The effects of transcutaneous electrical nerve stimulation (TENS) on pain and disabilities in the treatment of patients with chronic pain

ISRCTN	ISRCTN32619262
DOI	https://doi.org/10.1186/ISRCTN32619262
Secondary identifying numbers	N/A

Submission date: 15/09/2010
Registration date: 27/09/2010
Last edited: 20/11/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Signs and Symptoms

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Jan Oosterhof
Scientific

Radboud University Nijmegen Medical Centre
645 Department of Physiotherapy
Geert Grooteplein 10
Nijmegen
6500 HB
Netherlands

Study information

Study design	Single centre prospective double blind randomised placebo controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Treatment
Participant information sheet	Not available in web format, please use contact details below to request a patient information sheet
Scientific title	The short and long-term effects of transcutaneous electrical nerve stimulation (TENS) on pain and disabilities in the treatment of patients with chronic benign pain: a randomised double-blind placebo (sham TENS) controlled clinical trial
Study objectives	Transcutaneous electrical nerve stimulation (TENS) is an easy to use analgesic intervention for the treatment of pain. However, although TENS treatment exists since the early 1970s, for chronic pain its effects are still inconclusive. Importantly, It is assumed that the analgesic effect of TENS declines in time by repeated application, threatening the use for chronic pain. Furthermore, it is assumed that improvements lasting for more than three months cannot be attributed to placebo effects. However, long-term randomised placebo controlled TENS studies with treatment periods of more than three months, have not been executed. We therefore explored the short and long-term time courses of the analgesic effects of repeated TENS application compared to sham TENS in patients with chronic pain, for a maximum period of one year.
Ethics approval(s)	The committee for Research on Human Subjects of Arnhem-Nijmegen (Commissie Mensgebonden Onderzoek Regio Arnhem-Nijmegen), Radboud University Nijmegen Medical Centre approved on the 7th May 1999 (ref: CWOM-nr.: 9906-0116)
Health condition(s) or problem(s) studied	Chronic pain (non-cancer)
Intervention	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 pricking sensation. Electrode placement at the sites of hyperalgesia. 2. Placebo: Sham-TENS; same device and application, however no current to the electrodes. Both groups receive daily treatments for a maximum period of one year.
Intervention type	Other
Primary outcome measure	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 outcome measures	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 is used to calculate the drug load in treatment groups, as published by the World Health Organization (http://www.whocc.no/atcddd/). 8. Adverse effects: Patients are asked to report problems with device or electrodes and are instructed to recognize symptoms of allergy of electrode materials. Data collection is performed from patients, as long as they are satisfied with treatment result, for a maximum period of one year. At three, six and 12 months after the initial treatment period patients, still satisfied with treatment result, are invited to the outpatient clinic for assessing pain disability, perceived health status and for retrieving data from previous TENS use. Every month, pain diaries are sent by mail to register pain intensity and pain medication use during one week.
Overall study start date	01/01/2000
Completion date	26/01/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	165
Key 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
Key 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
Date of first enrolment	01/01/2000
Date of final enrolment	26/01/2004

Locations

Countries of recruitment

Netherlands

Study participating centre

Radboud University Nijmegen Medical Centre

Nijmegen
6500 HB
Netherlands

Sponsor information

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands)
Research organisation

Laan van Nieuw Oost Indië 334
Den Haag
2593 CE
Netherlands

Website	http://<www.zonmw.nl
"ROR"	https://ror.org/01yaj9a77

Funders

Funder type

Research organisation

The Netherlands Organization for Health Research and Development (ZonMw) (Netherlands) (ref: 940-31-053)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	01/09/2006	Yes	No
Results article	results	01/05/2008	Yes	No
Results article	results	01/09/2012	Yes	No