Chronic Low Back PainEarly Phase 1CLBNCT02222935
Effectiveness of Balance Training in Chronic Low Back Pain Patients
A Early Phase 1 study testing Balance Exercise Training and Routine Back exercise program in people with Chronic Low Back Pain, run by Baskaran Chandrasekaran at 1 site in India.
Trial summary
Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. Read more about this study
- Who is it for?
- Ages 25 to 45 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- Balance Exercise Training and Routine Back exercise program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteIndia
- Study dates
- Jun 2014to Dec 2014
- Phase
- Early Phase 1
- 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 25 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- non specific low back pain diagnosed by orthopedical surgeon or physiatrist
- Both genders
- Age 25 - 45 years (to avoid age related balance deficit)
- Should have balance deficit percentage (> 20%) through balance assessment scale
Who cannot join
- H/O Benign Paroxysmal Positional Vertigo
- Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance
- any form of ear infection
- Recent ear, nose, throat surgery
- Recent surgery in abdomen, thorax, head (< 2 years)
- Recent lower limb surgeries, injuries (< 6 months)
- Any form of walking aids (cane, walker)
Trial locations and contacts
1 site in 1 country.
India1 site
PSG Hospitals, Department of Physical Medicine Rehabilitation
Coimbatore, Tamil Nadu, 641004
About this study
Official title: Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients
Read the detailed description
Background: Balance deficits are common in low back pain. Current literature fail to prove the effectiveness of routine back exercises in improving balance of back pain patients. No study has concentrated on balance training in back pain patients.
Objective: Compare balance exercises and routine back exercises in improving balance and other functional outcomes.
Procedure: Back pain patients attending physiotherapy department of tertiary care teaching hospitals will be recruited voluntarily. Randomised to either balance and routine program based on simple lottery method. Balance training comprises of 5 exercises - single leg squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and post 2 weeks outcome scores will be analysed through paired and unpaired for between and within groups.
- Conditions
- Chronic Low Back Pain
- Being tested
- Balance Exercise Training, Routine Back exercise program
- Keywords
- Balance training, low back pain, balance test, routine back exercise
- 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.
Balance Exercise TrainingBehavioural
Balance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks
Routine Back exercise programBehavioural
Back strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Balance exercise training | Experimental | Balance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets Receives: Behavioral: Balance Exercise Training |
| Routine Back exercise Program | Active comparator | Routine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks Receives: Behavioral: Routine Back exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Starr Edward Balance Test
Measured: Baseline, 2 weeks
Secondary outcomes (2)
Berg Balance Scale
Measured: Baseline, 2 weeks
Visual Analogue score
Measured: Baseline, 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskaran Chandrasekaran
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Baskaran Chandrasekaran, PSG Hospitals
- Investigators
- Pavita Devi, BPT, Principal investigator, Senior PhysiotherapistBaskaran Chandrasekaran, MPT, Study chair, Senior PhysiotherapistSumathi Muraleetharan, BPT, Study chair, Senior PhysiotherpistRamamoorthy V Dr, MD PMR, Study director, Head of The Department, PMR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02222935
- Sponsor's protocol ID
- PSG02
- Acronym
- CLB
- Status last verified
- Aug 2014
- First submitted
- 20 Aug 2014
- Last updated
- 22 Aug 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Balance Training Over Routine Back Exercise in Improving Functional Outcomes of Chronic Low Back Pain Patients
- ClinicalTrials.gov ID
- NCT02222935
- Acronym / sponsor ID
- CLB / PSG02
- Conditions
- Chronic Low Back Pain
- Keywords
- Balance training, low back pain, balance test, routine back exercise
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Baskaran ChandrasekaranUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 22 Aug 2014 (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.
Balance problems are addressed in low back pain patients. Dearth of literature available to prove core strengthening or any form of back exercises improving functional outcomes or balance in chronic back pain patients. No studies focus on balance training in improving balance of low back pain patients. The authors are conducting a randomised trial comparing balance exercises and routine back exercise program in improving pain, functional outcomes and balance of the patients
Detailed description
Background: Balance deficits are common in low back pain. Current literature fail to prove the effectiveness of routine back exercises in improving balance of back pain patients. No study has concentrated on balance training in back pain patients.
Objective: Compare balance exercises and routine back exercises in improving balance and other functional outcomes.
Procedure: Back pain patients attending physiotherapy department of tertiary care teaching hospitals will be recruited voluntarily. Randomised to either balance and routine program based on simple lottery method. Balance training comprises of 5 exercises - single leg squats, dead lift, single leg raises, lateral step-ups and forward reach outs. Routine back exercises includes 5 sets - pelvic bridges, dynamic dead bug, prone planks, situps, lateral planks. 10Repetition Maximum, 2 Sets/ day, five days a week, 2 weeks. Baseline balance (star Edward, berg balance) and functional test (sit to stand) and pain (Visual analogue score) and post 2 weeks outcome scores will be analysed through paired and unpaired for between and within groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Balance exercise training | Experimental | Behavioral: Balance Exercise TrainingBalance exercise training - thrice week, 2 weeks, 10 repetition Maximum/ set, 2 sets |
| Routine Back exercise Program | Active comparator | Behavioral: Routine Back exercise programRoutine Back exercise Program - 10 Repetition Maximum / set, 2 sets, three times weekly, 2 weeks |
Who may qualify
- Ages
- 25 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- non specific low back pain diagnosed by orthopedical surgeon or physiatrist
- Both genders
- Age 25 - 45 years (to avoid age related balance deficit)
- Should have balance deficit percentage (> 20%) through balance assessment scale
Key exclusion criteria (7 listed)
- H/O Benign Paroxysmal Positional Vertigo
- Neuromuscular disorders(Stroke, Polio, Potts spine, spinal stenosis) affecting balance
- any form of ear infection
- Recent ear, nose, throat surgery
- Recent surgery in abdomen, thorax, head (< 2 years)
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 |
|---|---|---|
| Balance Exercise TrainingBalance exercise - 5 type (single leg squat, dead lift, step ups, forward reaches), 10 Repetition Maximum, 2 sets, five times a week and 2 weeks | Behavioural | Balance exercise training |
| Routine Back exercise programBack strengthening 5 exercises - pelvic bridges, prone plank, side plank, dead bug and prone lift ups, 10 Repetition Maximum, 2 sets, five times a week, 2 weeks | Behavioural | Routine Back exercise Program |
Primary outcome
Starr Edward Balance Test
Time frame: Baseline, 2 weeks
2 secondary outcomes
Berg Balance Scale
Time frame: Baseline, 2 weeks
Visual Analogue score
Time frame: Baseline, 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2014.
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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.
Pavita Devi, BPT principal investigator
Senior Physiotherapist
Baskaran Chandrasekaran, MPT study chair
Senior Physiotherapist
Sumathi Muraleetharan, BPT study chair
Senior Physiotherpist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Balance Exercise Training and Routine Back exercise program in people with Chronic Low Back Pain, run by Baskaran Chandrasekaran at 1 site in India.
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 4 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: status not confirmed, as of the sponsor's last update on 22 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 India. 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Starr Edward Balance Test (time frame: Baseline, 2 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 22 Aug 2014.