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Effects of Thermotherapy on Chronic Neck Pain

Primary Purpose

Neck Pain

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Thermotherapy
Sponsored by
Universität Duisburg-Essen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neck Pain focused on measuring Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Thermotherapy

Waiting list

Arm Description

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.

Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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.
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.
Pain diary
100mm visual analog scale for rating neck pain intensity each day
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.
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.
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.
Side effects
Open question on any side effects or other experiences with the treatment
Medication and additional treat ment use
Patient report used medication or additional treatment during the study period

Full Information

First Posted
February 24, 2011
Last Updated
February 24, 2011
Sponsor
Universität Duisburg-Essen
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1. Study Identification

Unique Protocol Identification Number
NCT01304368
Brief Title
Effects of Thermotherapy on Chronic Neck Pain
Official Title
Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
August 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Universität Duisburg-Essen

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neck Pain
Keywords
Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thermotherapy
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Waiting list
Arm Type
No Intervention
Arm Description
Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.
Intervention Type
Procedure
Intervention Name(s)
Thermotherapy
Intervention Description
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 Measure Information:
Title
Neck pain intensity (100mm visual analog scale)
Description
100mm visual analog scale
Time Frame
Day 14
Secondary Outcome Measure Information:
Title
Pain related to motion
Description
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.
Time Frame
Day 14
Title
Neck disability index (NDI)
Description
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.
Time Frame
Day 14
Title
SF-36
Description
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.
Time Frame
Day 14
Title
Pain diary
Description
100mm visual analog scale for rating neck pain intensity each day
Time Frame
From day 1 to day 14
Title
Pressure pain threshold
Description
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.
Time Frame
Day 14
Title
Vibration detection threshold
Description
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.
Time Frame
Day 14
Title
Mechanical detection threshold
Description
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.
Time Frame
Day 14
Title
Side effects
Description
Open question on any side effects or other experiences with the treatment
Time Frame
Day 14
Title
Medication and additional treat ment use
Description
Patient report used medication or additional treatment during the study period
Time Frame
Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
City
Essen
State/Province
Northrhine-Westphalia
ZIP/Postal Code
45276
Country
Germany

12. IPD Sharing Statement

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Effects of Thermotherapy on Chronic Neck Pain

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