The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

Neuropathic Pain Clinical Trial

Official title:

The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00716326
• Other study ID #: 8589 (REK)
• Secondary ID: 15602 (NSD)408/0
• Status: Completed
• Phase: N/A
• First received: July 9, 2008
• Last updated: December 17, 2008
• Start date: January 2007
• Est. completion date: December 2008

Study information

• Verified date: December 2008
• Source: Norwegian Fund for Postgraduate Training in Physiotherapy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data ServicesNorway: Norwegian Institute of Public Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to investigate the effectiveness of TENS in addition to routine care in patients with chronic pain of predominantly neuropathic origin, compared to treatment with routine care alone."

Hypothesis:

An eventually neuropathic pain component is needed to be identified and alleviated in chronic pain patients to improve the quality of rehabilitation.

0-hypothesis:

• TENS is not better than than placebo, medication or standard rehabilitation program.

• A neuropathic pain component does not demand special considerations in rehabilitation of chronic pain patients.

Description:

Setting:

Skogli helse- og rehabiliteringssenter, Lillehammer, Norway. Center of Rehabilitation for chronic pain patients, rheumatic diseases and orthopedic postoperative patients.

Duration:

Until 18 months of intervention + 6 months of follow up and preparation.

Intervention:

Use of TENS during 3-4 weeks of hospitalization connected to multimodal rehabilitation (short-term efficacy). TENS or placebo-TENS is added to routine care.

Follow-up:

If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months. Questionnaires will be send at 2 and 4 months, both for the active group, the placebo group and for the group of patients who discontinued the use of TENS/placebo-TENS (long-term efficacy).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 115
• Est. completion date: December 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Adult patients with chronic pain of predominantly neuropathic origin

Exclusion Criteria:

• Pain less than 3 months

• Surgery or lesion within 3 months

• Central neuropathic pain

• Fibromyalgia

• Primary headaches

• Primary psychiatric diagnosis

• Patients with pacemaker

• Formerly treated with TENS

Study Design

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

Related Conditions & MeSH terms

• Chronic Pain
• Neuralgia
• Neuropathic Pain

Intervention

Device:
• Transcutaneous Nerve Stimulation (TENS)
Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. The TENS will be used during 3-4 weeks of hospitalization. If patients want to continue the use of TENS/placebo-TENS at home, they will be offered to borrow equipment for 4 months.
• Cefar Primo Pro TENS device
Patients will be randomly allocated to a group with active-TENS and exercises, or to a group with placebo-TENS and exercises. Active TENS: high-frequency modulated pulse duration stimulation Placebo TENS: manipulated device with impulses near sensory threshold.

Locations

Country	Name	City	State
Norway	Skogli helse- og rehabiliteringssenter	Lillehammer

Sponsors (1)

Lead Sponsor	Collaborator
Norwegian Fund for Postgraduate Training in Physiotherapy

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of pain and/or functional improvement		3-4 weeks, 2 and 4 months	No
Secondary	Compliance. Patient global impression of change		3-4 weeks, 2 and 4 months	No