Effects of Thermotherapy on Chronic Neck Pain
Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Aug 2009
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
February 24, 2011
CompletedFirst Posted
Study publicly available on registry
February 25, 2011
CompletedFebruary 25, 2011
February 1, 2011
1 year
February 24, 2011
February 24, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Neck pain intensity (100mm visual analog scale)
100mm visual analog scale
Day 14
Secondary Outcomes (9)
Pain related to motion
Day 14
Neck disability index (NDI)
Day 14
SF-36
Day 14
Pain diary
From day 1 to day 14
Pressure pain threshold
Day 14
- +4 more secondary outcomes
Study Arms (2)
Thermotherapy
ACTIVE COMPARATORPatients 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.
Waiting list
NO INTERVENTIONPatients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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"
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 24, 2011
First Posted
February 25, 2011
Study Start
August 1, 2009
Primary Completion
August 1, 2010
Study Completion
August 1, 2010
Last Updated
February 25, 2011
Record last verified: 2011-02