Trial · NCT01702233

TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study

NCT01702233, Phase 3, Completed, Biologische Heilmittel Heel GmbH; results first posted 2016-02-24

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study. Trials, record NCT01702233. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01702233

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: TRARO (Traumeel® S in Rotator Cuff Syndrome)-Study
NCT number: NCT01702233
Status: Completed
Phases: Phase 3
Enrollment: 175 participants, actual
Lead sponsor: Biologische Heilmittel Heel GmbH
Conditions: Rotator Cuff Syndrome, Shoulder Bursitis
Interventions: Traumeel S inj, Fortecortin/Dexamethasone 8 mg/2 ml inj, Saline inj
First posted: 2012-10-08
Last updated: 2016-02-24
Other registries' IDs: eudract:2012-003393-12
Results first posted: 2016-02-24

Source ClinicalTrials.gov

Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation	Baseline to Day 22	VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain). Change = (Day 22 score -- baseline score).
Secondary	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)	Baseline vs. Day 22	VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).
Secondary	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)	Baseline vs. Day 105	VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).
Secondary	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)	Baseline vs. day 105	VAS is a 100 mm visual analogue scale for measuring the pain resulted from the adbuction and external rotation of the arm. Possible scores range from 0 (no pain) to 100 (worst possible pain).
Secondary	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo	Baseline vs. Day 22	Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.
Secondary	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo	Baseline vs. day 105	Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.
Secondary	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin	Baseline vs. Day 22	Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.
Secondary	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin	Baseline vs. Day 105	Range of movement (ROM) changes measured by active external rotation in abduction in degrees by goniometry in the range of 0 to 360 degrees.
Secondary	Jobe Test at Visit 5 (Day 15) With Measurement of Pain	Baseline vs. Day 22	This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness.
Secondary	Jobe Test at Visit 5 (Day 22) With Measurement of Weakness	Baseline vs. day 22	This test looked for pain and weakness and was to be examined as active movement. Patients have to stand with shoulders in 90 degrees of abduction, 30 degrees of forward flexion and then internally rotating arm completely i.e., thumb pointing down. This was done to see if the patient was able to resist the clinician's attempts to depress the upper arm to look for muscle weakness.

1 to 10 of 13Source ClinicalTrials.gov

See all 13 registered outcomes

Outcomes13

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation	Baseline to Day 22	Per protocol population	units on a scale (mm)	MEAN
SECONDARY	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)	Baseline vs. Day 22		Change in mm baseline vs. day 22	MEAN
SECONDARY	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)	Baseline vs. Day 105		units on a scale, mm	MEAN
SECONDARY	Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)	Baseline vs. day 105		units on a scale, mm	MEAN
SECONDARY	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo	Baseline vs. Day 22		degrees	MEAN
SECONDARY	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Placebo	Baseline vs. day 105		degrees	MEAN
SECONDARY	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22) Traumeel vs Fortecortin	Baseline vs. Day 22		degrees	MEAN
SECONDARY	Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 7 (Day 105), Traumeel vs Fortecortin	Baseline vs. Day 105		degrees	MEAN
SECONDARY	Jobe Test at Visit 5 (Day 15) With Measurement of Pain	Baseline vs. Day 22		participants	NUMBER
SECONDARY	Jobe Test at Visit 5 (Day 22) With Measurement of Weakness	Baseline vs. day 22		participants	NUMBER

1 to 10 of 13Source ClinicalTrials.gov

See all 13 outcomes

Results by group31

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation	Traumeel S Inj.	-18.7	Standard Deviation 21.49	units on a scale (mm)
Change From Baseline in Abduction Rotation Pain VAS at Visit 5 (Day 22) (Traumeel® S Injections Versus Fortecortin) for Active External Rotation	Fortecortin/Dexamethasone 8 mg Inj	-27.2	Standard Deviation 23.44	units on a scale (mm)
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)	Traumeel S Inj.	-18.7	Standard Deviation 21.49	Change in mm baseline vs. day 22
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 5 (Day 22)	Saline Inj	-17.1	Standard Deviation 23.94	Change in mm baseline vs. day 22
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)	Traumeel S Inj.	-32.2	Standard Deviation 26.59	units on a scale, mm
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Placebo Visit 7 (Day 105)	Saline Inj	-30.1	Standard Deviation 27.80	units on a scale, mm
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)	Traumeel S Inj.	-32.2	Standard Deviation 26.59	units on a scale, mm
Change From Baseline in Abduction Rotation Pain VAS for Active External Rotation - Comparison With Fortecortin at Visit 7 (Day 105)	Fortecortin/Dexamethasone 8 mg Inj	-33.3	Standard Deviation 28.35	units on a scale, mm
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo	Traumeel S Inj.	11.3	Standard Deviation 15.73	degrees
Changes From Baseline in ROM in Degrees (Active External Rotation in Abduction) After Visit 5 (Day 22), Traumeel vs Placebo	Saline Inj	13.5	Standard Deviation 18.65	degrees

1 to 10 of 31Source ClinicalTrials.gov

See all 31 results by group

Participant flow15

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Traumeel S Inj.	72
Overall Study	STARTED	Fortecortin/Dexamethasone 8 mg Inj	67
Overall Study	STARTED	Saline Inj.	36
Overall Study	Full Analysis Set (ITT)	Traumeel S Inj.	66
Overall Study	Full Analysis Set (ITT)	Fortecortin/Dexamethasone 8 mg Inj	63
Overall Study	Full Analysis Set (ITT)	Saline Inj.	31
Overall Study	Per Protocol Set	Traumeel S Inj.	58
Overall Study	Per Protocol Set	Fortecortin/Dexamethasone 8 mg Inj	58
Overall Study	Per Protocol Set	Saline Inj.	27
Overall Study	COMPLETED	Traumeel S Inj.	66

1 to 10 of 15Source ClinicalTrials.gov

See all 15 participant flow

Adverse events12

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Back pain	Musculoskeletal and connective tissue disorders	Traumeel S Inj.	3	72
other	Back pain	Musculoskeletal and connective tissue disorders	Fortecortin/Dexamethasone 8 mg Inj	1	67
other	Back pain	Musculoskeletal and connective tissue disorders	Saline Inj.	3	36
other	Neck pain	Musculoskeletal and connective tissue disorders	Traumeel S Inj.	4	72
other	Neck pain	Musculoskeletal and connective tissue disorders	Fortecortin/Dexamethasone 8 mg Inj	2	67
other	Neck pain	Musculoskeletal and connective tissue disorders	Saline Inj.	2	36
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Traumeel S Inj.	1	72
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Fortecortin/Dexamethasone 8 mg Inj	3	67
other	Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	Saline Inj.	2	36
serious	Auricular fibrillation	Cardiac disorders	Traumeel S Inj.	0	72	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Traumeel S Inj.
Total, all-cause mortality	Fortecortin/Dexamethasone 8 mg Inj
Total, all-cause mortality	Saline Inj.
Total, other adverse events	Traumeel S Inj.	8	72
Total, other adverse events	Fortecortin/Dexamethasone 8 mg Inj	6	67
Total, other adverse events	Saline Inj.	7	36
Total, serious adverse events	Traumeel S Inj.	0	72
Total, serious adverse events	Fortecortin/Dexamethasone 8 mg Inj	1	67
Total, serious adverse events	Saline Inj.	0	36

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
25649543	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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