Clinical trial NCT00615732: Qigong and Exercise for Neck Pain in Adults (QENA)
Official title: Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Neck Pain
Keywords: qigong
traditional chinese medicine
exercise therapy
neck pain
Lead sponsor: Charite University, Berlin, Germany
Sponsor class: OTHER
First posted: 2008-02-14
Enrollment: 123
Sex: ALL
Minimum age (years): 20
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess the effectiveness of qigong for the treatment of chronic neck pain compared to exercise therapy and waiting list group.


Eligibility criteria: Inclusion Criteria:

* clinical diagnosis of chronic neck pain since at least 6 months and complaints for a maximum duration of 5 years
* neck pain more prominent than other pain in the spine
* average pain intensity of the last 7 days more or equal to 40 mm measured by a visual analogue scale (VAS 0 - 100 mm)
* normal mobility of the cervical spine
* intellectual and physical ability to participate in the study
* informed consent

Exclusion Criteria:

* cervical pain related to malignancy
* cervical pain due to an accident
* inflammatory joint disorders
* previous spine surgery
* protrusion/prolapse of a spinal disk, spondylolisthesis, with radicular symptomatology
* actually doing or planning to do other regular physical exercise during the study with possible positive effects on neck pain - such as swimming, yoga, pilates, tai chi, etc.
* use of pain drugs for other diseases (\> 1x/week)
* pregnancy
* severe chronic or acute disease interfering with therapy attendance
* alcohol or substance abuse
* participation in another clinical trial in the last 6 months before study entry

Primary outcomes:
measure: average pain intensity during the last 7 days measured on a visual analogue scale (VAS)
timeFrame: baseline, 3, 6, 12, and 24 months
Secondary outcomes:
measure: Neck Pain and Disability Scale (NPAD, Wheeler 1999)
timeFrame: baseline, 3, 6, 12, and 24 months
measure: health related quality of life (SF-36)
timeFrame: baseline, 3, 6, 12 and 24 months
measure: patient expectation and self efficacy (questionnaire)
timeFrame: Baseline, 3, 6, 12, and 24 months
measure: therapist's expectation
timeFrame: baseline, 3, 6, 12, and 24 months
measure: undesired effects
timeFrame: 3, 6, 12, and 24 months
measure: semi-structured interviews to detect changes due to therapy and to assess the used questionnaires
timeFrame: 3 and 6 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center
Study officials:
affiliation: Charite University, Berlin, Germany
name: Claudia M Witt, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rendant D, Pach D, Ludtke R, Reisshauer A, Mietzner A, Willich SN, Witt CM. Qigong versus exercise versus no therapy for patients with chronic neck pain: a randomized controlled trial. Spine (Phila Pa 1976). 2011 Mar 15;36(6):419-27. doi: 10.1097/BRS.0b013e3181d51fca.