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

February 24, 2011
February 24, 2011
August 2009
August 2010   (final data collection date for primary outcome measure)
Neck pain intensity (100mm visual analog scale) [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
100mm visual analog scale
Same as current
No Changes Posted
  • 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
Same as current
Not Provided
Not Provided
 
Effects of Thermotherapy on Chronic Neck Pain
Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
Neck Pain
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.
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
50
August 2010
August 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT01304368
09-3953
No
Gustav J Dobos, MD, Universität Duisburg-Essen, Chair of Complementary and Integrative Medicine
Universität Duisburg-Essen
Not Provided
Not Provided
Universität Duisburg-Essen
February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP