Chronic Low Back PainSpinMobNCT02645123

Gait in Low Back Pain Patients After Spinal Mobilization

A study testing TENS, spinal mobilization and swedish type massage in people with Chronic Low Back Pain, run by University of Ioannina.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 21 to 78 years
Conditions the study is for: Chronic Low Back Pain
What is being tested?: TENS, spinal mobilization and swedish type massage
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 75 participants
Where: No sites listed yet
Study dates: Dec 2011to Nov 2014
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 21 to 78 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

low back pain for over 3 months
recent lumbar MRI (up to 12 months)
able to walk without the need of walking aids

Who cannot join

leg length discrepancy of over 2 cm
history of spinal surgery
history of autoimmune disease
history of spondylolysis and spondylolisthesis
spinal fractures
pregnancy

Show all 14Show fewer

respiratory and/or cardiac disease
history of stroke
hip, knee or ankle osteoarthritis
cauda equina syndrome
spinal inflammation
spinal tumor
steroid drug use in the last month
osteoporosis

About this study

Official title: Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization

Introduction: patients with chronic back pain as a result of degenerated disc disease, besides pain also present with impaired gait. The purpose of this study is to evaluate both the clinical data using clinical rating scales, such as Oswestry Disability Index Greek version (ODI), Numerical Pain Rating Scale for low back pain and leg pain (NPRS) and the Roland Morris Disability Questionnaire Greek Version, and kinetic and kinematic characteristics during gait analysis in patients with chronic low back pain as a result of the degenerated disc disease (Disc Degenerative Disease), before and after application of manual therapy techniques.

Methodology: for the purposes of the study, 75 patients suffering from chronic low back pain were randomly divided into 3 groups of 25 each. Each group received five sessions with the first group receiving manual therapy treatment (spinal mobilisation), the second a sham treatment and the third, classic physiotherapy (stretching exercises, TENS and massage). To evaluate the effectiveness of each treatment, the visual analog pain scale, two questionnaires (Oswestry and Roland Morris) and also an optoelectronic system for recording and analysis of gait (kinetic and kinematic data) were utilized.

Read the detailed description

This was a randomized controlled trial comparing the efficacy of spinal mobilization with other physiotherapy interventions (stretching, TENS application and Swedish type massage) and sham treatment in a group of chronic low back pain patients. The outcome measures included three dimensional gait analysis (kinetic and kinematic data) as well as clinical indicators (numerical pain rating scale, Oswestry disability index, Roland-Moris Disability questionnaire).

Conditions: Chronic Low Back Pain
Being tested: TENS, spinal mobilization, swedish type massage, static hamstring stretch, sham treatment
Keywords: spinal mobilization, manual therapy, gait analysis, low back pain, chronic
Medical subject headings: Low Back Pain, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TENSDevice
Enraf-Nonius Sonopuls 692
spinal mobilizationProcedure or surgery
passive physiological intervertebral movements and passive accessory posteroanterior mobilization
swedish type massageProcedure or surgery
petrissage, effleurage, tapotement
static hamstring stretchProcedure or surgery
static hamstring stretching
sham treatmentProcedure or surgery
touching of the skin overlying the lumbar area

Study groups in NCT02645123
Study group	Role	What they receive
Spinal mobilization	Experimental	The individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration Receives: Procedure: spinal mobilization
Sham Treatment	Sham comparator	The investigator touched the skin overlying the low back statically for 10 minutes Receives: Procedure: sham treatment
Classic Physiotherapy	Active comparator	This group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading) Receives: Device: TENS; Procedure: swedish type massage; Procedure: static hamstring stretch

What is being measured

The primary outcome is the main question the study is designed to answer.

Change in the Numerical Pain Rating Scale
this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
Measured: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
Change in the Oswestry Low Back Pain Disability Index
this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points
Measured: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
Change in the Roland-Morris Disability Questionnaire
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain.
For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.
Measured: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F\&frmType=image\&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.
Measured: before the beginning and after the end of 5 weeks for each patient

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Nov 2014

First posted1 Jan 2016 (estimated)
Study startDec 2011
Primary completionOct 2014
Study completionNov 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (23)Papers the sponsor has linked to this study.
Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
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: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Participant
Enrolment: 75 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02645123
Sponsor's protocol ID: 721α/11-10-2011
Acronym: SpinMob
Status last verified: May 2017
First submitted: 23 Dec 2015
Last updated: 8 Jun 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: Yes: individual participant's grade of disc degeneration has been shared as an appendix in an already published article: http://dx.doi.org/10.1080/10669817.2016.1184435. Please note that no more IPD will be shared.

Publications

Goodsell M, Lee M, Latimer J. Short-term effects of lumbar posteroanterior mobilization in individuals with low-back pain. J Manipulative Physiol Ther. 2000 Jun;23(5):332-42.
PubMed 10863253
Managing chronic low back pain. How to avoid the problem, lower risk, and manage the discomfort when it occurs. Duke Med Health News. 2014 May;20(5):1-2. No abstract available.
PubMed 24960844
Goel A, Loudon J, Nazare A, Rondinelli R, Hassanein K. Joint moments in minor limb length discrepancy: a pilot study. Am J Orthop (Belle Mead NJ). 1997 Dec;26(12):852-6.
PubMed 9413588
Liu XC, Fabry G, Molenaers G, Lammens J, Moens P. Kinematic and kinetic asymmetry in patients with leg-length discrepancy. J Pediatr Orthop. 1998 Mar-Apr;18(2):187-9.
PubMed 9531400
McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. doi: 10.1136/bjsm.25.1.10.
PubMed 1913023
Kawaguchi Y, Matsui H, Tsuji H. Back muscle injury after posterior lumbar spine surgery. Part 2: Histologic and histochemical analyses in humans. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2598-602. doi: 10.1097/00007632-199411001-00018.
PubMed 7855687
Taylor H, McGregor AH, Medhi-Zadeh S, Richards S, Kahn N, Zadeh JA, Hughes SP. The impact of self-retaining retractors on the paraspinal muscles during posterior spinal surgery. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2758-62. doi: 10.1097/00007632-200212150-00004.
PubMed 12486343
Wang D, Bergstrom E, Clarke M, Henderson N, Gardner B. Mobility of the spine after spinal surgery in acute spinal cord injury. Spinal Cord. 2003 Nov;41(11):593-9. doi: 10.1038/sj.sc.3101528.
PubMed 14569260
O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
PubMed 9431633
Egerton T, Danoudis M, Huxham F, Iansek R. Central gait control mechanisms and the stride length - cadence relationship. Gait Posture. 2011 Jun;34(2):178-82. doi: 10.1016/j.gaitpost.2011.04.006. Epub 2011 May 7.
PubMed 21550245
Mello RG, Oliveira LF, Nadal J. Digital Butterworth filter for subtracting noise from low magnitude surface electromyogram. Comput Methods Programs Biomed. 2007 Jul;87(1):28-35. doi: 10.1016/j.cmpb.2007.04.004. Epub 2007 Jun 4.
PubMed 17548125
Love A, Leboeuf C, Crisp TC. Chiropractic chronic low back pain sufferers and self-report assessment methods. Part I. A reliability study of the Visual Analogue Scale, the Pain Drawing and the McGill Pain Questionnaire. J Manipulative Physiol Ther. 1989 Feb;12(1):21-5.
PubMed 2522493
Moutzouri M, Billis E, Strimpakos N, Kottika P, Oldham JA. The effects of the Mulligan Sustained Natural Apophyseal Glide (SNAG) mobilisation in the lumbar flexion range of asymptomatic subjects as measured by the Zebris CMS20 3-D motion analysis system. BMC Musculoskelet Disord. 2008 Oct 1;9:131. doi: 10.1186/1471-2474-9-131.
PubMed 18828921
Shrout PE, Fleiss JL. Intraclass correlations: uses in assessing rater reliability. Psychol Bull. 1979 Mar;86(2):420-8. doi: 10.1037//0033-2909.86.2.420.
PubMed 18839484
Henriksen M, Lund H, Moe-Nilssen R, Bliddal H, Danneskiod-Samsoe B. Test-retest reliability of trunk accelerometric gait analysis. Gait Posture. 2004 Jun;19(3):288-97. doi: 10.1016/S0966-6362(03)00069-9.
PubMed 15125918

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

All Chronic Low Back Pain trials

Study at a glance

From the registry record, last updated by the sponsor on 8 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Gait Analysis of Chronic Low Back Pain Patients Before and After the Application of Spinal Mobilization
ClinicalTrials.gov ID: NCT02645123
Acronym / sponsor ID: SpinMob / 721α/11-10-2011
Conditions: Chronic Low Back Pain
Keywords: spinal mobilization, manual therapy, gait analysis, low back pain, chronic
Study type: Interventional
Recruitment status: Completed
Enrolment: 75 participants (actual)
Lead sponsor: University of IoanninaUniversity, hospital or other
Study start: Dec 2011
Primary completion: Oct 2014 (actual)
Study completion: Nov 2014 (actual)
First posted: 1 Jan 2016 (estimated)
Results: Posted 8 Jun 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (participant)
Number of arms: 3

Arm	Type	Receives
Spinal mobilization	Experimental	Procedure: spinal mobilizationThe individuals of the group received 5 treatments in total for 10 minutes that included: posterior to anterior spinal accessory mobilization passive physiological inter vertebral rotation The above was applied to the level that the MRI showed disc degeneration
Sham Treatment	Sham comparator	Procedure: sham treatmentThe investigator touched the skin overlying the low back statically for 10 minutes
Classic Physiotherapy	Active comparator	Device: TENS, Procedure: swedish type massage, Procedure: static hamstring stretchThis group received static hamstring stretch for 5 minutes, TENS (2 channels biphasic pulse, 90Hz, 100μs pulse width) for 20 minutes and 15 minutes of Swedish type massage (effleurage, petrissage, kneading)

Who may qualify

Ages: 21 to 78 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

low back pain for over 3 months
recent lumbar MRI (up to 12 months)
able to walk without the need of walking aids

Key exclusion criteria (14 listed)

leg length discrepancy of over 2 cm
history of spinal surgery
history of autoimmune disease
history of spondylolysis and spondylolisthesis
spinal fractures

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
TENSEnraf-Nonius Sonopuls 692	Device	Classic Physiotherapy
spinal mobilizationpassive physiological intervertebral movements and passive accessory posteroanterior mobilization	Procedure or surgery	Spinal mobilization
swedish type massagepetrissage, effleurage, tapotement	Procedure or surgery	Classic Physiotherapy
static hamstring stretchstatic hamstring stretching	Procedure or surgery	Classic Physiotherapy
sham treatmenttouching of the skin overlying the lumbar area	Procedure or surgery	Sham Treatment

Primary outcome

Change in the Numerical Pain Rating Scale
Time frame: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient
this scale expresses the self rated pain levels in a 0 to 10 range with 0 meaning no pain and 10 the worst imaginable pain.
Change in the Oswestry Low Back Pain Disability Index
Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
this is a self rated questionnaire that is expressed in a percentage with 0% meaning no disability and 100% meaning total disability. The minimum detectable change is reported to be 10% points
Change in the Roland-Morris Disability Questionnaire
Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient
The Roland-Morris Disability Questionnaire is designed to assess self-rated physical disability caused by low back pain. The Roland-Morris Disability Questionnaire is most sensitive for patients with mild to moderate disability due to acute, sub-acute or chronic low back pain. For patients with severe disability the Oswestry disability questionnaire is recommended. in this case, we used the 24 question version in which 0 means no disability and 24 means total disability.
Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)
Time frame: before the beginning and after the end of 5 weeks for each patient
The data was recorded using relevant software (Cortex, Calcium Solver, Skeleton Builder, DV Reference, Sky Scripting, KinTools RT). Κinetic and kinematic data were assessed and analysed at 3 different gait cycle time moments defined by the gait cycle and the amount of ground reaction force (GRF) during both left and right foot contact: moment 1 (T1) was at maximum GRF during heel strike, moment 2 (T2) at minimum GRF during mid stance, and moment 3 (T3) at maximum GRF during acceleration before toe off (http://www.oandplibrary.org/popup.asp?frmItemId=2A1E740F-13FD-4A68-B8A3-83A407795B5F\&frmType=image\&frmId=1). From these, we extrapolated the quotient (between R and L kinetic and kinematic data) values. A value of 1 would mean absolute symmetry between left and right side (Seliktar and Mizrahi, 1986). the participants walked for 10 times and the mean values of the best 3 measurements were used for analysis.

Results and safety

Results posted to the registry on 8 Jun 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Spinal Mobilization	25	25
Sham Treatment	25	25
Classic Physiotherapy	25	25

Primary outcome: Change in the Numerical Pain Rating Scale

Time frame: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient. Mean (Standard Deviation). Unit: units on a scale

Measure	Spinal Mobilization n = 25	Sham Treatment n = 25	Classic Physiotherapy n = 25
Baseline values	5.96 (1.37)	6.12 (1.05)	6 (1)
5 sessions after	1.22 (1.1)	5.88 (0.92)	4.96 (0.89)
6 months after	1.32 (0.75)	6.02 (0.93)	5.08 (0.95)

Primary outcome: Change in the Oswestry Low Back Pain Disability Index

Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient. Mean (Standard Deviation). Unit: units on a scale

Measure	Spinal Mobilization n = 25	Sham Treatment n = 25	Classic Physiotherapy n = 25
Baseline values	33.28 (15.02)	32 (8.32)	31.04 (11.07)
5 sessions after	9.84 (3.87)	31.76 (8.51)	27.28 (9.53)
6 months after	8.96 (3.75)	32.8 (8.64)	28.56 (9.62)

Primary outcome: Change in the Roland-Morris Disability Questionnaire

Time frame: before the beginning, after the end of 5 weeks for each patient and 6 months after the last treatment session for each patient. Mean (Standard Deviation). Unit: units on a scale

Measure	Spinal Mobilization n = 25	Sham Treatment n = 25	Classic Physiotherapy n = 25
Baseline values	8.56 (3.56)	10 (1.96)	9.96 (3.19)
5 sessions after	2.44 (1.76)	10.04 (2.05)	8.76 (2.96)
6 months after	2.48 (1.29)	10.23 (1.89)	8.68 (2.87)

Primary outcome: Change in the 3 Dimensional Gait Characteristics (Kinetic and Kinematic) (Motion Analysis Optoelectronic Gait Analysis System Along With 2 Kistler Force Platforms)

Time frame: before the beginning and after the end of 5 weeks for each patient. Mean (Standard Deviation). Unit: quotient: degrees/degrees=no unit

Measure	Spinal Mobilization n = 25	Sham Treatment n = 25	Classic Physiotherapy n = 25
torso position frontal plane quotient at T1	-1.147 (0.035)	0.852 (0.25)	-0.4 (0.18)
torso position frontal plane quotient at T2	-1.307 (0.127)	0.172 (0.025)	-0.429 (0.33)
pelvis position frontal plane quotient at T2	0.844 (0.102)	1.295 (0.355)	1.044 (0.422)
torso position coronal plane quotient at T2	0.272 (0.058)	1.645 (0.454)	-1.819 (0.485)
pelvis position frontal plane quotient at T3	-1.236 (0.232)	-0.16 (0.128)	-0.679 (0.254)

Population analysed: all participants were chronic low back pain patients with a variable degree of vertebral disc degeneration defined by the modified Pfirrmann scale

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Spinal Mobilization	0 of 25 (0%)	0 of 25 (0%)	Not reported
Sham Treatment	0 of 25 (0%)	0 of 25 (0%)	Not reported
Classic Physiotherapy	0 of 25 (0%)	0 of 25 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 10863253Goodsell M, Lee M, Latimer J. Short-term effects of lumbar posteroanterior mobilization in individuals with low-back pain. J Manipulative Physiol Ther. 2000 Jun;23(5):332-42.
Background: PubMed 24960844Managing chronic low back pain. How to avoid the problem, lower risk, and manage the discomfort when it occurs. Duke Med Health News. 2014 May;20(5):1-2. No abstract available.
Background: PubMed 9413588Goel A, Loudon J, Nazare A, Rondinelli R, Hassanein K. Joint moments in minor limb length discrepancy: a pilot study. Am J Orthop (Belle Mead NJ). 1997 Dec;26(12):852-6.
Background: PubMed 9531400Liu XC, Fabry G, Molenaers G, Lammens J, Moens P. Kinematic and kinetic asymmetry in patients with leg-length discrepancy. J Pediatr Orthop. 1998 Mar-Apr;18(2):187-9.
Background: PubMed 1913023McCaw ST, Bates BT. Biomechanical implications of mild leg length inequality. Br J Sports Med. 1991 Mar;25(1):10-3. doi: 10.1136/bjsm.25.1.10.
Background: PubMed 7855687Kawaguchi Y, Matsui H, Tsuji H. Back muscle injury after posterior lumbar spine surgery. Part 2: Histologic and histochemical analyses in humans. Spine (Phila Pa 1976). 1994 Nov 15;19(22):2598-602. doi: 10.1097/00007632-199411001-00018.
Background: PubMed 12486343Taylor H, McGregor AH, Medhi-Zadeh S, Richards S, Kahn N, Zadeh JA, Hughes SP. The impact of self-retaining retractors on the paraspinal muscles during posterior spinal surgery. Spine (Phila Pa 1976). 2002 Dec 15;27(24):2758-62. doi: 10.1097/00007632-200212150-00004.
Background: PubMed 14569260Wang D, Bergstrom E, Clarke M, Henderson N, Gardner B. Mobility of the spine after spinal surgery in acute spinal cord injury. Spinal Cord. 2003 Nov;41(11):593-9. doi: 10.1038/sj.sc.3101528.
Background: PubMed 9431633O'Sullivan PB, Phyty GD, Twomey LT, Allison GT. Evaluation of specific stabilizing exercise in the treatment of chronic low back pain with radiologic diagnosis of spondylolysis or spondylolisthesis. Spine (Phila Pa 1976). 1997 Dec 15;22(24):2959-67. doi: 10.1097/00007632-199712150-00020.
Background: PubMed 21550245Egerton T, Danoudis M, Huxham F, Iansek R. Central gait control mechanisms and the stride length - cadence relationship. Gait Posture. 2011 Jun;34(2):178-82. doi: 10.1016/j.gaitpost.2011.04.006. Epub 2011 May 7.
Background: PubMed 17548125Mello RG, Oliveira LF, Nadal J. Digital Butterworth filter for subtracting noise from low magnitude surface electromyogram. Comput Methods Programs Biomed. 2007 Jul;87(1):28-35. doi: 10.1016/j.cmpb.2007.04.004. Epub 2007 Jun 4.
Background: PubMed 2522493Love A, Leboeuf C, Crisp TC. Chiropractic chronic low back pain sufferers and self-report assessment methods. Part I. A reliability study of the Visual Analogue Scale, the Pain Drawing and the McGill Pain Questionnaire. J Manipulative Physiol Ther. 1989 Feb;12(1):21-5.
Individual participant dataSharing planned: Yes. individual participant's grade of disc degeneration has been shared as an appendix in an already published article: http://dx.doi.org/10.1080/10669817.2016.1184435. Please note that no more IPD will be shared.

Related trials for Chronic Low Back Pain

Not yet recruiting
Effect of Lumbar Stabilization Exercises With and Without YTWL (Scapular Stabilization Exercises) on Reducing Chronic Low Back Pain and Related Disability. A Randomized Clinical Trial,
Chronic Non Specific Mechanical Low Back Pain
Not yet recruiting
Comparing Non-Medicine Strategies for Improving Low Back Pain
Chronic Low-back Pain (cLBP), High-Impact Chronic Pain (HICP)
Not yet recruiting
Spinery Basivertebral Nerve Ablation for Vertebrogenic Chronic Low Back Pain
Low Back Pain, Chronic Low Back Pain (CLBP)
Enrolling by invitation
Effects of 3-dimensional Versus Dynamic Myofascial Release Techniques With Lumbar Mobilization and Exercise Therapy Program in Chronic Non-specific Low Back Pain.
Chronic Non-Specific Low Back Pain, Myofascial Release
RecruitingPhase 2
A Master Protocol Study (LY900028) of Multiple Intervention-Specific-Appendices (ISAs) in Participants With Chronic Pain
Osteoarthritis, Knee, Diabetic Neuropathic Pain

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.

GEORGIOS O KREKOUKIAS, PT, MSc, PhD principal investigator

University of Ioannina

IOANNIS D GELALIS, MD, PhD study director

University of Ioannina

Questions about this trial

What is this clinical trial studying?

A study testing TENS, spinal mobilization and swedish type massage in people with Chronic Low Back Pain, run by University of Ioannina.

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 3 inclusion and 14 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 8 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Change in the Numerical Pain Rating Scale (time frame: before the beginning, after the end of 5 weeks and 6 months after the last treatment session for each patient). The study lists 4 primary outcomes in all. 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 NCT02645123, which also lists 23 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 8 Jun 2017.