Clinical trial NCT01923493: Tuina for Patients With Chronic Neck Pain
Official title: Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: neck pain
tuina
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2013-08-15
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: mean neck pain intensity of the last seven days
timeFrame: 4 weeks
Secondary outcomes:
measure: mean neck pain intensity of the last seven days
timeFrame: 12 weeks
measure: Neck Pain and Disability Scale (NPDS)
timeFrame: 4 weeks, 12 weeks
measure: Neck Disability Index (NDI)
timeFrame: 4 weeks, 12 weeks
measure: SF-12 health related quality of life
timeFrame: 4 weeks, 12 weeks
measure: Costs
timeFrame: 4 weeks, 12 weeks
measure: Body efficacy expectation
timeFrame: 4 weeks, 12 weeks
measure: medication intake
timeFrame: 4 weeks, 12 weeks
measure: number of serious adverse events
timeFrame: 4 weeks, 12 weeks
measure: adverse reactions
timeFrame: 4 weeks, 12 weeks
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin
Study officials:
affiliation: Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References: