Neuropathic Pain
Conditions
Keywords
Transcutaneous Electrical Nerve Stimulation, Chronic pain, Neuropathic pain, Short-term efficacy, Long-term efficacy
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.
Detailed 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).
Interventions
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.
DEVICECefar 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.
Sponsors
Norwegian Fund for Postgraduate Training in Physiotherapy
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction of pain and/or functional improvement | 3-4 weeks, 2 and 4 months |
Secondary
| Measure | Time frame |
|---|---|
| Compliance. Patient global impression of change | 3-4 weeks, 2 and 4 months |
Countries
Norway
Outcome results
None listed