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Completed

NCT Number: NCT01304368

Effects of Thermotherapy on 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.

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Key information

Conditions

Neck Pain Body Temperature Changes Heat Stress Disorders Hyperthermia Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine

Essen, North Rhine-Westphalia, 45276, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Thermotherapy

Procedure

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.

Primary outcomes

  1. Neck pain intensity (100mm visual analog scale)

    Time frame: Day 14

    100mm visual analog scale

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Feb 25, 2011
Registry last updated
Feb 25, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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