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

Norwegian Fund for Postgraduate Training in Physiotherapy

Status: Completed

Conditions: Neuropathic Pain

Treatments: Device: Cefar Primo Pro TENS device; Device: Transcutaneous Nerve Stimulation (TENS)

Study type: Interventional

Funder types: Other

Identifiers

NCT00716326

15602 (NSD)

8589 (REK)

408/06-301.0 (Fondet)

Details and patient eligibility

About

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.

Full 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).

Enrollment: 115 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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115 participants in 2 patient groups, including a placebo group

1

Active Comparator group

Description:

Subjects in this study arm will receive active treatment with Cefar TENS device which delivers therapeutic electrical currents 2-3x over sensory threshold in the area of pain.

Treatment:

Device: Transcutaneous Nerve Stimulation (TENS)

Device: Cefar Primo Pro TENS device

2

Placebo Comparator group

Description:

Subjects in this study arm will receive placebo treatment with manipulated Cefar TENS device which delivers electrical currents just below sensory threshold in the area of pain.

Treatment:

Device: Cefar Primo Pro TENS device