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

NCT ID: NCT02343315

Last Updated: 2022-04-06

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-31
• Study Completion Date: 2020-12-31

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.

Conditions

Chronic Low Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

TENS

Intervention Type: 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

SMCE

Intervention Type: 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.

UHEP

Intervention Type: 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).

SMCE

Participants will receive SMCE and UHEP. Six sessions of supervised Motor control exercises will be provided over the period of two weeks.

Group Type: EXPERIMENTAL

SMCE

Intervention Type: 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.

UHEP

Intervention Type: 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).

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.

Group Type: ACTIVE_COMPARATOR

UHEP

Intervention Type: 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).

Interventions

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

Intervention Type: DEVICE

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.

Intervention Type: 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).

Intervention Type: OTHER

Other Intervention Names

transcutaneous electrical nerve stimulation; transcutenous nerve stimulation; transcutaneous electrical stimulation; Low TENS; Motor level TENS; core stability exercises; spinal stabilization exercises; Supervised motor control exercises; home exercise program; Unsupervised home exercise program

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kathmandu University School of Medical Sciences

OTHER

Sponsor Role: lead

Responsible Party

Saurab Sharma

MPT

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Saurab Sharma, MPT

Role: PRINCIPAL_INVESTIGATOR

Kathmandu University School of Medical Sciences, Nepal

Other Identifiers

KUSMS107/14

Identifier Type: -

Identifier Source: org_study_id