Back to resultsAre Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
Primary Purpose
Chronic Low Back Pain
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
TENS
SMCE
UHEP
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Low Back Pain focused on measuring low back pain, home exercises, chronic pain, supervised exercise, core stability exercises, spinal stabilization exercises
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
-
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
TENS
SMCE
UHEP
Arm Description
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.
Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
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.
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)
Full Information
NCT ID
NCT02343315
First Posted
January 15, 2015
Last Updated
March 28, 2022
Sponsor
Kathmandu University School of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02343315
Brief Title
Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
We were unable to run the trial because of inadequate resources (staffing). The principal investigator also moved countries.
Study Start Date
August 2019 (Anticipated)
Primary Completion Date
September 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kathmandu University School of Medical Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
low back pain, home exercises, chronic pain, supervised exercise, core stability exercises, spinal stabilization exercises
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
SMCE
Arm Type
Experimental
Arm Description
Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.
Arm Title
UHEP
Arm Type
Active Comparator
Arm Description
Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.
Intervention Type
Device
Intervention Name(s)
TENS
Other Intervention Name(s)
transcutaneous electrical nerve stimulation, transcutenous nerve stimulation, transcutaneous electrical stimulation, Low TENS, Motor level TENS
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
SMCE
Other Intervention Name(s)
core stability exercises, spinal stabilization exercises, Supervised motor control exercises
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
UHEP
Other Intervention Name(s)
home exercise program, Unsupervised home exercise program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Disability (Nepali version of Oswestry Disability Index (NODI)
Description
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)
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Pain intensity (Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
2 weeks
Title
Pain intensity (Numerical Pain Rating Scale (NPRS)
Description
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.
Time Frame
6 months
Title
Disability (Nepali version of Oswestry Disability Index (NODI)
Description
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)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Changes in pain and disability (Global Rating of Change (GROC)
Description
Global Rating of Change (GROC) - The fifteen-point global rating scale will be used. The scale ranges from -7 (a very great deal worse) to zero (about the same) to +7 (a very great deal better). Intermittent descriptors of worsening or improving are assigned values from -1 to -6 and +1 to +6 respectively. The global rating will be administered at the follow-up examinations only.
Time Frame
2 weeks
Title
Changes in pain and disability (Global Rating of Change (GROC)
Description
Using Global rating of change (GROC)
Time Frame
6 months
Title
Need for medication (using frequency and dosage and types of analgesics used)
Description
using frequency and dosage and types of analgesics used
Time Frame
6 months
Title
Need for follow up (number of treatment sessions in past six months will be recorded)
Description
number of treatment sessions in past six months will be recorded
Time Frame
6 months
Title
Adverse events
Description
numbers of adverse events are noted down using a questionnaire
Time Frame
6 months
Title
Fear avoidance (Fear avoidance belief questionnaire (FABQ)
Description
Fear avoidance belief questionnaire (FABQ) - The FABQ is a 16-item scale that assesses the influence of fear avoidance behaviors on physical and work activities. Each item is scored from 0-6 with possible scores ranging between 0-42 and higher scores representing increased fear-avoidance beliefs.
Time Frame
6 months
Title
Pain Catastrophizing (Pain catastrophizing Scale (PCS)
Description
Pain catastrophizing Scale (PCS) - Nepali translation of PCS is a 13-item scale that assesses the pain catastrophizing. Pain catastrophizing is an exaggerated, negative focus on pain and is related to psychological distress, pain severity, and other negative outcomes in pain population. Participants responded to each item using a Likert-type scale from 0 ('not at all') to 4 ('all the time').
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Saurab Sharma, MPT
Organizational Affiliation
Kathmandu University School of Medical Sciences, Nepal
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?
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