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

Kathmandu University School of Medical Sciences

Status: Withdrawn

Conditions: Chronic Low Back Pain

Treatments: Other: SMCE; Device: TENS; Other: UHEP

Study type: Interventional

Funder types: Other

Identifiers

NCT02343315

KUSMS107/14

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

0 participants in 3 patient groups

TENS

Experimental group

Description:

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.

Treatment:

Other: UHEP

Device: TENS

Other: SMCE

SMCE

Experimental group

Description:

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

Treatment:

Other: UHEP

Other: SMCE

UHEP

Active Comparator group

Description:

Unsupervised home exercise program will be prescribed with home exercise leaflet and education leaflet in the form of back book on first treatment session.

Treatment:

Other: UHEP