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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
  Purpose

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 Intervention
Neck Pain
 Procedure: Thermotherapy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Universität Duisburg-Essen:

Primary Outcome Measures:
  • Neck pain intensity (100mm visual analog scale) [ Time Frame: Day 14 ] [ Designated as safety issue: No ]
    100mm visual analog scale


Secondary Outcome Measures:
  • 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


Enrollment: 50
Study Start Date: August 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01304368

Locations
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

No publications provided

Responsible Party: Gustav J Dobos, MD, Universität Duisburg-Essen, Chair of Complementary and Integrative Medicine
ClinicalTrials.gov Identifier: NCT01304368     History of Changes
Other Study ID Numbers: 09-3953
Study First Received: February 24, 2011
Last Updated: February 24, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by Universität Duisburg-Essen:
Hyperthermia, Induced
Randomized Controlled Trial
Neck Pain
Sensory Thresholds
Pain Measurements

Additional relevant MeSH terms:
Neck Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Analgesics
 Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013