBP),
Oswestery disability index (ODI),
Quality of life (QOL),
Range of motion (ROM)
Visual analogue scale (VAS)
Lead sponsor: Riphah International University
Sponsor class: OTHER
First posted: 2019-09-09
Enrollment: 43
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: interventional
Primary purpose: OTHER

Brief summary: the objective of the study was to determine the effect of Cyriax manipulation for Pain, range of motion and quality of life in lumbar internal derangement radiculopathy in single physical therapy session. Randomized control trails were carried out in Railway general hospital from February 2018 to July 2018 in which 43 patients with Low back pain were randomly divided by lottery method into control and experimental group. Single session of treatment was given. tools used in the study are visual analog scale, Oswestry disability index and lumber range of motion. data was analysed through SPSS (statistical package for social sciences) 21.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Owstery disability index
timeFrame: 3rd day
Secondary outcomes:
measure: visual analog sclae
timeFrame: 1st day after session
measure: range of motion lumber spine (flexion)
timeFrame: 1st day after session
measure: range of motion lumber spine (extension)
timeFrame: 1st day after session
measure: range of motion lumber spine (right side bending)
timeFrame: 1st day after session
measure: range of motion lumber spine (left side bending)
timeFrame: 1st day after session
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Riphah International university
state: Federal
Study officials:
affiliation: Riphah International University
name: Abdul Ghafoor Sajjad, PHD*
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: Lidgren L. The bone and joint decade 2000-2010. Bull World Health Organ. 2003;81(9):629. Epub 2003 Nov 14. No abstract available.
citation: 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.
citation: 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.
citation: Ombregt L. A System of Orthopaedic Medicine-E-Book: Elsevier Health Sciences; 2013.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.