We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Thermotherapy on Chronic Neck Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01304368
Recruitment Status : Completed
First Posted : February 25, 2011
Last Update Posted : February 25, 2011
Sponsor:
Information provided by:
Universität Duisburg-Essen

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.


Condition or disease Intervention/treatment Phase
Neck Pain Procedure: Thermotherapy Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Official Title: Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
Study Start Date : August 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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.
 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.
No Intervention: Waiting list
Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Neck pain intensity (100mm visual analog scale) [ Time Frame: Day 14 ]
    100mm visual analog scale


Secondary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. Pain diary [ Time Frame: From day 1 to day 14 ]
    100mm visual analog scale for rating neck pain intensity each day

  5. 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.


  6. 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.


  7. 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.


  8. Side effects [ Time Frame: Day 14 ]
    Open question on any side effects or other experiences with the treatment

  9. Medication and additional treat ment use [ Time Frame: Day 14 ]
    Patient report used medication or additional treatment during the study period


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01304368


Locations
Layout table for location information
Germany
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, Northrhine-Westphalia, Germany, 45276
Sponsors and Collaborators
Universität Duisburg-Essen
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Gustav J Dobos, MD, Universität Duisburg-Essen, Chair of Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01304368    
Other Study ID Numbers: 09-3953
First Posted: February 25, 2011    Key Record Dates
Last Update Posted: February 25, 2011
Last Verified: February 2011
Keywords provided by Universität Duisburg-Essen:
Hyperthermia, Induced
Randomized Controlled Trial
Neck Pain
Sensory Thresholds
Pain Measurements
Additional relevant MeSH terms:
Layout table for MeSH terms
Neck Pain
Pain
Neurologic Manifestations