ExerciseNCT03527524
Effect of Exercises on Pain, Functional Disability and Lumbar Stability in Patients With Low Back Pain
A study testing exercise with ball and exercise without ball in people with Exercise, run by Mahidol University.
Trial summary
The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain. Read more about this study
- Who is it for?
- Ages 20 to 68 years
- Conditions the study is for
- Exercise
- What is being tested?
- exercise with ball and exercise without ball
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- Feb 2015to Jun 2015
- 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 20 to 68 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female with low back pain (LBP) > 3 months
- Body mass index (BMI) = 18-25 kg/m2
- Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)
- Willing and able to perform exercise programs
- No cognitive impairment
- Age at least 19 years
Who cannot join
- Having experiences in the core stabilization exercise and Swiss ball exercises
- Past history of back and abdomen surgery
- Recent fractures of spine, hip or lower limb
- Current use of steroids or any other drugs for resolving back pain
- Red flags (fractures, cancer, infection, cauda equine syndrome)
- Pregnancy
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- Neuromuscular or respiratory disorders
- Rheumatologic disorders
- Hip and knee stiffness
- Pain intensity > 60 of 100 mm assessed by the VAS
About this study
Official title: Effects of Core Stabilization Exercises With and Without Ball on Pain, Functional Disability and Level of Lumbar Stability in Patients With Non-specific Chronic Low Back Pain
The purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.
Read the detailed description
For Patient Registries:
The participant was screened for inclusion criteria and was asked to sign the informed consent prior to participate. A randomized control trial was performed with participants randomly divided into one of the two treatment groups: core stabilization exercise with ball and core stabilization exercise without ball by using sealed envelopes.
- Conditions
- Exercise
- Being tested
- exercise with ball, exercise without ball
- Keywords
- exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise with ballOther
exercise with ball
exercise without ballOther
exercise without ball
| Study group | Role | What they receive |
|---|---|---|
| exercise with ball | Experimental | The participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes. Receives: Other: exercise with ball |
| exercise without ball | Other | The participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes. Receives: Other: exercise without ball |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain scale
a 0-100 mm of horizontal line (Visual analog scale) assessing pain intensity - reported the distance measured in millimeters from the left hand side of this line to the point that participant marked
Measured: 4 weeks
Secondary outcomes (2)
Questionnaire scores of functional disability measure
Thai modified Oswestry Disability Low Back Pain Disability Questionnaire
Measured: 4 weeks
Levels of lumbar stability
isometric abdominal contraction assessing lumbar stability
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 May 2018
- Study startFeb 2015
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by Mahidol 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Apinkarn Jaroenlarp, MSc, Principal investigator, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03527524
- Sponsor's protocol ID
- MahidolU_Wunpen1
- Status last verified
- May 2018
- First submitted
- 5 Jan 2017
- Last updated
- 17 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Core Stabilization Exercises With and Without Ball on Pain, Functional Disability and Level of Lumbar Stability in Patients With Non-specific Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT03527524
- Acronym / sponsor ID
- MahidolU_Wunpen1
- Conditions
- Exercise
- Keywords
- exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- Feb 2015
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 17 May 2018 (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 purposes of this study are to compare the effects of core stabilization exercises on pain intensity, functional disability and lumbar stability between using and not using the Swiss ball in patients with non-specific chronic low back pain.
Detailed description
For Patient Registries:
The participant was screened for inclusion criteria and was asked to sign the informed consent prior to participate. A randomized control trial was performed with participants randomly divided into one of the two treatment groups: core stabilization exercise with ball and core stabilization exercise without ball by using sealed envelopes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| exercise with ball | Experimental | Other: exercise with ballThe participant in core stabilization exercise with ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes. |
| exercise without ball | Other | Other: exercise without ballThe participant in core stabilization exercise without ball group performed 12 training sessions of the core stabilization exercises, 3 days/week for 4 weeks. Each exercise took 15 times/set and each participant did it repeatedly for 3 sets and rested 1 minute between sets. The total time of core stabilization exercise was 20 minutes and assessment time was 10 minutes. |
Who may qualify
- Ages
- 20 to 68 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male and female with low back pain (LBP) > 3 months
- Body mass index (BMI) = 18-25 kg/m2
- Non-specific LBP (pain at the lower lumbar between costal margin but not below gluteal fold)
- Willing and able to perform exercise programs
- No cognitive impairment
Key exclusion criteria (10 listed)
- Having experiences in the core stabilization exercise and Swiss ball exercises
- Past history of back and abdomen surgery
- Recent fractures of spine, hip or lower limb
- Current use of steroids or any other drugs for resolving back pain
- Red flags (fractures, cancer, infection, cauda equine syndrome)
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 |
|---|---|---|
| exercise with ballexercise with ball | Other | exercise with ball |
| exercise without ballexercise without ball | Other | exercise without ball |
Primary outcome
Pain scale
Time frame: 4 weeks
a 0-100 mm of horizontal line (Visual analog scale) assessing pain intensity - reported the distance measured in millimeters from the left hand side of this line to the point that participant marked
2 secondary outcomes
Questionnaire scores of functional disability measure
Time frame: 4 weeks
Levels of lumbar stability
Time frame: 4 weeks
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 17 May 2018.
- Individual participant dataSharing planned: No
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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.
Apinkarn Jaroenlarp, MSc principal investigator
Mahidol University
Questions about this trial
What is this clinical trial studying?
A study testing exercise with ball and exercise without ball in people with Exercise, run by Mahidol University.
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 10 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 17 May 2018. 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. 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 scale (time frame: 4 weeks). 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 17 May 2018.