Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-radiculalgia

Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation (TENS) in Patients With Chronic Low Back Pain or Chronic Lumbo-radiculalgia and Followed in Pain Treatment Centers

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00452010

Acronym

LOBOTENS

Enrollment

236

Registered

2007-03-26

Start date

2006-09-30

Completion date

2008-09-30

Last updated

2012-07-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Low Back Pain, Chronic Lumbo-radiculalgia

Keywords

TENS, chronic low back pain, chronic lumbo-radiculalgia, placebo, Roland scale

Brief summary

Prior studies showed contradictory results about the best type of TENS in chronic pain pathology. Therefore we want to evaluate the efficacy assessment of TENS on patients with chronic low back pain or chronic lumbo-radiculalgia. The functional ability score is evaluated by the Roland scale at 6 weeks.

Interventions

DEVICECEFAR PRIMO TENS Class IIA (active)

Active TENS. 4 sessions per day during 3 months.

DEVICECEFAR PRIMO TENS Class IIA (no active)

Placebo TENS. 4 sessions per day during 3 months.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Stable chronic low back pain or stable chronic lumbo-radiculalgia * Patients with a pain score at least superior or equal to 4 * Patients followed in pain clinics * Written informed consent

Exclusion criteria

* Prior ambulatory TENS practice * Lumbo-radiculalgia pathology surgery within 3 months before inclusion * Acute low back pain or bilateral lumbo-radiculalgia * Acute radiculalgia * Surgery planned within 6 months * Pacemaker * Symptomatic low back pain

Design outcomes

Primary

Measure	Time frame
functional ability	Week 6

Secondary

Measure	Time frame
functional repercussions by Roland scale	Month 3
functional repercussions by Dallas scale	Month 3
quality of life	Day 1 and Month 3
pain relief	Week 6 and Month 3
medical consumption	From Day 1 to Month 3
TENS observance	from Day 1 to Month 3
global satisfaction of cares	Month 3

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026