Qigong and Exercise for Neck Pain in Adults (QENA)

Chronic Neck Pain Clinical Trial

— QENA  

Official title:

Prospective, Randomized Controlled Trial on the Effectiveness of Qigong and Exercise Therapy in Patients With Chronic Neck Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00615732
• Other study ID #: QENA-08
• Status: Completed
• Phase: N/A
• First received: February 1, 2008
• Last updated: July 9, 2012
• Start date: March 2008
• Est. completion date: October 2009

Study information

• Verified date: July 2012
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 123
• Est. completion date: October 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Neck Pain
• Neck Pain

Intervention

Procedure:
• Qigong
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week
• exercise therapy
18 therapy sessions, during the first 3 months once a week, month 4 to 6 once every second week

Locations

Country	Name	City	State
Germany	Institute for Social Medicine, Epidemiology, and Health Economics, Charité University Medical Center	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

References & Publications (1)

Rendant D, Pach D, Lüdtke 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.0b01 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	average pain intensity during the last 7 days measured on a visual analogue scale (VAS)		baseline, 3, 6, 12, and 24 months	No
Secondary	Neck Pain and Disability Scale (NPAD, Wheeler 1999)		baseline, 3, 6, 12, and 24 months	No
Secondary	health related quality of life (SF-36)		baseline, 3, 6, 12 and 24 months	No
Secondary	patient expectation and self efficacy (questionnaire)		Baseline, 3, 6, 12, and 24 months	No
Secondary	therapist's expectation		baseline, 3, 6, 12, and 24 months	No
Secondary	undesired effects		3, 6, 12, and 24 months	Yes
Secondary	semi-structured interviews to detect changes due to therapy and to assess the used questionnaires		3 and 6 months	Yes