Effects of Thermotherapy on Chronic Neck Pain

Study Overview
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Brief Summary
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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.

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

Conditions
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Neck Pain

Intervention / Treatment
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* Procedure: Thermotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Thermotherapy<br>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<br>* 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.<br>|
| No Intervention: Waiting list<br>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?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements