Effects of Thermotherapy on Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01304368
• Other study ID #: 09-3953
• Status: Completed
• Phase: N/A
• First received: February 24, 2011
• Last updated: February 24, 2011
• Start date: August 2009
• Est. completion date: August 2010

Study information

• Verified date: February 2011
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Neck Pain

Intervention

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.

Locations

Country	Name	City	State
Germany	Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine	Essen	Northrhine-Westphalia

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neck pain intensity (100mm visual analog scale)	100mm visual analog scale	Day 14	No
Secondary	Pain related to motion	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.	Day 14	No
Secondary	Neck disability index (NDI)	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.	Day 14	No
Secondary	SF-36	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.	Day 14	No
Secondary	Pain diary	100mm visual analog scale for rating neck pain intensity each day	From day 1 to day 14	No
Secondary	Pressure pain threshold	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.	Day 14	No
Secondary	Vibration detection threshold	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.	Day 14	No
Secondary	Mechanical detection threshold	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.	Day 14	No
Secondary	Side effects	Open question on any side effects or other experiences with the treatment	Day 14	Yes
Secondary	Medication and additional treat ment use	Patient report used medication or additional treatment during the study period	Day 14	No