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.

Study Overview

• Status: Completed
• Conditions: Neck Pain
• Intervention / Treatment: Procedure: Thermotherapy

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Northrhine-Westphalia
    • Essen, Northrhine-Westphalia, Germany, 45276
      • Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Neck pain intensity (100mm visual analog scale)	100mm visual analog scale	Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
Pain diary	100mm visual analog scale for rating neck pain intensity each day	From day 1 to day 14
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
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
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
Side effects	Open question on any side effects or other experiences with the treatment	Day 14
Medication and additional treat ment use	Patient report used medication or additional treatment during the study period	Day 14

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (ACTUAL): August 1, 2010
• Study Completion (ACTUAL): August 1, 2010

Study Registration Dates

• First Submitted: February 24, 2011
• First Submitted That Met QC Criteria: February 24, 2011
• First Posted (ESTIMATE): February 25, 2011

Study Record Updates

• Last Update Posted (ESTIMATE): February 25, 2011
• Last Update Submitted That Met QC Criteria: February 24, 2011
• Last Verified: February 1, 2011

More Information

Terms related to this study

• Keywords: Randomized Controlled Trial; Neck Pain; Sensory Thresholds; Pain Measurements; Hyperthermia, Induced
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Neck Pain
• Other Study ID Numbers: 09-3953