NCT02343315

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

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Kathmandu University School of Medical Sciences · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Chronic Low Back Pain

Interventions

Type	Name	Description
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	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	UHEP	All 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).

Timeline

• Start date: 2019-08-01
• Primary completion: 2020-09-01
• Completion: 2020-12-01
• First posted: 2015-01-22
• Last updated: 2022-04-06