Tuina for Patients With Chronic Neck Pain

NCT01923493 | Completed

• 1 other identifier: Tuina-13
• Study Type: interventional
• Target: 92
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Neck Pain

Keywords

neck pain; tuina

Outcome Measures

Primary Outcomes (1)

• mean neck pain intensity of the last seven days

  4 weeks

Secondary Outcomes (9)

• mean neck pain intensity of the last seven days

  12 weeks

• 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

Study Arms (2)

no intervention waiting list

ACTIVE COMPARATOR

Patients in the no intervention waiting list group will not receive a study intervention.

Other: no intervention

tuina

EXPERIMENTAL

tuina treatment

Other: tuina

Interventions

tuina OTHER

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.

Also known as: chinese massage

tuina

no intervention OTHER

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.

no intervention waiting list

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• female or male
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead

Study Sites (1)

Institute for Social Medicine, Epidemiology and Health Economics Charité Universitätsmedizin Berlin

Berlin, State of Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Neck Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Claudia M Witt, MD

  Institute for Social Medicine, Epidemiology and Health Economics, Charité - Universitätsmedizin Berlin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. med.

Study Record Dates

• First Submitted: August 13, 2013
• First Posted: August 15, 2013
• Study Start: August 1, 2013
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: February 9, 2015

Record last verified: 2015-02

Locations

DE (1)