Effects of Thermotherapy on Chronic Neck Pain

This study has been completed.

Sponsor:

Information provided by:

Universität Duisburg-Essen

ClinicalTrials.gov Identifier:

NCT01304368

First received: February 24, 2011

Last updated: NA

Last verified: February 2011

History: No changes posted

Tracking Information
First Received Date ^ICMJE	February 24, 2011
Last Updated Date	February 24, 2011
Start Date ^ICMJE	August 2009
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 24, 2011)	Neck pain intensity (100mm visual analog scale) [ Time Frame: Day 14 ] [ Designated as safety issue: No ] 100mm visual analog scale
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	No Changes Posted
Current Secondary Outcome Measures ^ICMJE (submitted: February 24, 2011)	Pain related to motion [ Time Frame: Day 14 ] [ Designated as safety issue: No ] 100mm visual analog scale for 6 movement directions (flexion, extension, rotation right/left, lateral flexion right/left) Reference: Irnich D, Behrens N, Molzen H, König A, Gleditsch J, Krauss M, Natalis M, Senn E, Beyer A, Schöps P. Randomised trial of acupuncture compared with conventional massage and "sham" laser acupuncture for treatment of chronic neck pain. BMJ. 2001 Jun 30;322(7302):1574-8. Neck disability index (NDI) [ Time Frame: Day 14 ] [ Designated as safety issue: No ] The Neck Disability Index is an instrument to assess neck pain complaints. Reference: Vernon H, Mior S. The Neck Disability Index: a study of reliability and validity. J Manipulative Physiol Ther 1991;14:409-415. SF-36 [ Time Frame: Day 14 ] [ Designated as safety issue: No ] The SF-36 is a short-form health survey consisting of 8 scales (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, mental health) measuring functional health and well-being as well as a physical a and mental health component scores. Reference: Bullinger M, Kirchberger I. SF-36 Fragebogen zum Gesundheitszustand. Göttingen: Hogrefe, 1998. Pain diary [ Time Frame: From day 1 to day 14 ] [ Designated as safety issue: No ] 100mm visual analog scale for rating neck pain intensity each day Pressure pain threshold [ Time Frame: Day 14 ] [ Designated as safety issue: No ] Pressure pain threshold measured at two individual points at the neck: (1) at the point of maximal pain and (2) in the adjacent region, one to two cm outside the painful area and at both hands, serving as control sites. Measurement procedure according to the protocol of QST. Reference: Rolke R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain 2006;123:231-243. Vibration detection threshold [ Time Frame: Day 14 ] [ Designated as safety issue: No ] Vibration detection threshold measured at two individual points at the neck: (1) at the point of maximal pain and (2) in the adjacent region, one to two cm outside the painful area and at both hands, serving as control sites. Measurement procedure according to the protocol of QST. Reference: Rolke R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain 2006;123:231-243. Mechanical detection threshold [ Time Frame: Day 14 ] [ Designated as safety issue: No ] Mechanical detection threshold measured at two individual points at the neck: (1) at the point of maximal pain and (2) in the adjacent region, one to two cm outside the painful area and at both hands, serving as control sites. Measurement procedure according to the protocol of QST. Reference: Rolke R et al. Quantitative sensory testing in the German Research Network on Neuropathic Pain (DFNS): standardized protocol and reference values. Pain 2006;123:231-243. Side effects [ Time Frame: Day 14 ] [ Designated as safety issue: Yes ] Open question on any side effects or other experiences with the treatment Medication and additional treat ment use [ Time Frame: Day 14 ] [ Designated as safety issue: No ] Patient report used medication or additional treatment during the study period
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effects of Thermotherapy on Chronic Neck Pain
Official Title ^ICMJE	Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
Brief Summary	Chronic neck pain is a common worldwide problem. In the majority of cases, patients are treated by medication, referral to a physiotherapist or thermotherapy. Thermotherapy - the therapeutic application of topical heat - provides an easy to apply self-help strategy in patients with chronic neck pain. However, despite the frequent use in clinical practice, there is no research regarding this topic yet. The aim of this study was to evaluate whether thermotherapy self-treatment for chronic neck pain induces changes in perceived pain intensity and in sensory processing.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Primary Purpose: Treatment
Condition ^ICMJE	Neck Pain
Intervention ^ICMJE	Procedure: Thermotherapy Patients are instructed to heat a moor mud filled heat pad (beinio®therm, bb med. product GmbH, Kalkar (Kehrum), Germany) to a hot, but tolerable temperature and to apply it over the painful area once a day for 20 minutes during a period of 14 days. Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.
Study Arm (s)	Active Comparator: Thermotherapy Patients are instructed to heat a moor mud filled heat pad (beinio®therm, bb med. product GmbH, Kalkar (Kehrum), Germany) to a hot, but tolerable temperature and to apply it over the painful area once a day for 20 minutes during a period of 14 days. Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period. Intervention: Procedure: Thermotherapy No Intervention: Waiting list Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	50
Completion Date	August 2010
Primary Completion Date	August 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: non-specific neck pain the last 3 months mean pain intensity of at least 4 on a 10-level numerical rating scale with "0" meaning "no pain" and "10" meaning "worst pain imaginable" Exclusion Criteria: radicular symptoms congenital spine deformity skin diseases in the painful area to be treated pregnancy insulin-dependent diabetes mellitus rheumatic diseases oncologic diseases steroid medication anticoagulation medication recent invasive or surgical treatment of the spine
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Germany

Administrative Information
NCT Number ^ICMJE	NCT01304368
Other Study ID Numbers ^ICMJE	09-3953
Has Data Monitoring Committee	No
Responsible Party	Gustav J Dobos, MD, Universität Duisburg-Essen, Chair of Complementary and Integrative Medicine
Study Sponsor ^ICMJE	Universität Duisburg-Essen
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Universität Duisburg-Essen
Verification Date	February 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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