Chronic Low Back PainNCT02343315
Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
A study testing TENS, SMCE and UHEP in people with Chronic Low Back Pain, run by Kathmandu University School of Medical Sciences.
Trial summary
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Low Back Pain
- What is being tested?
- TENS, SMCE and UHEP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Aug 2019to Dec 2020
- 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
- Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
- Age between 18 to 65 years
- Male or female
- All educational backgrounds (educated or uneducated)
- Pain intensity more than 2/10 on NPRS and
- Disability of more than 20/100 on NODI
Who cannot join
- Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
- Signs consistent with nerve root compression, this includes any one of the following:
- Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
- Muscle weakness involving a major muscle group of the lower extremity
- Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
- Diminished or absent sensation to pinprick in any lower extremity dermatome
Show all 11Show fewer
- Prior surgery to the lumbar spine or buttock
- Current pregnancy
- Past medical history of osteoporosis or spinal compression fracture
- Participants who do not provide informed consent for the study
- -
About this study
Official title: Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.
Read the detailed description
Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.
- Conditions
- Chronic Low Back Pain
- Being tested
- TENS, SMCE, UHEP
- Keywords
- low back pain, home exercises, chronic pain, supervised exercise, core stability exercises, spinal stabilization exercises
- Medical subject headings
- Low Back Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TENSDevice
Also called transcutaneous electrical nerve stimulation, transcutenous nerve stimulation, transcutaneous electrical stimulation, Low TENS
Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes.
- Equipment- TENS (CEFAR Basic TENS Machine)
- Electrodes- Four channel electrode to cover the site of pain
- Site of electrode placement- will be decided by the physical therapist to best suit or cover the area of pain based on complaints of patient based on the body chart.
- Intensity- the intensity will be increased progressively until maximum tolerable intensity is reached. This stimulation may cause visible muscle contraction. This type of current is also referred to as Motor-level TENS, which is effective for chronic pain. The intensity will not be increased beyond 25 milli Amperes if no sensation is perceived by the patient.
- Frequency- 5 Hertz
- Duration- 30 minutes
SMCEOther
Also called core stability exercises, spinal stabilization exercises, Supervised motor control exercises
Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles.
Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities.
UHEPOther
Also called home exercise program, Unsupervised home exercise program
All the participants will receive the following treatments:
- Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments.
- Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session.
- Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen).
| Study group | Role | What they receive |
|---|---|---|
| TENS | Experimental | Participants will receive Active-TENS along with SMCE and UHEP. Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes. Receives: Device: TENS; Other: SMCE; Other: UHEP |
| SMCE | Experimental | Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks. Receives: Other: SMCE; Other: UHEP |
| UHEP | Active comparator | Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session. Receives: Other: UHEP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability (Nepali version of Oswestry Disability Index (NODI)
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
Measured: 2 weeks
Secondary outcomes (3)
Pain intensity (Numerical Pain Rating Scale (NPRS)
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
Measured: 2 weeks
Pain intensity (Numerical Pain Rating Scale (NPRS)
Numerical Pain Rating Scale (NPRS) - An 11-point numeric pain rating scale ranging from 0 (no pain) to 10 (worst imaginable pain) will be used to assess current pain intensity and the best and worst level of pain during the last 24 hours.
Measured: 6 months
Disability (Nepali version of Oswestry Disability Index (NODI)
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2015 (estimated)
- Study startAug 2019 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionDec 2020 (estimated)
Why it stopped: We were unable to run the trial because of inadequate resources (staffing). The principal investigator also moved countries.
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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kathmandu University School of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurab Sharma, Kathmandu University School of Medical Sciences
- Investigators
- Saurab Sharma, MPT, Principal investigator, Kathmandu University School of Medical Sciences, Nepal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02343315
- Sponsor's protocol ID
- KUSMS107/14
- Status last verified
- Mar 2022
- First submitted
- 15 Jan 2015
- Last updated
- 6 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of TENS and Supervised Motor Control Exercises Compared To Unsupervised Exercises in Subjects With Chronic Low Back Pain: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02343315
- Acronym / sponsor ID
- KUSMS107/14
- Conditions
- Chronic Low Back Pain
- Keywords
- low back pain, home exercises, chronic pain, supervised exercise, core stability exercises, spinal stabilization exercises
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: We were unable to run the trial because of inadequate resources (staffing). The principal investigator also moved countries.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Kathmandu University School of Medical SciencesUniversity, hospital or other
- Study start
- Aug 2019 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 22 Jan 2015 (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.
The purpose of this study is to compare the added effects of TENS and Supervised Motor Control Exercises (SMCE) over Unsupervised Home Exercise Program (UHEP) on disability, pain and other outcomes.
Detailed description
Chronic low back pain (CLBP) is a common problem causing disability and high economic burden in globally as well as in Nepal. There is no consensus on treatment of CLBP, however motor control exercises have good evidence on improvement in pain and disability in CLBP population, whereas transcutaneous electrical nerve stimulation (TENS) is a common treatment of choice with some evidence. But, we do not know if supervising these motor control exercises (SMCE) and TENS have any added benefit over home exercise program (HEP) which is commonly prescribed mode of exercises. We plan to conduct a three armed randomized control trial to answer this question to compare effects of SMCE, TENS and HEP versus SMCE and HEP versus HEP alone on disability and pain at two weeks and six months follow up. Three way-mixed model analysis of Variance (ANOVA) will be used as the statistical test. Appropriate post hoc analysis will be done to compare within group and between group differences.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TENS | Experimental | Device: TENS, Other: SMCE, Other: UHEPParticipants will receive Active-TENS along with SMCE and UHEP. Six treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes. |
| SMCE | Experimental | Other: SMCE, Other: UHEPParticipants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks. |
| UHEP | Active comparator | Other: UHEPUnsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Nonspecific Low back pain for more than 3 months with pain primarily localized between T12 and gluteal folds, if patients report that their pain is provoked and relieved with postures, movement and activities.
- Age between 18 to 65 years
- Male or female
- All educational backgrounds (educated or uneducated)
- Pain intensity more than 2/10 on NPRS and
Key exclusion criteria (11 listed)
- Red flags noted in the participant's general medical screening questionnaire (i.e. tumor, metabolic diseases, Rheumatoid Arthritis, osteoporosis, prolonged history of steroid use, etc.)
- Signs consistent with nerve root compression, this includes any one of the following:
- Prior surgery to the lumbar spine or buttock
- Current pregnancy
- Past medical history of osteoporosis or spinal compression fracture
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 |
|---|---|---|
| TENSAlso: transcutaneous electrical nerve stimulation, transcutenous nerve stimulation, transcutaneous electrical stimulation, Low TENSSix treatment sessions will be given over two weeks. Total duration of the treatment session may last from 40 - 60 minutes. * Equipment- TENS (CEFAR Basic TENS Machine) * Electrodes- Four channel electrode to cover the site of pain * Site of electrode placement- will be decided by the physical therapist to best suit or cover the area of pain based on complaints of patient based on the body chart. * Intensity- the intensity will be increased progressively until maximum tolerable intensity is reached. This stimulation may cause visible muscle contraction. This type of current is also referred to as Motor-level TENS, which is effective for chronic pain. The intensity will not be increased beyond 25 milli Amperes if no sensation is perceived by the patient. * Frequency- 5 Hertz * Duration- 30 minutes | Device | TENS |
| SMCEAlso: core stability exercises, spinal stabilization exercises, Supervised motor control exercisesSix sessions of supervised Motor control exercises will be provided over the period of two weeks. Exercises will be provided in order to target the function of core muscles of the spine. Each participant in the SMCE group will be trained by a physical therapist to recruit the deep muscles of the spine and reduce the activity of superficial muscles. Initially participants will be taught how to contract the transversus abdominis and multifidus muscles in isolation from the more superficial trunk muscles, but in conjunction with the pelvic floor muscles. Pressure biofeedback will be used in order to provide feedback about muscle recruitment to the participant. Exercises will be provided to the participants in the progressive manner. Later, movement of limbs will be incorporated with the contraction of the core muscles. Finally, these core muscle activation will be emphasized during the functional activities. | Other | SMCE, TENS |
| UHEPAlso: home exercise program, Unsupervised home exercise programAll the participants will receive the following treatments: 1. Unsupervised home exercise program- which includes series of motor control exercises along with specific exercises including stretching exercises based on impairments. 2. Education in terms of body mechanics, ergonomics advises and educational leaflet in the form of Nepali version of Back book which includes, evidence based advises about back pain self-management, advice to remain active. Treating physical therapist will educate all the participants in the first intervention session. 3. Participants will not be asked to not take the "over the counter" analgesics including Acetaminophen or Non-inflammatory anti-inflammatory drugs (ibuprofen). | Other | SMCE, TENS, UHEP |
Primary outcome
Disability (Nepali version of Oswestry Disability Index (NODI)
Time frame: 2 weeks
Nepali version of Oswestry Disability Index (NODI) will be used to measure disability which is a cross culturally adapted and validated tool for measuring disability in low back pain population in Nepal. The tool has acceptable reliability (Cronbach's Alpha= 0.723, intraclass correlation coefficient= 0.875)
3 secondary outcomes
Pain intensity (Numerical Pain Rating Scale (NPRS)
Time frame: 2 weeks
Pain intensity (Numerical Pain Rating Scale (NPRS)
Time frame: 6 months
Disability (Nepali version of Oswestry Disability Index (NODI)
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2022.
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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.
Saurab Sharma, MPT principal investigator
Kathmandu University School of Medical Sciences, Nepal
Questions about this trial
What is this clinical trial studying?
A study testing TENS, SMCE and UHEP in people with Chronic Low Back Pain, run by Kathmandu University School of Medical Sciences.
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 11 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: withdrawn, as of the sponsor's last update on 6 Apr 2022. 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 was withdrawn before enrolling participants, so there are no results.
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?
Disability (Nepali version of Oswestry Disability Index (NODI) (time frame: 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 6 Apr 2022.