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

NCT02343315 | Withdrawn DMC

• 1 other identifier: KUSMS107/14
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Low Back Pain

Keywords

low back pain; home exercises; chronic pain; supervised exercise; core stability exercises; spinal stabilization exercises

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Pain intensity (Numerical Pain Rating Scale (NPRS)

  2 weeks

• Pain intensity (Numerical Pain Rating Scale (NPRS)

  6 months

• Disability (Nepali version of Oswestry Disability Index (NODI)

  6 months

Other Outcomes (7)

• Changes in pain and disability (Global Rating of Change (GROC)

  2 weeks

• Changes in pain and disability (Global Rating of Change (GROC)

  6 months

• Need for medication (using frequency and dosage and types of analgesics used)

  6 months

Study Arms (3)

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.

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.

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.

Other: UHEP

Interventions

TENS DEVICE

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

Also known as: transcutaneous electrical nerve stimulation, transcutenous nerve stimulation, transcutaneous electrical stimulation, Low TENS, Motor level TENS

TENS

SMCE OTHER

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.

Also known as: core stability exercises, spinal stabilization exercises, Supervised motor control exercises

SMCE; TENS

UHEP OTHER

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).

Also known as: home exercise program, Unsupervised home exercise program

SMCE; TENS; UHEP

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead

MeSH Terms

Conditions

Low Back Pain; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Saurab Sharma, MPT

  Kathmandu University School of Medical Sciences, Nepal

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MPT

Study Record Dates

• First Submitted: January 15, 2015
• First Posted: January 22, 2015
• Study Start: August 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: December 1, 2020
• Last Updated: April 6, 2022

Record last verified: 2022-03