Back Pain Lower Back ChronicNCT01496144
Manual Therapy on the Improvement of Functional Disability in Patients With Chronic Non Specific Low Back Pain
A study testing Manual therapy and active exercises and Detuned ultrasound and active exercises in people with Back Pain Lower Back Chronic, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
Trial summary
Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Back Pain Lower Back Chronic
- What is being tested?
- Manual therapy and active exercises and Detuned ultrasound and active exercises
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2005to Jan 2011
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
- can maintain the usual medication
Who cannot join
- spinal fracture or surgery within the previous 6 months
- pregnancy
- neoplasia
- spinal infection
- spinal inflammatory arthritis
- low back pain of visceral origin
Show all 14Show fewer
- severe sensitive and/or motor radicular deficit from nerve root origin of less than 6 months
- score of 3/5 or more on the Waddell Score
- on sick leaves from work for 6 months or more
- psychiatric disorders
- opioid medication
- patient unable to collaborate (linguistic barrier; cognitive impairments)
- radiologic abnormalities other than degenerative disease
- clinical neurogenic claudication.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Département de l'appareil locomoteur (DAL), Centre Hospitalier Universitaire Vaudois (CHUV)
Lausanne, Canton of Vaud, 1005
About this study
Official title: 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
Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.
- Conditions
- Back Pain Lower Back Chronic
- Being tested
- Manual therapy and active exercises, Detuned ultrasound and active exercises
- Keywords
- Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manual therapy and active exercisesProcedure or surgery
Also called Spinal mobilisation, Manipulation
Spinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust.
Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises
Detuned ultrasound and active exercisesProcedure or surgery
Also called Electrotherapy
Electrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises
| Study group | Role | What they receive |
|---|---|---|
| Manual therapy and active exercises | Experimental | Spinal manipulation /mobilisation Receives: Procedure: Manual therapy and active exercises |
| Detuned ultrasound and active exercises | Placebo comparator | Not described Receives: Procedure: Detuned ultrasound and active exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale - VAS-pain
self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements "no pain" on the left and "maximum intensity of pain" on the right
Measured: During treatment, over a period of 4 to 8 weeks
Secondary outcomes (1)
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)
measures level of fear and avoidance beliefs about work and physical activity in patients with low back pain
Measured: Before randomization and untill 6 months after the end of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2011 (estimated)
- Study startDec 2005
- Primary completionDec 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Back Pain Lower Back ChronicStudies 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Applied Sciences of Western Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Responsible party
- Principal investigator, Pierre Balthazard, University of Applied Sciences of Western Switzerland
- Investigators
- Olivier Dériaz, MD, PhD, Study director, Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01496144
- Sponsor's protocol ID
- FNS13DPD3-109903
- Other IDs
- FNS13DPD3-109903
- Status last verified
- Dec 2011
- First submitted
- 16 Dec 2011
- Last updated
- 21 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.
PubMed 17250965Aure 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 12642755Hemmila HM, Keinanen-Kiukaanniemi SM, Levoska S, Puska P. Long-term effectiveness of bone-setting, light exercise therapy, and physiotherapy for prolonged back pain: a randomized controlled trial. J Manipulative Physiol Ther. 2002 Feb;25(2):99-104. doi: 10.1067/mmt.2002.122329.
PubMed 11896377Niemisto L, Lahtinen-Suopanki T, Rissanen P, Lindgren KA, Sarna S, Hurri H. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2185-91. doi: 10.1097/01.BRS.0000085096.62603.61.
PubMed 14520029Assendelft 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 12779297Balthazard 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.
PubMed 22925609
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01496144
- Acronym / sponsor ID
- FNS13DPD3-109903
- Conditions
- Back Pain Lower Back Chronic
- Keywords
- Chronic non specific low back pain, Manual therapy, Active exercises, Pain, Disability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Applied Sciences of Western SwitzerlandUniversity, hospital or other
- Collaborators
- Centre Hospitalier Universitaire Vaudois
- Study start
- Dec 2005
- Primary completion
- Dec 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 21 Dec 2011 (estimated)
- 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.
Background: Models have tried to explain the driving mechanisms behind chronic non specific low back pain (CNSLBP) in order to propose better appropriate conservative treatment. Altered responses at spinal and/or supraspinal level may affect the perception of pain and degree of disability of CNSLBP patients. Recent clinical recommendations still propose active exercises (AE) for CNSLBP. However, acceptance of exercises by patients may be limited by pain-related manifestations. Current evidences suggest manual therapy (MT) induces a short-term analgesic effect through neurophysiological mechanisms at peripheral, spinal and cortical levels. The aim of this study was first, to assess whether MT has an instant analgesic effect, and second, to compare the long-lasting effect on functional disability of MT followed by AE to sham therapy (ST) followed by AE. Methods: Forty-two CNSLBP patients without co-morbidities, randomly distributed into 2 treatment groups, received either spinal manipulation/mobilization (first intervention) plus AE (MT group; n = 22), or detuned ultrasound (first intervention) plus AE (ST group; n = 20). Eight therapeutic sessions were delivered over 4 to 8 weeks. Instant analgesic effect was obtained by measuring pain intensity (Visual Analogue Scale) before and immediately after the first intervention of each therapeutic session. Pain intensity, disability (Oswestry Disability Index) and fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire) were determined before treatment, after the 8th therapeutic session, and at 3- and 6-month follow-ups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manual therapy and active exercises | Experimental | Procedure: Manual therapy and active exercisesSpinal manipulation /mobilisation |
| Detuned ultrasound and active exercises | Placebo comparator | Procedure: Detuned ultrasound and active exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- suffering from non specific low back pain with or without symptoms in the lower extremity for a period between 12 and 26 weeks
- can maintain the usual medication
Key exclusion criteria (14 listed)
- spinal fracture or surgery within the previous 6 months
- pregnancy
- neoplasia
- spinal infection
- spinal inflammatory arthritis
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 |
|---|---|---|
| Manual therapy and active exercisesAlso: Spinal mobilisation, ManipulationSpinal manipulation/mobilisation (5-10 minutes), consisting of passive accessory intervertebral movements, muscle-energy techniques and high velocity, low amplitude dynamic thrust. Active exercises (20 minutes), consisting of mobility, stretching, strengthening and motor control exercises | Procedure or surgery | Manual therapy and active exercises |
| Detuned ultrasound and active exercisesAlso: ElectrotherapyElectrotherapy device inactivated and ineffective. Active exercises, consisting of mobility, stretching, strengthening and motor control exercises | Procedure or surgery | Detuned ultrasound and active exercises |
Primary outcome
Visual Analogue Scale - VAS-pain
Time frame: During treatment, over a period of 4 to 8 weeks
self-report of clinical pain intensity, consisting of a 10 cm horizontal line scale on which is added the statements "no pain" on the left and "maximum intensity of pain" on the right
1 secondary outcome
Fear-avoidance beliefs (Fear-Avoidance Beliefs Questionnaire - FABQ)
Time frame: Before randomization and untill 6 months after the end of treatment
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 21 Dec 2011.
- Background: PubMed 17250965Ferreira ML, Ferreira PH, Latimer J, Herbert RD, Hodges PW, Jennings MD, Maher CG, Refshauge KM. Comparison of general exercise, motor control exercise and spinal manipulative therapy for chronic low back pain: A randomized trial. Pain. 2007 Sep;131(1-2):31-7. doi: 10.1016/j.pain.2006.12.008. Epub 2007 Jan 23.
- 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 11896377Hemmila HM, Keinanen-Kiukaanniemi SM, Levoska S, Puska P. Long-term effectiveness of bone-setting, light exercise therapy, and physiotherapy for prolonged back pain: a randomized controlled trial. J Manipulative Physiol Ther. 2002 Feb;25(2):99-104. doi: 10.1067/mmt.2002.122329.
- Background: PubMed 14520029Niemisto L, Lahtinen-Suopanki T, Rissanen P, Lindgren KA, Sarna S, Hurri H. A randomized trial of combined manipulation, stabilizing exercises, and physician consultation compared to physician consultation alone for chronic low back pain. Spine (Phila Pa 1976). 2003 Oct 1;28(19):2185-91. doi: 10.1097/01.BRS.0000085096.62603.61.
- 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.
- Derived from this study: PubMed 22925609Balthazard 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.
Related trials for Back Pain Lower Back Chronic
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.
Olivier Dériaz, MD, PhD study director
Institut de Recherche en Réadaptation et Clinique Romande de Réadaptation SUVACare, Sion, Switzerland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Manual therapy and active exercises and Detuned ultrasound and active exercises in people with Back Pain Lower Back Chronic, run by University of Applied Sciences of Western Switzerland at 1 site in Switzerland.
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 2 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 21 Dec 2011. 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 Switzerland. 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. 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?
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?
Visual Analogue Scale - VAS-pain (time frame: During treatment, over a period of 4 to 8 weeks). 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 NCT01496144, which also lists 6 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 21 Dec 2011.