Pain Reducing Effect of Transcutaneous Electrical Nerve Stimulation in Patients With Chronic Low Back Pain or Lumbo-Radiculalgia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Chronic Low Back Pain Chronic Lumbo-Radiculalgia	Device: CEFAR PRIMO TENS Class IIA (active) Device: CEFAR PRIMO TENS Class IIA (no active)	Phase IV

MedlinePlus related topics:

Back Pain

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	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

Further study details as provided by Centre Hospitalier Universitaire de Saint Etienne:

Primary Outcome Measures:

functional ability [ Time Frame: Week 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

pain relief [ Time Frame: Week 6 and Month 3 ] [ Designated as safety issue: No ]
functional repercussions by Roland scale [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
functional repercussions by Dallas scale [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
quality of life [ Time Frame: Day 1 and Month 3 ] [ Designated as safety issue: No ]
global satisfaction of cares [ Time Frame: Month 3 ] [ Designated as safety issue: No ]
medical consumption [ Time Frame: From Day 1 to Month 3 ] [ Designated as safety issue: No ]
TENS observance [ Time Frame: from Day 1 to Month 3 ] [ Designated as safety issue: No ]

Enrollment:	236
Study Start Date:	September 2006
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental transcutaneous electrical nerve stimulation	Device: CEFAR PRIMO TENS Class IIA (active) Active TENS. 4 sessions per day during 3 months.
2: Placebo Comparator No transcutaneous electrical nerve stimulation	Device: CEFAR PRIMO TENS Class IIA (no active) Placebo TENS. 4 sessions per day during 3 months.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00452010

Locations


France
	CHU de Saint-Etienne
	Saint-Etienne Cedex 2, France, 42055
	CHU de Grenoble
	GRENOBLE, France, 38000
	CHU de Limoges
	LIMOGES, France, 87000
	La Timone - MARSEILLE
	MARSEILLE, France, 13000
	Centre Catherine de Sienne - Nantes
	NANTES, France, 44000
	CH de Voiron
	VOIRON, France, 38500
	CHU d'Amiens
	AMIENS, France, 80000
	Fondation Hôpital Saint Joseph - MARSEILLE
	MARSEILLE, France, 13000

Sponsors and Collaborators

Centre Hospitalier Universitaire de Saint Etienne

Ministry of Health, France

Investigators


Principal Investigator:	Bernard LAURENT, Professor	Unaffiliated

More Information

Responsible Party:	CHU de Saint-Etienne ( Françoise LORCA )
Study ID Numbers:	0601001, lombotens
First Received:	March 23, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00452010
Health Authority:	France: Ministry of Health

Keywords provided by Centre Hospitalier Universitaire de Saint Etienne:

TENS

chronic low back pain

chronic lumbo-radiculalgia

placebo

Roland scale

Study placed in the following topic categories:

Signs and Symptoms

Neurologic Manifestations

Low Back Pain

Pain

Back Pain

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 20, 2008

Sponsors and Collaborators:	Centre Hospitalier Universitaire de Saint Etienne Ministry of Health, France
Information provided by:	Centre Hospitalier Universitaire de Saint Etienne
ClinicalTrials.gov Identifier:	NCT00452010