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Effects of Thermotherapy on Chronic Neck Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01304368
Enrollment
50
Registered
2011-02-25
Start date
2009-08-31
Completion date
2010-08-31
Last updated
2011-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neck Pain

Keywords

Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements

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.

Interventions

PROCEDUREThermotherapy

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.

Sponsors

Universität Duisburg-Essen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Neck pain intensity (100mm visual analog scale)Day 14100mm visual analog scale

Secondary

MeasureTime frameDescription
Neck disability index (NDI)Day 14The 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-36Day 14The 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 diaryFrom day 1 to day 14100mm visual analog scale for rating neck pain intensity each day
Pressure pain thresholdDay 14Pressure 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.
Pain related to motionDay 14100mm 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.
Mechanical detection thresholdDay 14Mechanical 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 effectsDay 14Open question on any side effects or other experiences with the treatment
Medication and additional treat ment useDay 14Patient report used medication or additional treatment during the study period
Vibration detection thresholdDay 14Vibration 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.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026