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

Chronic Low Back Pain Clinical Trial

— LOBOTENS  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00452010
• Other study ID #: 0601001
• Secondary ID: lombotens
• Status: Completed
• Phase: Phase 4
• First received: March 23, 2007
• Last updated: July 3, 2012
• Start date: September 2006
• Est. completion date: September 2008

Study information

• Verified date: September 2008
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Ministry of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 236
• Est. completion date: September 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Chronic Low Back Pain
• Chronic Lumbo-radiculalgia
• Low Back Pain

Intervention

Device:
• CEFAR PRIMO TENS Class IIA (active)
Active TENS. 4 sessions per day during 3 months.
• CEFAR PRIMO TENS Class IIA (no active)
Placebo TENS. 4 sessions per day during 3 months.

Locations

Country	Name	City	State
France	CHU d'Amiens	Amiens
France	CHU de Grenoble	Grenoble
France	CHU de Limoges	Limoges
France	Fondation Hôpital Saint Joseph - MARSEILLE	Marseille
France	La Timone - MARSEILLE	Marseille
France	Centre Catherine de Sienne - Nantes	Nantes
France	CHU de Saint-Etienne	Saint-Etienne Cedex 2
France	CH de Voiron	Voiron

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

References & Publications (1)

Buchmuller A, Navez M, Milletre-Bernardin M, Pouplin S, Presles E, Lantéri-Minet M, Tardy B, Laurent B, Camdessanché JP; Lombotens Trial Group. Value of TENS for relief of chronic low back pain with or without radicular pain. Eur J Pain. 2012 May;16(5):65 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	functional ability		Week 6	No
Secondary	pain relief		Week 6 and Month 3	No
Secondary	functional repercussions by Roland scale		Month 3	No
Secondary	functional repercussions by Dallas scale		Month 3	No
Secondary	quality of life		Day 1 and Month 3	No
Secondary	global satisfaction of cares		Month 3	No
Secondary	medical consumption		From Day 1 to Month 3	No
Secondary	TENS observance		from Day 1 to Month 3	No