Treatment of Complaints Following Sports Injuries With Traditional Chinese Medicine

September 4, 2018 updated by: Sabine Klein

Treatment of Acute and Chronic Complaints Following Sports Injuries With Traditional Chinese Medicine (TCM) by Therapists in Switzerland - a Prospective Observational Study

The purpose of this observational study is to investigate the treatment of complaints following sports injuries with Traditional Chinese Medicine by therapists in Switzerland.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

In Switzerland, still very little is known about the treatment with TCM (acupuncture, Chinese medicinal therapy, Tuina massage, nutrition, qigong) under everyday conditions. The importance of non-medical therapists in the healthcare system is rarely investigated. It is likely that patients with chronic injuries use several therapies (including conventional medicine) in a pragmatic way. They may apply TCM either due to primary preference or because other forms of therapy fail to produce satisfactory results.

There is evidence from randomized controlled trials and systematic reviews that acupuncture can be effective in the treatment of acute and chronic back pain, chronic shoulder pain and ankle sprains.

Randomized controlled trials usually investigate a single TCM method, in which therapists or physicians are limited in the selection of acupuncture points or herbal formulas. This does not reflect the complex practice, where several TCM methods and auxiliary techniques are combined.

The investigators aim to investigate in a prospective observational study how complaints following sports injuries are treated by non-medical TCM therapists in Switzerland under everyday conditions.

Study Type

Observational

Enrollment (Actual)

2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
    • ZH
      • Horgen, ZH, Switzerland, 8810
        • Poliklinik für Chinesische Medizin
      • Zürich, ZH, Switzerland, 8004
        • Praxis für TCM
      • Zürich, ZH, Switzerland, 8008
        • proSANUS

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seeking TCM treatment due to complaints following sports injuries.

Description

Inclusion Criteria:

  • 18 years or older
  • minimum of 3 hours sports per week
  • complaints following sports injury
  • first TCM treatment for this complaint

Exclusion Criteria:

  • rheumatic disease
  • arthrosis
  • previous TCM treatment for this complaint

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
TCM treatment
TCM treatment (e.g. acupuncture, Tuina massage, Chinese herbal medicine, moxibustion, electroacupuncture, ear acupuncture)
Other: TCM treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in minimal and maximal pain
Time Frame: first treatment, last treatment (max. 3 months)
visual analogue scale (0-10)
first treatment, last treatment (max. 3 months)
change in limitation during sports
Time Frame: first treatment, last treatment (max. 3 months)
visual analogue scale (0-10)
first treatment, last treatment (max. 3 months)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
medication intake
Time Frame: first treatment, last treatment (max. 3 months)
first treatment, last treatment (max. 3 months)
patient satisfaction with therapy
Time Frame: 6 months
6 point Likert scale
6 months
number of therapeutic sessions
Time Frame: 3 months
3 months
TCM methods applied
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sabine Klein

Investigators

  • Principal Investigator: Sabine D Klein, PhD, Swiss Professional Organization for Traditional Chinese Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2016

Primary Completion (ACTUAL)

June 1, 2018

Study Completion (ACTUAL)

June 1, 2018

Study Registration Dates

First Submitted

March 20, 2016

First Submitted That Met QC Criteria

March 28, 2016

First Posted (ESTIMATE)

April 1, 2016

Study Record Updates

Last Update Posted (ACTUAL)

September 6, 2018

Last Update Submitted That Met QC Criteria

September 4, 2018

Last Verified

September 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SBO-TCM 001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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