Athletic InjuriesNCT02725697
Treatment of Complaints Following Sports Injuries With Traditional Chinese Medicine
An observational study of Athletic Injuries, run by Sabine Klein at 3 sites in Switzerland.
Trial summary
The purpose of this observational study is to investigate the treatment of complaints following sports injuries with Traditional Chinese Medicine by therapists in Switzerland. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Athletic Injuries
- What is being tested?
- TCM treatment
- How many people
- 2 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Apr 2016to Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients seeking TCM treatment due to complaints following sports injuries.
Who may be able to join
- 18 years or older
- minimum of 3 hours sports per week
- complaints following sports injury
- first TCM treatment for this complaint
Who cannot join
- rheumatic disease
- arthrosis
- previous TCM treatment for this complaint
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Poliklinik für Chinesische Medizin
Horgen, Canton of Zurich, 8810
Praxis für TCM
Zurich, Canton of Zurich, 8004
proSANUS
Zurich, Canton of Zurich, 8008
About this study
Official title: 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.
Read the 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.
- Conditions
- Athletic Injuries
- Being tested
- TCM treatment
- Medical subject headings
- Athletic Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TCM treatmentOther
| Study group | Role | What they receive |
|---|---|---|
| TCM treatment | TCM treatment (e.g. acupuncture, Tuina massage, Chinese herbal medicine, moxibustion, electroacupuncture, ear acupuncture) Receives: Other: TCM treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in minimal and maximal pain
visual analogue scale (0-10)
Measured: first treatment, last treatment (max. 3 months)
change in limitation during sports
visual analogue scale (0-10)
Measured: first treatment, last treatment (max. 3 months)
Secondary outcomes (4)
medication intake
Measured: first treatment, last treatment (max. 3 months)
patient satisfaction with therapy
6 point Likert scale
Measured: 6 months
number of therapeutic sessions
Measured: 3 months
TCM methods applied
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startApr 2016
- Primary completionJun 2018
- Study completionJun 2018
Why it stopped: too few participans available
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Athletic InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sabine Klein
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sabine Klein, Swiss Professional Organization for Traditional Chinese Medicine
- Investigators
- Sabine D Klein, PhD, Principal investigator, Swiss Professional Organization for Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725697
- Sponsor's protocol ID
- SBO-TCM 001
- Status last verified
- Sep 2018
- First submitted
- 20 Mar 2016
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Klein SD, Frei-Erb M, Wolf U. Usage of complementary medicine across Switzerland: results of the Swiss Health Survey 2007. Swiss Med Wkly. 2012 Aug 15;142:w13666. doi: 10.4414/smw.2012.13666. eCollection 2012.
PubMed 22895817Michlig M, Ausfeld-Hafter B, Busato A. Patient satisfaction with primary care: a comparison between conventional care and traditional Chinese medicine. Complement Ther Med. 2008 Dec;16(6):350-8. doi: 10.1016/j.ctim.2007.12.001. Epub 2008 Feb 4.
PubMed 19028336Lin ZP, Chen YH, Chia F, Wu HJ, Lan LW, Lin JG. Episodes of injuries and frequent usage of traditional Chinese medicine for Taiwanese elite wrestling athletes. Am J Chin Med. 2011;39(2):233-41. doi: 10.1142/S0192415X11008774.
PubMed 21476201Malone MA, Gloyer K. Complementary and alternative treatments in sports medicine. Prim Care. 2013 Dec;40(4):945-68, ix. doi: 10.1016/j.pop.2013.08.010. Epub 2013 Sep 26.
PubMed 24209727Park J, Hahn S, Park JY, Park HJ, Lee H. Acupuncture for ankle sprain: systematic review and meta-analysis. BMC Complement Altern Med. 2013 Mar 4;13:55. doi: 10.1186/1472-6882-13-55.
PubMed 23496981
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute and Chronic Complaints Following Sports Injuries With Traditional Chinese Medicine (TCM) by Therapists in Switzerland - a Prospective Observational Study
- ClinicalTrials.gov ID
- NCT02725697
- Acronym / sponsor ID
- SBO-TCM 001
- Conditions
- Athletic Injuries
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: too few participans available
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Sabine KleinUniversity, hospital or other
- Study start
- Apr 2016
- Primary completion
- Jun 2018 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this observational study is to investigate the treatment of complaints following sports injuries with Traditional Chinese Medicine by therapists in Switzerland.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TCM treatment | – | Other: TCM treatmentTCM treatment (e.g. acupuncture, Tuina massage, Chinese herbal medicine, moxibustion, electroacupuncture, ear acupuncture) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients seeking TCM treatment due to complaints following sports injuries.
Key inclusion criteria (4 listed)
- 18 years or older
- minimum of 3 hours sports per week
- complaints following sports injury
- first TCM treatment for this complaint
Key exclusion criteria (3 listed)
- rheumatic disease
- arthrosis
- previous TCM treatment for this complaint
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TCM treatment | Other | TCM treatment |
Primary outcome
change in minimal and maximal pain
Time frame: first treatment, last treatment (max. 3 months)
visual analogue scale (0-10)
change in limitation during sports
Time frame: first treatment, last treatment (max. 3 months)
visual analogue scale (0-10)
4 secondary outcomes
medication intake
Time frame: first treatment, last treatment (max. 3 months)
patient satisfaction with therapy
Time frame: 6 months
number of therapeutic sessions
Time frame: 3 months
TCM methods applied
Time frame: 3 months
Results and safety
The study was stopped early (reason given: too few participans available). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2018.
- Background: PubMed 22895817Klein SD, Frei-Erb M, Wolf U. Usage of complementary medicine across Switzerland: results of the Swiss Health Survey 2007. Swiss Med Wkly. 2012 Aug 15;142:w13666. doi: 10.4414/smw.2012.13666. eCollection 2012.
- Background: PubMed 19028336Michlig M, Ausfeld-Hafter B, Busato A. Patient satisfaction with primary care: a comparison between conventional care and traditional Chinese medicine. Complement Ther Med. 2008 Dec;16(6):350-8. doi: 10.1016/j.ctim.2007.12.001. Epub 2008 Feb 4.
- Background: PubMed 21476201Lin ZP, Chen YH, Chia F, Wu HJ, Lan LW, Lin JG. Episodes of injuries and frequent usage of traditional Chinese medicine for Taiwanese elite wrestling athletes. Am J Chin Med. 2011;39(2):233-41. doi: 10.1142/S0192415X11008774.
- Background: PubMed 24209727Malone MA, Gloyer K. Complementary and alternative treatments in sports medicine. Prim Care. 2013 Dec;40(4):945-68, ix. doi: 10.1016/j.pop.2013.08.010. Epub 2013 Sep 26.
- Background: PubMed 23496981Park J, Hahn S, Park JY, Park HJ, Lee H. Acupuncture for ankle sprain: systematic review and meta-analysis. BMC Complement Altern Med. 2013 Mar 4;13:55. doi: 10.1186/1472-6882-13-55.
- Website of Swiss Professional Organization for Traditional Chinese MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sabine D Klein, PhD principal investigator
Swiss Professional Organization for Traditional Chinese Medicine
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Athletic Injuries, run by Sabine Klein at 3 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 6 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: too few participans available). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in minimal and maximal pain (time frame: first treatment, last treatment (max. 3 months)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02725697, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2018.