Chronic Nonspecific Low Back PainPhase 2/3NCT01911806
Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
A Phase 2/3 study testing Back care pillow and standard physical therapy treatment in people with Chronic Nonspecific Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
Trial summary
This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain. Read more about this study
- Who is it for?
- Ages 20 to 69 years
- Conditions the study is for
- Chronic Nonspecific Low Back Pain
- What is being tested?
- Back care pillow and standard physical therapy treatment
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteThailand
- Study dates
- Mar 2013to Dec 2013
- Phase
- Phase 2/3
- 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 20 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females
- Age 20 - 69 years old.
- Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day
- Patients with low back pain who have pain for more than 3 months
- Patients have pain at lower back without refer to leg
- Patients have moderate to severe pain of numerical rating scale (pain score ≥ 4)
Who cannot join
- Pregnant patients
- Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery
- Patients have Quada equine syndrome
- Patients with nerve root symptoms (neurological deficit)
- Patient have refer pain to leg area of same dermatome is problem.
- Abnormal reflex of lower extremity.
- Muscle weakness of area myotome is problem.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
School of physical therapy,Faculty of associated medical science,Khon Kaen University
Khon Kaen, Changwat Khon Kaen, 40002
About this study
This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.
- Conditions
- Chronic Nonspecific Low Back Pain
- Being tested
- Back care pillow, standard physical therapy treatment
- Keywords
- Back care pillow, chronic non-specific low back pain, randomized controlled trial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Back care pillowDevice
back care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees
standard physical therapy treatmentProcedure or surgery
standard physical therapy treatment are ultrasound therapy and hot pack
| Study group | Role | What they receive |
|---|---|---|
| Back care pillow & standard physical therapy treatment | Experimental | standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks \& back care pillow use during the day for 2 weeks Receives: Device: Back care pillow; Procedure: standard physical therapy treatment |
| standard physical therapy treatment | Active comparator | standard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks Receives: Procedure: standard physical therapy treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores on the Numerical rating scale
Measured: three months
Secondary outcomes (1)
Scale of lumbar range of motion measure by Modified - Modified Schober Test
Measured: three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2013 (estimated)
- Study startMar 2013
- Primary completionJul 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Nonspecific 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bundit Prommanon, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01911806
- Sponsor's protocol ID
- MRG555S021
- Status last verified
- Aug 2014
- First submitted
- 30 Mar 2013
- Last updated
- 26 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Back Care Pillow in Addition to Physical Therapy in Chronic Non-specific Low Back Pain Treatment
- ClinicalTrials.gov ID
- NCT01911806
- Acronym / sponsor ID
- MRG555S021
- Conditions
- Chronic Nonspecific Low Back Pain
- Keywords
- Back care pillow, chronic non-specific low back pain, randomized controlled trial
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 30 Jul 2013 (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.
This study aim to investigate the effects of back care pillow, in adjective with standard physical therapy treatment for chronic non-specific low back pain.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Back care pillow & standard physical therapy treatment | Experimental | Device: Back care pillow, Procedure: standard physical therapy treatmentstandard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks \& back care pillow use during the day for 2 weeks |
| standard physical therapy treatment | Active comparator | Procedure: standard physical therapy treatmentstandard physical therapy treatment for 6 sessions of treatment, each around 30 minutes, during a period of 2 weeks |
Who may qualify
- Ages
- 20 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males or females
- Age 20 - 69 years old.
- Patients who have daily routine in so long bending of sitting or standing position at least 2 hours per day
- Patients with low back pain who have pain for more than 3 months
- Patients have pain at lower back without refer to leg
Key exclusion criteria (7 listed)
- Pregnant patients
- Underlying systematic or visceral disease, and specific condition such as neoplasm, ankylosing spondylitis, previous low back surgery
- Patients have Quada equine syndrome
- Patients with nerve root symptoms (neurological deficit)
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 |
|---|---|---|
| Back care pillowback care pillow is specific size by age groups of standard deviation of the lumbar spinal curvature, in 20-29 years was 51.68 ± 6.94 degrees, in 30-39 years was 59.67 ± 7.02 degrees, in 40-49 years was 63.66 ± 7.62 degrees, in 50-59 years was 65.75 ± 10.85 degrees and in 60-69 years was 64.19 ± 9.69 degrees | Device | Back care pillow & standard physical therapy treatment |
| standard physical therapy treatmentstandard physical therapy treatment are ultrasound therapy and hot pack | Procedure or surgery | Back care pillow & standard physical therapy treatment, standard physical therapy treatment |
Primary outcome
Pain Scores on the Numerical rating scale
Time frame: three months
1 secondary outcome
Scale of lumbar range of motion measure by Modified - Modified Schober Test
Time frame: three months
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 26 Aug 2014.
Related trials for Chronic Nonspecific Low Back Pain
Not yet recruiting
Dual-Task Core Stabilization Training in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low Back Pain
Recruiting
A Novel Treatment for Chronic Low Back Pain Using Multi Angular Isometric Lumbar Exercise: Randomized Clinical Trial.
Nonspecific Low Back Pain, Low Back Pain
Recruiting
Effects of Virtual Reality Exergames Versus Spinal Manipulation in Chronic Nonspecific Low Back Pain
Chronic Nonspecific Low-back Pain, CNSLBP
Not yet recruiting
Gamified Home-Based Core Neuromuscular Training for Chronic Low Back Pain
Low Back Pain, Core Muscles
Not yet recruiting
Visual Feedback-Assisted Sensorimotor Training in Chronic Nonspecific Low Back Pain
Chronic Low Back 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Back care pillow and standard physical therapy treatment in people with Chronic Nonspecific Low Back Pain, run by Khon Kaen University at 1 site in Thailand.
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 6 inclusion and 7 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 26 Aug 2014. 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 Thailand. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Scores on the Numerical rating scale (time frame: three months). 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 26 Aug 2014.