## Protocol Section
### Identification Module
**NCT ID:** NCT01269879

**Acronym:** VIBES

**Brief Title:** VIBration Training in EpicondylitiS

**Official Title:** Vibration Training in Epicondylitis - a Randomized Trial

#### Organization Study ID Info
**ID:** VIBES-2010
#### Organization
**Class:** OTHER
**Full Name:** Hannover Medical School
### Status Module
#### Completion Date
**Date:** 2011-09

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2011-01-04

**Type:** ESTIMATED

**Last Update Submit Date:** 2011-01-03

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2011-09

**Type:** ESTIMATED

#### Start Date
**Date:** 2011-01

**Status Verified Date:** 2011-01

#### Study First Post Date
**Date:** 2011-01-04
**Type:** ESTIMATED
**Study First Submit Date:** 2011-01-03
**Study First Submit QC Date:** 2011-01-03
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hannover Medical School

#### Responsible Party

**Old Name Title:** Hannover Medical School, Karsten Knobloch, MD, PHD, FACS

**Old Organization:** Hannover Medical School, Plastic, Hand and Reconstructive Surgery

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** A number of different therapeutic approaches to treat lateral epicondylitis have been tested partly in randomized trials, such as polidocanol sclerosing injections, botulinom toxin A injections, braces, surgery and topical NO patches.

One study indicates that patients with lateral epicondylitis (lateral elbow tendinopathy) have poorer elbow proprioception in contrast to healthy controls (Juul-Kristensen B, et al., J Shoulder Elbow Surg 2008;17(1 Suppl):72S-81S.)

Based on a suggested poorer elbow proprioception in lateral elbow tendinopathy, The investigators hypothesize that a dedicated proprioceptive intervention might be able to reduce pain and improve function.

As such a RCT is planned with two intervention arms with proprioceptive training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) over twelve weeks.

**Detailed Description:** The investigators sought to evaluate the clinical effects of either a vibration training using the Flexi-Bar vibration device (www.flexi-bar.co.uk) +/- the XCO-Trainer (www.xco-trainer.co.uk) in a randomized trial among patients suffering lateral elbow tendinopathy (lateral epicondylitis).

Primary outcome measure of this clinical trial is pain on a visual analogue scale (VAS 0-10) before and after 12 weeks of training.

Secondary outcome parameters involve DASH score before and after, grip strength (JAMAR), vibration and two-point discrimination (mm).

### Conditions Module

**Conditions:**

- Epicondylitis

- Pain

- Tendinopathy

**Keywords:**

- epicondylitis

- pain

- tendon

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 70

**Type:** ESTIMATED

**Phases:**

- PHASE3

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Flexi-Bar vibration training only over 12 weeks with three distinct exercises and 10min training twice daily

**Intervention Names:**

- Device: Flexi-Bar vibration device only

**Label:** Active control (Flexi-Bar only)

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** Combination intervention using vibration device Flexi-Bar and XCO-Trainer (oscillating mass witin a tube moved during running 40-60min/week suggested)

**Intervention Names:**

- Device: Flexi-Bar + XCO-Trainer

**Label:** Intervention Flexi-Bar + XCO-Trainer

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Active control (Flexi-Bar only)

**Description:** daily vibration training 10min twice

**Name:** Flexi-Bar vibration device only

**Other Names:**

- vibration

- Flexi bar

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- Intervention Flexi-Bar + XCO-Trainer

**Description:** XCO-Trainer is a way to overload the cardiovascular system and the core muscles during running. An oscillating mass inside the XCO-Trainer is activated when the XCO is propelled forward and backward with force. The movement of the mass triggers a series of responses from the runners' body.

In addition Flexi-Bar vibration training as in the referred active comparator group

**Name:** Flexi-Bar + XCO-Trainer

**Other Names:**

- XCO

- XCO Trainer

- Flexibar

- vibration

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Pain on VAS (0=no pain at all, 10= worst pain imaginable) before and 12 weeks after the intervention.

**Measure:** Pain on a visual analogue scale (VAS 0-10)

**Time Frame:** before and 12 weeks after

#### Secondary Outcomes

**Description:** DASH score (0=no impairment, 100=severe impairment) of daily activities

**Measure:** DASH Score

**Time Frame:** before and 12 weeks after

**Description:** Grip strength (JAMAR) in two elbow positions (0° flexion, 90° flexion) before and after 12 weeks of intervention

**Measure:** Grip strength (JAMAR)

**Time Frame:** before and after 12 weeks

**Description:** Vibration using a 128Hz tuning fork before and 12 weeks after the intervention

**Measure:** Vibration

**Time Frame:** before and 12 weeks after

**Description:** 2-point discrimination (mm) before and after the intervention and the finger tips

**Measure:** 2-point discrimination

**Time Frame:** before and 12 weeks after the intervention

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* lateral elbow tendinopathy
* informed consent
* ability to run at least 40-60min per week with a XCO-Trainer device

Exclusion Criteria:

* other sources of lateral elbow pain (joint instabilities, fractures)
* no consent
* no ability to run at least 40-60min per week using a XCO-Trainer device

**Maximum Age:** 65 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** knobloch.karsten@mh-hannover.de

**Name:** Karsten Knobloch, FACS, MD, PhD

**Phone:** +495115328864

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Hannover

**Contacts:**

***Contact 1:***

- **Email:** knobloch.karsten@mh-hannover.de

- **Name:** Karsten Knobloch, MD, PhD, FACS

- **Phone:** +495115328864

- **Role:** CONTACT

***Contact 2:***

- **Name:** Karsten Knobloch, MD, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Germany

**Facility:** Hannover Medical School, Plastic, Hand and Reconstructive Surgery

**Zip:** 30625

#### Overall Officials

**Official 1:**

**Affiliation:** Hannover Medical School

**Name:** Karsten Knobloch, FACS, MD, PhD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Knobloch K. Lateral elbow tendinopathy. Am J Sports Med. 2010 Nov;38(11):NP3; author reply NP3-4. doi: 10.1177/0363546510383492. No abstract available.

**PMID:** 20971969

**Citation:** Knobloch K. [Non-operative therapy in lateral epicondylitis]. MMW Fortschr Med. 2009 Feb 19;151(8):28-30. No abstract available. German.

**PMID:** 19432271

**Citation:** Knobloch K. Re: Radiofrequency microtenotomy: a promising method for treatment of recalcitrant lateral epicondylitis. Am J Sports Med. 2008 Nov;36(11):e2-3; author reply e3. doi: 10.1177/0363546508325661. No abstract available.

**PMID:** 18978181

**Citation:** Knobloch K, Spies M, Busch KH, Vogt PM. Sclerosing therapy and eccentric training in flexor carpi radialis tendinopathy in a tennis player. Br J Sports Med. 2007 Dec;41(12):920-1. doi: 10.1136/bjsm.2007.036558. Epub 2007 May 11.

**PMID:** 17496066

**Citation:** Knobloch K. [Eccentric exercise in tendinopathies]. Sportverletz Sportschaden. 2010 Dec;24(4):187. doi: 10.1055/s-0029-1245845. Epub 2010 Dec 14. No abstract available. German.

**PMID:** 21157652

**Citation:** Knobloch K, Gohritz A. Dr Runge: a German pioneer in sclerosing therapy in epicondylitis in 1873. Br J Sports Med. 2010 Nov 16. doi: 10.1136/bjsm.2008.051326. Online ahead of print. No abstract available.

**PMID:** 21081643

**Citation:** Yoon U, Knobloch K. Reporting quality in evidence-based studies. J Am Coll Surg. 2010 Apr;210(4):533. doi: 10.1016/j.jamcollsurg.2009.12.028. No abstract available.

**PMID:** 20347748

**Citation:** Yoon U, Knobloch K. Quality of reporting in sports injury prevention abstracts according to the CONSORT and STROBE criteria: an analysis of the World Congress of Sports Injury Prevention in 2005 and 2008. Br J Sports Med. 2012 Mar;46(3):202-6. doi: 10.1136/bjsm.2008.053876. Epub 2009 Jul 26.

**PMID:** 19656768

**Citation:** Juul-Kristensen B, Lund H, Hansen K, Christensen H, Danneskiold-Samsoe B, Bliddal H. Poorer elbow proprioception in patients with lateral epicondylitis than in healthy controls: a cross-sectional study. J Shoulder Elbow Surg. 2008 Jan-Feb;17(1 Suppl):72S-81S. doi: 10.1016/j.jse.2007.07.003. Epub 2007 Nov 26.

**PMID:** 18036844

**Citation:** Garg R, Adamson GJ, Dawson PA, Shankwiler JA, Pink MM. A prospective randomized study comparing a forearm strap brace versus a wrist splint for the treatment of lateral epicondylitis. J Shoulder Elbow Surg. 2010 Jun;19(4):508-12. doi: 10.1016/j.jse.2009.12.015. Epub 2010 Apr 2.

**PMID:** 20363158

**Citation:** Mileva KN, Kadr M, Amin N, Bowtell JL. Acute effects of Flexi-bar vs. Sham-bar exercise on muscle electromyography activity and performance. J Strength Cond Res. 2010 Mar;24(3):737-48. doi: 10.1519/JSC.0b013e3181c7c2d8.

**PMID:** 20145560

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009135

- Term: Muscular Diseases

- ID: D000009140

- Term: Musculoskeletal Diseases

- ID: D000013708

- Term: Tendon Injuries

- ID: D000014947

- Term: Wounds and Injuries

- ID: D000070639

- Term: Elbow Tendinopathy

- ID: D000092464

- Term: Elbow Injuries

- ID: D000001134

- Term: Arm Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC05

- Name: Musculoskeletal Diseases

- Abbrev: BC26

- Name: Wounds and Injuries

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC10

- Name: Nervous System Diseases

### Condition Browse Module - Browse Leaves

- ID: M27013

- Name: Tendinopathy

- Relevance: HIGH

- As Found: Tendinopathy

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

- ID: M16486

- Name: Tennis Elbow

- Relevance: HIGH

- As Found: Epicondylitis

- ID: M12092

- Name: Muscular Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12097

- Name: Musculoskeletal Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M16479

- Name: Tendon Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M627

- Name: Elbow Tendinopathy

- Relevance: LOW

- As Found: Unknown

- ID: M2926

- Name: Elbow Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M4444

- Name: Arm Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000052256

- Term: Tendinopathy

- ID: D000013716

- Term: Tennis Elbow

### Misc Info Module

- Version Holder: 2024-05-24
