Effects of Thermotherapy on Chronic Neck Pain

Not Applicable

Completed

• Conditions: Neck Pain
• Interventions: Procedure: Thermotherapy

• Registration Number: NCT01304368
• Lead Sponsor: Universität Duisburg-Essen

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 available

Study Timeline

• Study Start: 2009-08
• Primary Completion: 2010-08
• Study Completion: 2010-08
• Status Verified: 2011-02
• Study First Submitted: 2011-02-24
• Study First Submitted QC: 2011-02-24
• Last Update Submitted: 2011-02-24
• Study First Posted: 2011-02-25
• Last Update Posted: 2011-02-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Thermotherapy	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.

Primary Outcome Measures

Name	Time	Method
Neck pain intensity (100mm visual analog scale)	Day 14	100mm visual analog scale

Secondary Outcome Measures

Name	Time	Method
Pain related to motion	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)	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	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	From day 1 to day 14	100mm visual analog scale for rating neck pain intensity each day
Pressure pain threshold	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	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	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	Day 14	Open question on any side effects or other experiences with the treatment
Medication and additional treat ment use	Day 14	Patient report used medication or additional treatment during the study period

Trial Locations

Locations (1)

Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine; 🇩🇪 Essen, Northrhine-Westphalia, Germany