Effects of Thermotherapy on Chronic Neck Pain

• ClinicalTrials.gov Identifier: NCT01304368
• Recruitment Status: Completed
• First Posted: February 25, 2011
• Last Update Posted: February 25, 2011
• Sponsor: Universität Duisburg-Essen
• Information provided by: Universität Duisburg-Essen

Tracking Information

• First Submitted Date: February 24, 2011
• First Posted Date: February 25, 2011
• Last Update Posted Date: February 25, 2011
• Study Start Date: August 2009
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 24, 2011)

Neck pain intensity (100mm visual analog scale) [ Time Frame: Day 14 ]

100mm visual analog scale

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: February 24, 2011)

• Pain related to motion [ Time Frame: Day 14 ]
  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 ]
  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 ]
  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 ]
  100mm visual analog scale for rating neck pain intensity each day
• Pressure pain threshold [ Time Frame: Day 14 ]
  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 ]
  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 ]
  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 ]
  Open question on any side effects or other experiences with the treatment
• Medication and additional treat ment use [ Time Frame: Day 14 ]
  Patient report used medication or additional treatment during the study period

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Effects of Thermotherapy on Chronic Neck Pain
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Primary Purpose: Treatment
• Condition: Neck Pain

Intervention

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 Arms

• 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

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: February 24, 2011): 50
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2010
• Actual Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Germany

Administrative Information

• NCT Number: NCT01304368
• Other Study ID Numbers: 09-3953
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Gustav J Dobos, MD, Universität Duisburg-Essen, Chair of Complementary and Integrative Medicine
• Original Responsible Party: Same as current
• Current Study Sponsor: Universität Duisburg-Essen
• Original Study Sponsor: Same as current
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Universität Duisburg-Essen
• Verification Date: February 2011