Derangement; Low BackNCT04082065
Cyriax Manipulation in Lumbar Derangement Syndrome
A study testing conventional physical therapy and cyriax lumber manipulation group in people with Derangement; Low Back, run by Riphah International University at 1 site in Pakistan.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 50 years, women only
- Conditions the study is for
- Derangement; Low Back
- What is being tested?
- conventional physical therapy and cyriax lumber manipulation group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2018to 30 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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 .
Who cannot join
- Osteoporosis of hip, Bilateral sciatica, having anticoagulant medication, pregnancy, patient with impaired mental status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cyriax Manipulation in Lumbar Internal Derangement Syndrome
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.
Read the 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.
- Conditions
- Derangement; Low Back
- Being tested
- conventional physical therapy, cyriax lumber manipulation group
- 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)
- Medical subject headings
- Low Back Pain, Hypotension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
conventional physical therapyOther
hot pack for 15 minutes Myofacial release (10 minutes) and Stretching of hamstrings and Piriformis (5 reps each with 2 second hold)
cyriax lumber manipulation groupOther
Hot Pack, Myofacial Release, stretching of hamstrings and Piriformis (five reps each with 2 seconds hold) and Cyriax Lumbar Manipulation Techniques
| Study group | Role | What they receive |
|---|---|---|
| conventional physical therapy | Active comparator | Myofacial release Stretching of hamstring and Piriformis Receives: Other: conventional physical therapy |
| cyriax lumber manipulation group | Experimental | Myofacial Release stretching of hamstrings and Piriformis Cyriax Lumbar Manipulation Techniques Receives: Other: cyriax lumber manipulation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Owstery disability index
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
Measured: 3rd day
Secondary outcomes (5)
visual analog sclae
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
Measured: 1st day after session
range of motion lumber spine (flexion)
changes from baseline lumber flexion range of motion was taken by the help of goniometer
Measured: 1st day after session
range of motion lumber spine (extension)
changes from baseline lumber range of motion was taken by the help of goniometer
Measured: 1st day after session
range of motion lumber spine (right side bending)
changes from baseline lumber range of motion was taken by the help of goniometer
Measured: 1st day after session
range of motion lumber spine (left side bending)
changes from baseline lumber range of motion was taken by the help of goniometer
Measured: 1st day after session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2019
- Study start15 Jan 2018
- Primary completion20 Jun 2018
- Study completion30 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Derangement; Low BackStudies of the same condition, open and under way.
- More trials run by Riphah International UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- interventional
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Riphah International University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdul Ghafoor Sajjad, PHD*, Principal investigator, Riphah International University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04082065
- Sponsor's protocol ID
- RiphahIU Sara yasin
- Status last verified
- Sep 2019
- First submitted
- 5 Sep 2019
- Last updated
- 13 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 14679827Katz 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.
PubMed 16595438Punnett 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.
PubMed 16299708Lidgren L. The bone and joint decade 2000-2010. Bull World Health Organ. 2003;81(9):629. Epub 2003 Nov 14. No abstract available.
PubMed 14710501Dionne 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.
PubMed 16547119Ernst 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.
PubMed 16574972Ombregt 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.
PubMed 23169072Assendelft 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.
PubMed 12779297Aure 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.
PubMed 12642755Wand 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.
PubMed 15507794McMorland 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.
PubMed 21036279Muller 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.
PubMed 15726029Bialosky 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.
PubMed 19797305
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cyriax Manipulation in Lumbar Internal Derangement Syndrome
- ClinicalTrials.gov ID
- NCT04082065
- Acronym / sponsor ID
- RiphahIU Sara yasin
- 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)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Riphah International UniversityUniversity, hospital or other
- Study start
- 15 Jan 2018 (actual)
- Primary completion
- 20 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 9 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- interventional
| Arm | Type | Receives |
|---|---|---|
| conventional physical therapy | Active comparator | Other: conventional physical therapyMyofacial release Stretching of hamstring and Piriformis |
| cyriax lumber manipulation group | Experimental | Other: cyriax lumber manipulation groupMyofacial Release stretching of hamstrings and Piriformis Cyriax Lumbar Manipulation Techniques |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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 .
Key exclusion criteria (1 listed)
- Osteoporosis of hip, Bilateral sciatica, having anticoagulant medication, pregnancy, patient with impaired mental status
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| conventional physical therapyhot pack for 15 minutes Myofacial release (10 minutes) and Stretching of hamstrings and Piriformis (5 reps each with 2 second hold) | Other | conventional physical therapy |
| cyriax lumber manipulation groupHot Pack, Myofacial Release, stretching of hamstrings and Piriformis (five reps each with 2 seconds hold) and Cyriax Lumbar Manipulation Techniques | Other | cyriax lumber manipulation group |
Primary outcome
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
5 secondary outcomes
visual analog sclae
Time frame: 1st day after session
range of motion lumber spine (flexion)
Time frame: 1st day after session
range of motion lumber spine (extension)
Time frame: 1st day after session
range of motion lumber spine (right side bending)
Time frame: 1st day after session
range of motion lumber spine (left side bending)
Time frame: 1st day after session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2019.
- Background: PubMed 14679827WHO 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.
- Background: PubMed 16595438Katz 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.
- Background: PubMed 16299708Punnett 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.
- Background: PubMed 14710501Lidgren L. The bone and joint decade 2000-2010. Bull World Health Organ. 2003;81(9):629. Epub 2003 Nov 14. No abstract available.
- Background: PubMed 16547119Dionne 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.
- Background: PubMed 16574972Ernst 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.
- BackgroundOmbregt L. A System of Orthopaedic Medicine-E-Book: Elsevier Health Sciences; 2013.
- Background: PubMed 23169072Rubinstein 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.
- Background: PubMed 12779297Assendelft 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.
- Background: PubMed 12642755Aure 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.
- Background: PubMed 15507794Wand 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.
- Background: PubMed 21036279McMorland 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.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdul Ghafoor Sajjad, PHD* principal investigator
Riphah International University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing conventional physical therapy and cyriax lumber manipulation group in people with Derangement; Low Back, run by Riphah International University at 1 site in Pakistan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Owstery disability index (time frame: 3rd day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04082065, which also lists 14 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2019.