ITU Treatment for Chronic Epicondylitis Musculoskeletal Pain Reduction

NCT03255733 | Completed Results FDA Device

• 1 other identifier: GTS-ITU Epicondylosis 01
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates the effectiveness, safety and patient tolerance for the use of Intense Therapeutic Ultrasound (ITU) for chronic, subcutaneous lateral Epicondylitis musculoskeletal tissue pain reduction began in July 2015 and was completed in March 2017. The More Foundation/The Core Institute: Single-blinded pivotal study for the treatment of chronic lateral epicondylitis. A total 29 patients received 2 treatments, 4 weeks apart on subcutaneous musculoskeletal tissues along with Standard of Care treatments as prescribed by the Principal Investigator. Patients were followed for up to 6 months after the first treatment receiving a physical exam at each follow-up visit (4, 8 and 12 weeks) and provided feedback via Patient/Subject Reported Outcome Measure surveys specific to the treated anatomy at each visit and via phone follow-up at 26 weeks after the first treatment.

Conditions

Tennis Elbow

Keywords

Chronic Lateral Epicondylitis; Tennis Elbow; Intense Therapeutic Ultrasound (ITU); Guided Therapy Systems (GTS); Ardent Sound, Inc.; Actisound

Outcome Measures

Primary Outcomes (1)

• Percentage of Patients Reporting at Least 25% Overall Pain Reduction

  Percentage of Patients Reporting at least 25% pain reduction compared to baseline, using Universal Visual Analog Scale (VAS) Pain Score. VAS is a 10-point Pain Scale, where 0 = No Pain, 1 = Slight Pain and 10 = the Patients Worst Imaginable Pain. Scales in between represent 10% increments of Pain ( Range 1 - 10).

  12 weeks after 1st Treatment

Secondary Outcomes (1)

• Average Pain Score Change as Reported Using Patient Rated Tennis Elbow Evaluation, During Normal Activities

  12 weeks after 1st Treatment

Study Arms (1)

Intense Therapeutic Ultrasound Treatment

EXPERIMENTAL

Intense Therapeutic Ultrasound applied along and length and width of the Common Extensor Tendon. 80, 1 Joule pulses were applied twice, four weeks apart.

Device: Intense Therapeutic Ultrasound Treatment

Interventions

Intense Therapeutic Ultrasound Treatment DEVICE

Also known as: Guided Therapy Systems, Ardent Sound, GTS, ITU, Actisound

Intense Therapeutic Ultrasound Treatment

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Chronic Pain (\>90 days) from previously diagnosed Lateral Epicondylitis, where "Standard of Care" regimens failed to relief pain in the affected anatomy.
• No History of surgery to the affected anatomy.
• No alternative treatment procedures within the last 90 days.
• Unilateral Pain
• Willingness to complete treatment and post treatment regimen as described.
• Patients who have provided written and verbal informed consent.

You may not qualify if:

• Patients currently enrolled in any other non-conservative, device, or Investigational New Device (IND) clinical trial, or who have participated in a clinical study involving the Common Extensor Tendon, thirty days prior to study initiation;
• Patients who have participated in any other clinical study involving an investigational product 30 days prior to enrollment that, in the opinion of the Principal Investigator, could affect the outcome of this study;
• Patients who have received previous treatment in the symptomatic limb (not including conservative treatment);
• At the Principal Investigator's discretion, any patient that should be excluded based on their current condition or medical history.

Sponsors & Collaborators

• Guided Therapy Systems: lead
• More Foundation: collaborator

Study Sites (1)

The More Foundation

Phoenix, Arizona, 85023, United States

Location

Related Publications (8)

• White WM, Makin IR, Barthe PG, Slayton MH, Gliklich RE. Selective creation of thermal injury zones in the superficial musculoaponeurotic system using intense ultrasound therapy: a new target for noninvasive facial rejuvenation. Arch Facial Plast Surg. 2007 Jan-Feb;9(1):22-9. doi: 10.1001/archfaci.9.1.22.

  PMID: 17224484 BACKGROUND

• Alam M, White LE, Martin N, Witherspoon J, Yoo S, West DP. Ultrasound tightening of facial and neck skin: a rater-blinded prospective cohort study. J Am Acad Dermatol. 2010 Feb;62(2):262-9. doi: 10.1016/j.jaad.2009.06.039.

  PMID: 20115948 BACKGROUND

• Gliklich RE, White WM, Slayton MH, Barthe PG, Makin IR. Clinical pilot study of intense ultrasound therapy to deep dermal facial skin and subcutaneous tissues. Arch Facial Plast Surg. 2007 Mar-Apr;9(2):88-95. doi: 10.1001/archfaci.9.2.88.

  PMID: 17372061 BACKGROUND

• Laubach HJ, Makin IR, Barthe PG, Slayton MH, Manstein D. Intense focused ultrasound: evaluation of a new treatment modality for precise microcoagulation within the skin. Dermatol Surg. 2008 May;34(5):727-34. doi: 10.1111/j.1524-4725.2008.34196.x.

  PMID: 18429926 BACKGROUND

• Molloy T, Wang Y, Murrell G. The roles of growth factors in tendon and ligament healing. Sports Med. 2003;33(5):381-94. doi: 10.2165/00007256-200333050-00004.

  PMID: 12696985 BACKGROUND

• Charan J, Biswas T. How to calculate sample size for different study designs in medical research? Indian J Psychol Med. 2013 Apr;35(2):121-6. doi: 10.4103/0253-7176.116232.

  PMID: 24049221 BACKGROUND

• DiGiovanni BF, Nawoczenski DA, Lintal ME, Moore EA, Murray JC, Wilding GE, Baumhauer JF. Tissue-specific plantar fascia-stretching exercise enhances outcomes in patients with chronic heel pain. A prospective, randomized study. J Bone Joint Surg Am. 2003 Jul;85(7):1270-7. doi: 10.2106/00004623-200307000-00013.

  PMID: 12851352 BACKGROUND

• Rompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.

  PMID: 17254903 BACKGROUND

MeSH Terms

Conditions

Tennis Elbow

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries

Limitations and Caveats

While the protocol involved Chronic patients, who had already failed Standard of Care regimens, it is a limitation for this investigational study to have no control group.

Results Point of Contact

• Title: Rich Amodei, RDMS
• Organization: Guided Therapy Systems

r.amodei@guidedtherapy.com

480-649-8587

Study Officials

• John A Kearney, MD

  The More Foundataion

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Investigator was blinded to the Patient Reported Outcome Measure Survey details and analysis.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients age 18 - 85, previously diagnosed with Chronic Lateral Epicondylitis, with symptoms exceeding 90 days, and where Standard of Care treatments have failed to resolve the symptoms.

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: August 21, 2017
• Study Start: July 14, 2015
• Primary Completion: March 13, 2017
• Study Completion: March 13, 2017
• Last Updated: November 17, 2017
• Results First Posted: November 17, 2017

Record last verified: 2017-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)