The Use of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Pain of Predominantly Peripheral Neuropathic Origin
NCT ID: NCT00716326
Last Updated: 2008-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
115 participants
INTERVENTIONAL
2007-01-31
2008-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
1
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.
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.
2
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.
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
Exclusion Criteria
* Surgery or lesion within 3 months
* Central neuropathic pain
* Fibromyalgia
* Primary headaches
* Primary psychiatric diagnosis
* Patients with pacemaker
* Formerly treated with TENS
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Norwegian Fund for Postgraduate Training in Physiotherapy
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jan M Bjordal, professor
Role: STUDY_DIRECTOR
University of Bergen
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Skogli helse- og rehabiliteringssenter
Lillehammer, Lillehammer, Norway
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
15602 (NSD)
Identifier Type: -
Identifier Source: secondary_id
408/06-301.0 (Fondet)
Identifier Type: -
Identifier Source: secondary_id
8589 (REK)
Identifier Type: -
Identifier Source: org_study_id