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| ID | Type | Description | Link |
|---|---|---|---|
| 15602 (NSD) | |||
| 408/06-301.0 (Fondet) |
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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:
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reduction of pain and/or functional improvement | 3-4 weeks, 2 and 4 months |
| Measure | Description | Time Frame |
|---|---|---|
| Compliance. Patient global impression of change | 3-4 weeks, 2 and 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jan M Bjordal, professor | University of Bergen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Skogli helse- og rehabiliteringssenter | Lillehammer | Lillehammer | 2614 | Norway |
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| 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. |
|
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D004561 | Transcutaneous Electric Nerve Stimulation |
| ID | Term |
|---|---|
| D004599 | Electric Stimulation Therapy |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
| D000698 | Analgesia |
| D000760 | Anesthesia and Analgesia |
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