Chronic pain (non-cancer) Signs and Symptoms
Conditions
Interventions
Patients will be randomised to receive either:
1. Transcutaneous electrical nerve stimulation (TENS): pulse frequency is set to 80 Hz and pulse width to 0.50 ms, intensity: strong tingling, not pricki
same device and application, however no current to the electrodes.
Both groups receive daily treatments for a maximum period of one year.
Sponsors
The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients with chronic non-cancer pain referred to the Pain Centre 2. Duration of pain greater than 6 months 3. Age above 18 years, male and female
Exclusion criteria
Exclusion criteria: 1. Previous TENS treatment 2. Pain in face or head 3. Several unrelated sites of pain 4. History of a cerebral vascular accident 5. No assistance at home - e.g. relatives or friends - to help replace or connect the electrodes 6. Involvement in ongoing litigation because of their pain 7. Psychological intervention proposed by the Pain Centre psychologists
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients satisfied with treatment result and willing to continue treatment. From patients who ceased treatment because they were no longer satisfied with treatment result, the date of cessation of treatment is used for survival analysis. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Overall improvement: a percentage change from baseline; nil percent meaning no improvement at all and hundred percent meaning complete recovery. 2. Pain intensity is measured with a 10-centimeter long Visual Analogue Scale (VAS). Descriptors at the beginning and at the end of the scale are 'no pain at all' and 'maximal imaginable pain'. Patients rate their pain at the same time every day for one week. 3. Perceived health status is measured by the sickness impact profile (SIP). The SIP was developed to provide a measure of perceived health status that is sensitive enough to detect changes or differences in heath status that occur over time or between groups. The SIP contains 136 statements about health-related dysfunction in twelve areas of activity (sleep and rest, eating, work, home management, recreation and pastimes, ambulation, mobility, body care and movement, social interaction, alertness behavior, emotional behavior and communication. 4. Disability because of pain is measured with the Dutch version of the Pain Disability Index (PDI). The PDI was developed as a brief, self-report indicator of pain-related disability. It was constructed as a 7-item questionnaire, which is scored on a scale of 0 (no disability) to 10 (total disability). The items ask for the level of limitations in the total range of role functioning: family/home responsibilities, recreation, social activities, occupation, sexual behavior, self-care and life-supporting activities. 5. Duration of TENS use (hours) serves as a measure for compliance. Duration of actual use of the device, is registered during each visit; it can be read out by pressing a special key combination. 6. Placebo credibility is assessed after the initial treatment period (short-term effect) by asking the patients how certain they feel about having a TENS or placebo device, using a questionnaire according to Deyo et al. 7. Co-intervention: Registration of pain medication: The used daily dose/ the defined daily dose ratio | — |
Countries
Netherlands
Outcome results
None listed