Low Back Pain+DWRNCT00888524
Plus Deep Water Running on Low Back Pain
A study testing GP in Physio and GP in Physio plus DWR in people with Low Back Pain, run by University of Malaga at 1 site in Spain.
Trial summary
Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- GP in Physio and GP in Physio plus DWR
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2006to Sep 2007
- 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
- Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months
Who cannot join
- Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
- Patients not able to follow instructions
- Patients with any digressive condition
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.
Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.
- Conditions
- Low Back Pain
- Being tested
- GP in Physio, GP in Physio plus DWR
- Keywords
- head out water immersion,, high intensity exercise,, evidence-based physiotherapy;, aquatics;, hydrotherapy, aquatics therapy, exercise therapy
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GP in PhysioProcedure or surgery
manual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment
GP in Physio plus DWRProcedure or surgery
GP in Physio plus a supplementation of DWR training in high intensive aerobic threshold
| Study group | Role | What they receive |
|---|---|---|
| General Practice (GP) in Physio plus Deep water running | Experimental | A supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test Receives: Procedure: GP in Physio plus DWR |
| General Practice in Physio | Experimental | A procedure of evidence-based physiotherapy is usual care in pragmatic trial Receives: Procedure: GP in Physio |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain in VAS
Measured: scale 0 -100, pre and post intervention and follow up 6 and 12 month
Secondary outcomes (3)
disability RMQ
Measured: scale 0-24, pre and post intervention and follow up 6 and 12 month
general (mental and physical) health state with SF-12
Measured: scale 0 -100, pre and post intervention and follow up 6 and 12 month
functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)
Measured: scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2009 (estimated)
- Study startJan 2006
- Primary completionSep 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Malaga
- Sponsor type
- University, hospital or other
- Investigators
- Antonio Cuesta-Vargas, PhD, Principal investigator, University of Malaga
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00888524
- Sponsor's protocol ID
- 857 IAC 0630041300
- Other IDs
- 857 IAC 0630041300
- Acronym
- +DWR
- Status last verified
- Apr 2009
- First submitted
- 22 Apr 2009
- Last updated
- 27 Apr 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evidence-Based Physiotherapy With and Without Deep Water Running on Non-Specific Low Back Pain. A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00888524
- Acronym / sponsor ID
- +DWR / 857 IAC 0630041300
- Conditions
- Low Back Pain
- Keywords
- head out water immersion,, high intensity exercise,, evidence-based physiotherapy;, aquatics;, hydrotherapy, aquatics therapy, exercise therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- University of MalagaUniversity, hospital or other
- Study start
- Jan 2006
- Primary completion
- Sep 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 27 Apr 2009 (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.
Objectives: To evaluate the effect size on non-specific chronic low back pain (CLBP) of evidence-based physiotherapy (EBP) with and without the addition of deep water running (DWR) on pain, physical disability and general health state.
Materials and methods: Randomized, double-blind, controlled trial (therapists and assessors) involving 46 persons with CLBP over 15 weeks with two interventions, presented three times a week. Each group received EBP (personalized exercise program, manual therapy and health education) while one group performed supplementary 20 min sessions of DWR at the individualized aerobic threshold. Measurements were made pre and post intervention for pain, disability and general health. Range of motion of lumbar spine in the sagittal plane, maximum isometric strength and muscle endurance of lumbar and hip extensors was assessment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Practice (GP) in Physio plus Deep water running | Experimental | Procedure: GP in Physio plus DWRA supplementation of Deep Water running exercises of 20 minutes in high intensity around aerobic thresholds estimated in individual land and water test |
| General Practice in Physio | Experimental | Procedure: GP in PhysioA procedure of evidence-based physiotherapy is usual care in pragmatic trial |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants were diagnosed with non-specific CLBP, with no radiation to the legs, and lasting at least three months
Key exclusion criteria (3 listed)
- Low back pain as a result of specific spinal disease, infection, tumor, osteoporosis, fracture, structural deformity, inflammatory disorder, radicular syndrome or caudal equine syndrome
- Patients not able to follow instructions
- Patients with any digressive condition
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 |
|---|---|---|
| GP in Physiomanual therapy, educational advice of health promotion and physical exercises therapy based in a individual assessment | Procedure or surgery | General Practice in Physio |
| GP in Physio plus DWRGP in Physio plus a supplementation of DWR training in high intensive aerobic threshold | Procedure or surgery | General Practice (GP) in Physio plus Deep water running |
Primary outcome
pain in VAS
Time frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
3 secondary outcomes
disability RMQ
Time frame: scale 0-24, pre and post intervention and follow up 6 and 12 month
general (mental and physical) health state with SF-12
Time frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month
functional Measurements: range on motion in degrees with inclinometer dual, strength with lineal dynamometer (newton) and endurance muscular with soerensen test (seconds)
Time frame: scale physica of degrees, newtons and seconds pre post intervention and 6 and 12 month of follow up
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 27 Apr 2009.
- University of MalagaLink provided by the sponsor.
- Research And Development of SpainLink provided by the sponsor.
- Food and Drugs AdministrationLink provided by the sponsor.
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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.
Antonio Cuesta-Vargas, PhD principal investigator
University of Malaga
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GP in Physio and GP in Physio plus DWR in people with Low Back Pain, run by University of Malaga at 1 site in Spain.
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 3 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 27 Apr 2009. 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 Spain. 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?
pain in VAS (time frame: scale 0 -100, pre and post intervention and follow up 6 and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Apr 2009.