Skip to main content
OpenTrials
Completed

NCT Number: NCT01923493

Tuina for Patients With Chronic Neck Pain

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Berlin, State of Berlin, 10117, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: chinese massage

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.

Primary outcomes

  1. mean neck pain intensity of the last seven days

    Time frame: 4 weeks

Secondary outcomes

  1. mean neck pain intensity of the last seven days

    Time frame: 12 weeks

  2. Neck Pain and Disability Scale (NPDS)

    Time frame: 4 weeks, 12 weeks

  3. Neck Disability Index (NDI)

    Time frame: 4 weeks, 12 weeks

  4. SF-12 health related quality of life

    Time frame: 4 weeks, 12 weeks

  5. Costs

    Time frame: 4 weeks, 12 weeks

    Data on Resource-consumption and associated costs are planned to be derived as patient-reported information using the patient questionnaires.

  6. Body efficacy expectation

    Time frame: 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

  7. medication intake

    Time frame: 4 weeks, 12 weeks

    number and type of medication used

  8. number of serious adverse events

    Time frame: 4 weeks, 12 weeks

  9. adverse reactions

    Time frame: 4 weeks, 12 weeks

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Registry information

Official study title

Chronic Neck Pain: a Randomized Controlled Trial in Patients With Chronic Neck Pain Comparing Tuina vs. no Intervention Waiting List

Acronym: tuina

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Aug 15, 2013
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.