Neck PainNCT01304368
Effects of Thermotherapy on Chronic Neck Pain
A study testing Thermotherapy in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neck Pain
- What is being tested?
- Thermotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2009to Aug 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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"
Who cannot join
- radicular symptoms
- congenital spine deformity
- skin diseases in the painful area to be treated
- pregnancy
- insulin-dependent diabetes mellitus
- rheumatic diseases
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- oncologic diseases
- steroid medication
- anticoagulation medication
- recent invasive or surgical treatment of the spine
Trial locations and contacts
1 site in 1 country.
Germany1 site
Kliniken Essen-Mitte, Knappschafts-Krankenhaus, Department for Internal and Integrative Medicine
Essen, North Rhine-Westphalia, 45276
About this study
Official title: 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.
- Conditions
- Neck Pain
- Being tested
- Thermotherapy
- Keywords
- Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements
- Medical subject headings
- Neck Pain, Hyperthermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThermotherapyProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| Thermotherapy | Active comparator | 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. Receives: Procedure: Thermotherapy |
| Waiting list | No intervention | Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neck pain intensity (100mm visual analog scale)
100mm visual analog scale
Measured: Day 14
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: Day 14
Pain diary
100mm visual analog scale for rating neck pain intensity each day
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 14
Side effects
Open question on any side effects or other experiences with the treatment
Measured: Day 14
Medication and additional treat ment use
Patient report used medication or additional treatment during the study period
Measured: Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2011 (estimated)
- Study startAug 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neck PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01304368
- Sponsor's protocol ID
- 09-3953
- Status last verified
- Feb 2011
- First submitted
- 24 Feb 2011
- Last updated
- 25 Feb 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Pilot Study: Effects of a Heat Pad Application in Patients With Chronic Neck Pain
- ClinicalTrials.gov ID
- NCT01304368
- Acronym / sponsor ID
- 09-3953
- Conditions
- Neck Pain
- Keywords
- Hyperthermia, Induced, Randomized Controlled Trial, Neck Pain, Sensory Thresholds, Pain Measurements
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 25 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thermotherapy | Active comparator | Procedure: ThermotherapyPatients 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 intervention | –Patients are instructed to continue their usual medication - including analgesic drugs - and physiotherapy (massages and exercise) during the study period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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"
Key exclusion criteria (10 listed)
- radicular symptoms
- congenital spine deformity
- skin diseases in the painful area to be treated
- pregnancy
- insulin-dependent diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ThermotherapyPatients 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 or surgery | Thermotherapy |
Primary outcome
Neck pain intensity (100mm visual analog scale)
Time frame: Day 14
100mm visual analog scale
9 secondary outcomes
Pain related to motion
Time frame: Day 14
Neck disability index (NDI)
Time frame: Day 14
SF-36
Time frame: Day 14
Pain diary
Time frame: From day 1 to day 14
Pressure pain threshold
Time frame: Day 14
Vibration detection threshold
Time frame: Day 14
Mechanical detection threshold
Time frame: Day 14
Side effects
Time frame: Day 14
Medication and additional treat ment use
Time frame: Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thermotherapy in people with Neck Pain, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Feb 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain intensity (100mm visual analog scale) (time frame: Day 14). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Feb 2011.