Chronic Neck PaintuinaNCT01923493
Tuina for Patients With Chronic Neck Pain
A study testing tuina in people with Chronic Neck Pain, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Neck Pain
- What is being tested?
- tuina
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 92 participants
- Where
- 1 siteGermany
- Study dates
- Aug 2013to Jun 2014
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- female or male
- 18 to 60 years of age
- clinical diagnosis "chronic neck pain", i.e. neck pain for at least 12 weeks
- if additional back pain is reported, neck pain has to be predominant
- intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)
- ability to give oral and signed written informed consent
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- patient's mental and physical ability to participate in the trial
- willingness to be randomized, to attend visits, to complete questionnaires
- written and oral informed consent
Who cannot join
- neck pain caused by a malignant disease
- neck pain caused by trauma
- rheumatic disorder
- prior spinal column surgery
- neurological symptoms, e.g. radicular symptoms because of a prolapsed vertebral disc
- suspected osteoporosis
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- obesity with BMI ≥30 Kg/m2
- known vascular anomaly such as aneurysm
- regular intake of analgesics (>1x per week) because of a additional diseases
- intake of centrally acting analgesics
- current application for a benefit
- pregnancy
- severe acute and or chronic disease which does not allow participation in the therapy
- other limitations which do not allow participation in the therapy
- alcohol or substance abuse
- tuina treatment during the six months before study entry
- participation in another clinical trial during six months before the study and parallel to the study
- anticipated new treatments which have a positive influence on the neck pain such as physiotherapy against neck pain, acupuncture, massage during the study
- no sufficient German language skills
Trial locations and contacts
1 site in 1 country.
Germany1 site
Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Berlin, State of Berlin, 10117
About this study
Official title: Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
Read the detailed description
Objective: To evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
Study Design: Open single-centre randomized two-armed controlled trial. Setting: The study will be performed at a University out-patient clinic specialized in Integrative Medicine, with experience in the treatment of chronic pain.
Participants: 88 outpatients with chronic neck pain, who will be randomly allocated to two groups (tuina, or no intervention (control)).
Intervention: Patients receive either six tuina treatments within 3 weeks or no additional intervention.
Main outcome measure: The primary outcome is the mean neck pain intensity over the last seven days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst imaginable pain) after four weeks.
- Conditions
- Chronic Neck Pain
- Being tested
- tuina, no intervention
- Keywords
- neck pain, tuina
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tuinaOther
Also called chinese massage
Patients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied.
no interventionOther
Patients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period.
| Study group | Role | What they receive |
|---|---|---|
| no intervention waiting list | Active comparator | Patients in the no intervention waiting list group will not receive a study intervention. Receives: Other: no intervention |
| tuina | Experimental | tuina treatment Receives: Other: tuina |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean neck pain intensity of the last seven days
Measured: 4 weeks
Secondary outcomes (9)
mean neck pain intensity of the last seven days
Measured: 12 weeks
Neck Pain and Disability Scale (NPDS)
Measured: 4 weeks, 12 weeks
Neck Disability Index (NDI)
Measured: 4 weeks, 12 weeks
SF-12 health related quality of life
Measured: 4 weeks, 12 weeks
Costs
Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.
Measured: 4 weeks, 12 weeks
Body efficacy expectation
Body-Efficacy Expectation (BEE) is a scale to measure the conviction that one's body is able to deal with health-threatening factors by itself. It is a six items' scale developed in the Institute of Social Medicine, Epidemiology and Health Economics
Measured: 4 weeks, 12 weeks
medication intake
number and type of medication used
Measured: 4 weeks, 12 weeks
number of serious adverse events
Measured: 4 weeks, 12 weeks
adverse reactions
Measured: 4 weeks, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startAug 2013
- Primary completionApr 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Neck PainStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claudia M. Witt, Charite University, Berlin, Germany
- Investigators
- Claudia M Witt, MD, Principal investigator, Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923493
- Sponsor's protocol ID
- Tuina-13
- Acronym
- tuina
- Status last verified
- Feb 2015
- First submitted
- 13 Aug 2013
- Last updated
- 9 Feb 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
- ClinicalTrials.gov ID
- NCT01923493
- Acronym / sponsor ID
- tuina / Tuina-13
- Conditions
- Chronic Neck Pain
- Keywords
- neck pain, tuina
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 15 Aug 2013 (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.
The aim is to evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
Detailed description
Objective: To evaluate whether tuina is more effective and cost-effective than no intervention waiting list to reduce neck pain measured on a visual analogue scale in patients suffering from chronic neck pain.
Study Design: Open single-centre randomized two-armed controlled trial. Setting: The study will be performed at a University out-patient clinic specialized in Integrative Medicine, with experience in the treatment of chronic pain.
Participants: 88 outpatients with chronic neck pain, who will be randomly allocated to two groups (tuina, or no intervention (control)).
Intervention: Patients receive either six tuina treatments within 3 weeks or no additional intervention.
Main outcome measure: The primary outcome is the mean neck pain intensity over the last seven days on a visual analogue scale (Huskisson, 1974) (VAS, 0-100 mm, 0 = no pain, 100= worst imaginable pain) after four weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| no intervention waiting list | Active comparator | Other: no interventionPatients in the no intervention waiting list group will not receive a study intervention. |
| tuina | Experimental | Other: tuinatuina treatment |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- female or male
- 18 to 60 years of age
- clinical diagnosis "chronic neck pain", i.e. neck pain for at least 12 weeks
- if additional back pain is reported, neck pain has to be predominant
- intensity of the average neck pain over the last 7 days had to be more than 40 mm on a 100-mm visual analogue scale (VAS)
Key exclusion criteria (19 listed)
- neck pain caused by a malignant disease
- neck pain caused by trauma
- rheumatic disorder
- prior spinal column surgery
- neurological symptoms, e.g. radicular symptoms because of a prolapsed vertebral disc
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 |
|---|---|---|
| tuinaAlso: chinese massagePatients in the tuina group will receive a tuina therapy (also known as Chinese massage). A Chinese massage lasts about 20 to 30 minutes. A series of 6 sessions with 2 treatments per week is applied. | Other | tuina |
| no interventionPatients in the no intervention waiting list group will not receive a study intervention. They will continue their respective pre-study therapy during the study period. | Other | no intervention waiting list |
Primary outcome
mean neck pain intensity of the last seven days
Time frame: 4 weeks
9 secondary outcomes
mean neck pain intensity of the last seven days
Time frame: 12 weeks
Neck Pain and Disability Scale (NPDS)
Time frame: 4 weeks, 12 weeks
Neck Disability Index (NDI)
Time frame: 4 weeks, 12 weeks
SF-12 health related quality of life
Time frame: 4 weeks, 12 weeks
Costs
Time frame: 4 weeks, 12 weeks
Body efficacy expectation
Time frame: 4 weeks, 12 weeks
medication intake
Time frame: 4 weeks, 12 weeks
number of serious adverse events
Time frame: 4 weeks, 12 weeks
adverse reactions
Time frame: 4 weeks, 12 weeks
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 9 Feb 2015.
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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.
Claudia M Witt, MD principal investigator
Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tuina in people with Chronic Neck Pain, run by Charite University, Berlin, Germany 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 9 inclusion and 19 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 9 Feb 2015. 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?
mean neck pain intensity of the last seven days (time frame: 4 weeks). 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 9 Feb 2015.