Are Supervised Exercises and TENS Necessary Along With Prescribed Home Exercises for Chronic Low Back Pain?

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.

Study Overview

• Status: Withdrawn
• Conditions: Chronic Low Back Pain
• Intervention / Treatment: Device: TENS; Other: SMCE; Other: UHEP

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 Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

   -

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TENS; 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.	Device: 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; Other Names: transcutaneous electrical nerve stimulation; transcutaneous electrical stimulation; transcutenous nerve stimulation; Low TENS; Motor level TENS; Other: SMCE; 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.; Other Names: core stability exercises; spinal stabilization exercises; Supervised motor control exercises; Other: UHEP; 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).; Other Names: home exercise program; Unsupervised home exercise program
Experimental: SMCE; Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.	Other: SMCE; 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.; Other Names: core stability exercises; spinal stabilization exercises; Supervised motor control exercises; Other: UHEP; 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).; Other Names: home exercise program; Unsupervised home exercise program
Active Comparator: UHEP; Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.	Other: UHEP; 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).; Other Names: home exercise program; Unsupervised home exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	2 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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)	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain and disability (Global Rating of Change (GROC)	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.	2 weeks
Changes in pain and disability (Global Rating of Change (GROC)	Using Global rating of change (GROC)	6 months
Need for medication (using frequency and dosage and types of analgesics used)	using frequency and dosage and types of analgesics used	6 months
Need for follow up (number of treatment sessions in past six months will be recorded)	number of treatment sessions in past six months will be recorded	6 months
Adverse events	numbers of adverse events are noted down using a questionnaire	6 months
Fear avoidance (Fear avoidance belief questionnaire (FABQ)	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.	6 months
Pain Catastrophizing (Pain catastrophizing Scale (PCS)	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').	6 months

Collaborators and Investigators

• Sponsor: Kathmandu University School of Medical Sciences
• Investigators: Principal Investigator: Saurab Sharma, MPT, Kathmandu University School of Medical Sciences, Nepal

Study record dates

Study Major Dates

• Study Start (Anticipated): August 1, 2019
• Primary Completion (Anticipated): September 1, 2020
• Study Completion (Anticipated): December 1, 2020

Study Registration Dates

• First Submitted: January 15, 2015
• First Submitted That Met QC Criteria: January 21, 2015
• First Posted (Estimate): January 22, 2015

Study Record Updates

• Last Update Posted (Actual): April 6, 2022
• Last Update Submitted That Met QC Criteria: March 28, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: chronic pain; low back pain; home exercises; supervised exercise; core stability exercises; spinal stabilization exercises
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: KUSMS107/14

Drug and device information, study documents

• 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