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Completed

NCT Number: NCT00716326

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

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.

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Key information

Conditions

Neuropathic Pain Chronic Pain Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Skogli helse- og rehabiliteringssenter

Lillehammer, 2614, Norway

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transcutaneous Nerve Stimulation (TENS)

Device

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

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.

Primary outcomes

  1. Reduction of pain and/or functional improvement

    Time frame: 3-4 weeks, 2 and 4 months

Secondary outcomes

  1. Compliance. Patient global impression of change

    Time frame: 3-4 weeks, 2 and 4 months

Sponsors and collaborators

Lead sponsor

Norwegian Fund for Postgraduate Training in Physiotherapy

Other

Registry information

Important dates

Study start
2007
Primary completion
2008
Study completion
2008
First posted
Jul 16, 2008
Registry last updated
Dec 18, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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