Chronic Neck Pain
Conditions
Keywords
neck pain, tuina
Brief 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.
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.
Interventions
OTHERtuina
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.
OTHERno intervention
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.
Sponsors
Charite University, Berlin, Germany
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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 * 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| mean neck pain intensity of the last seven days | 4 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Neck Pain and Disability Scale (NPDS) | 4 weeks, 12 weeks | — |
| Neck Disability Index (NDI) | 4 weeks, 12 weeks | — |
| SF-12 health related quality of life | 4 weeks, 12 weeks | — |
| Costs | 4 weeks, 12 weeks | Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires. |
| mean neck pain intensity of the last seven days | 12 weeks | — |
| medication intake | 4 weeks, 12 weeks | number and type of medication used |
| number of serious adverse events | 4 weeks, 12 weeks | — |
| adverse reactions | 4 weeks, 12 weeks | — |
| Body efficacy expectation | 4 weeks, 12 weeks | 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 |
Countries
Germany
Outcome results
None listed