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

NCT00716326 | Completed

• 3 other identifiers: 8589 (REK)15602 (NSD)408/06-301.0 (Fondet)
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Neuropathic Pain

Keywords

Transcutaneous Electrical Nerve Stimulation; Chronic pain; Neuropathic pain; Short-term efficacy; Long-term efficacy

Outcome Measures

Primary Outcomes (1)

• Reduction of pain and/or functional improvement

  3-4 weeks, 2 and 4 months

Secondary Outcomes (1)

• Compliance. Patient global impression of change

  3-4 weeks, 2 and 4 months

Study Arms (2)

1

ACTIVE COMPARATOR

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.

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

2

PLACEBO COMPARATOR

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.

Device: Cefar Primo Pro TENS device

Interventions

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.

1

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.

1; 2

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients with chronic pain of predominantly neuropathic origin

You may not qualify if:

• 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

Sponsors & Collaborators

• Norwegian Fund for Postgraduate Training in Physiotherapy: lead

Study Sites (1)

Skogli helse- og rehabiliteringssenter

Lillehammer, Lillehammer, 2614, Norway

Location

MeSH Terms

Conditions

Neuralgia; Chronic Pain

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Study Officials

• Jan M Bjordal, professor

  University of Bergen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: July 9, 2008
• First Posted: July 16, 2008
• Study Start: January 1, 2007
• Primary Completion: September 1, 2008
• Study Completion: December 1, 2008
• Last Updated: December 18, 2008

Record last verified: 2008-12

Locations

NO (1)