Clinical trial NCT02343315: 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
Overall status: WITHDRAWN
Phase: NA
Conditions: Chronic Low Back Pain
Keywords: low back pain
home exercises
chronic pain
supervised exercise
core stability exercises
spinal stabilization exercises
Lead sponsor: Kathmandu University School of Medical Sciences
Sponsor class: OTHER
First posted: 2015-01-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. 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.
2. Age between 18 to 65 years
3. Male or female
4. All educational backgrounds (educated or uneducated)
5. Pain intensity more than 2/10 on NPRS and
6. Disability of more than 20/100 on NODI

Exclusion Criteria:

1. 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.)
2. Signs consistent with nerve root compression, this includes any one of the following:

   1. Reproduction of low back or leg pain with straight leg raise at less than 45 degrees
   2. Muscle weakness involving a major muscle group of the lower extremity
   3. Diminished lower extremity muscle stretch reflex (Quadriceps or Achilles tendon)
   4. Diminished or absent sensation to pinprick in any lower extremity dermatome
3. Prior surgery to the lumbar spine or buttock
4. Current pregnancy
5. Past medical history of osteoporosis or spinal compression fracture
6. Participants who do not provide informed consent for the study

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Primary outcomes:
measure: Disability (Nepali version of Oswestry Disability Index (NODI)
timeFrame: 2 weeks
Secondary outcomes:
measure: Pain intensity (Numerical Pain Rating Scale (NPRS)
timeFrame: 2 weeks
measure: Pain intensity (Numerical Pain Rating Scale (NPRS)
timeFrame: 6 months
measure: Disability (Nepali version of Oswestry Disability Index (NODI)
timeFrame: 6 months
Other outcomes:
measure: Changes in pain and disability (Global Rating of Change (GROC)
timeFrame: 2 weeks
measure: Changes in pain and disability (Global Rating of Change (GROC)
timeFrame: 6 months
measure: Need for medication (using frequency and dosage and types of analgesics used)
timeFrame: 6 months
measure: Need for follow up (number of treatment sessions in past six months will be recorded)
timeFrame: 6 months
measure: Adverse events
timeFrame: 6 months
measure: Fear avoidance (Fear avoidance belief questionnaire (FABQ)
timeFrame: 6 months
measure: Pain Catastrophizing (Pain catastrophizing Scale (PCS)
timeFrame: 6 months
Locations:
Study officials:
affiliation: Kathmandu University School of Medical Sciences, Nepal
name: Saurab Sharma, MPT
role: PRINCIPAL_INVESTIGATOR
References: