Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

Delto-Tricipital Compression Syndrome: A Randomized Treatment Comparison Trial of Dextrose Injection Versus Physical Therapy.

The posterior antebrachial cutaneous nerve (PACN) can be compressed between the deltoid and triceps, with resultant pain and dysfunction. The active treatment for this study will be injection of the point of compression and along the painful course of the sensory nerve with 5% dextrose. The control treatment will be physical therapy.

Study Overview

• Status: Unknown
• Conditions: Superficial Radial Nerve Lesion
• Intervention / Treatment: Drug: Dextrose 5% (D5W); Other: Physical therapy

Detailed Description

The PACN is a purely sensory nerve that originates in the midforearm, courses anterior to the lateral epicondyle, and travels proximally until it dives between the posterior portion of the V shaped insertion of the deltoid and the external? insertion of the triceps, whereupon it joins with the radial nerve.

A proposed pathological explanation is that repetitive co-contraction produces irritation and compression of the nerve at the delto-tricipital (D-T) fascial penetration point. Clinically the patient experiences pain localized to that compression point, and traveling distally along the course of some or all of the posterior femoral cutaneous nerve.

Perineural injection of dextrose has been previously reported for therapeutic use in chronic pain associated with Achilles tendinopathy. Empirically,injection of D5W with a small needle along the course of the PACN and at the D-T penetrator has been found to resolve both pain and dysfunction (describe dysfunction).

Participants will be randomly assigned to either 1 month of physical therapy or to 0,1,2 and 3 week injection of D5W. The use of standardized measurement tools for pain (0-10 numerical rating scale) and function (Quick DASH) will be utilized to determine baseline status and status at 1 month. At 1 month, subjects receiving therapy will be allowed to cross over to injection treatment and all participants will receive as needed treatment until the 1 year period of follow-up. Thus only 1 month data is randomized but long term data will be gathered.

• Study Type: Interventional
• Enrollment (Anticipated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Miguel Slullitel, PHD; Phone Number: 00543415012223; Email: mslullitel@gmail.com
• Study Contact Backup: Name: Ezequiel Mailand, MD

Study Locations

• Argentina
  • Santa Fe
    • Rosario, Santa Fe, Argentina, 2000
      • Recruiting
      • Clinica Scanner
      • Contact: Ezequiel Mailand, MD; Phone Number: 0054 341 6393318; Email: ezmailand@gmail.com
      • Contact: Daniel Mailand, MD; Phone Number: 0054 341 6393339; Email: dmailand@gmail.com
    • Rosario, Santa Fe, Argentina, 2000
      • Recruiting
      • Instituto Jaime Slullitel
      • Contact: MigueL Slullitel, PHD; Phone Number: 0054 341 5012223; Email: mslullitel@gmail.com
      • Contact: Ezequiel Mailand, MD; Phone Number: 0054 314 6393318; Email: ezmailand@gmail.com
      • Principal Investigator: Miguel H Slullitel, Phd
      • Sub-Investigator: Ezequiel Mailand, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Pain in the deltotricipital groove,extending down the lateral septum.
2. Pain rating 6 or more on a 0-10 numerical rating scale (NRS)
3. Reproduction of pain with provocative maneuvers. Lifting a 6 pound weight to 60 degrees with the below at 40 degrees of elbow extension and the clinician creating a flexion force on the elbow which the participant resists. (Need a picture)
4. Pain more than 3 months?

Exclusion Criteria:

1. Pain in other arm or shoulder locations on either side more than 2/10
2. Pain in other part of the body more than 4/10.
3. Taking narcotics for pain.
4. Pain with testing of shoulder laxity.
5. Massive rupture of rotator cuff (complete width tear) evidenced by examination or MRI scan.
6. Level III-IV or more shoulder arthritis on plain film of shoulder.
7. Other peripheral neuropathy.
8. Unstable psychiatric status

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Dextrose 5% (D5W) Injection; Glucose injection in 5% concentration, administered weekly X 4 times in a volume of 12 ml or less.	Drug: Dextrose 5% (D5W); 0,1,2, and 3 week injection sessions consisting of injection of 2 ml of D5W into the D-T groove at the point of maximal pain at 1-2 cm depth, followed by subcutaneous injection of D5W at 4 cm intervals along the course of the PACN if tenderness is present.; Other Names: glucose 5% in water
Active Comparator: Physical Therapy; Physical therapy for a month in the posterior deltoid region 3 times a week.	Other: Physical therapy; Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
NRS Pain (0-10 Numerical Rating Scale)	0-10 Numerical Rating Scale for pain.	Time 0 and 1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quick Dash Score	Validated shortened version of Disabilities of Arm Shoulder and Hand score.	Time 0 and 1 month

Collaborators and Investigators

• Sponsor: Universidad Abierta Interamericana
• Investigators: Study Director: Mailand Ezequiel, MD, Non Affiliated; Study Chair: Dean Reeves, Non Affiliated; Study Chair: David Rabago, Non Affiliated

Publications and helpful links

General Publications

• Yelland MJ, Sweeting KR, Lyftogt JA, Ng SK, Scuffham PA, Evans KA. Prolotherapy injections and eccentric loading exercises for painful Achilles tendinosis: a randomised trial. Br J Sports Med. 2011 Apr;45(5):421-8. doi: 10.1136/bjsm.2009.057968. Epub 2009 Jun 22.
• Sorensen AA, Howard D, Tan WH, Ketchersid J, Calfee RP. Minimal clinically important differences of 3 patient-rated outcomes instruments. J Hand Surg Am. 2013 Apr;38(4):641-9. doi: 10.1016/j.jhsa.2012.12.032. Epub 2013 Mar 6.
• Rabago D, Kijowski R, Woods M, Patterson JJ, Mundt M, Zgierska A, Grettie J, Lyftogt J, Fortney L. Association between disease-specific quality of life and magnetic resonance imaging outcomes in a clinical trial of prolotherapy for knee osteoarthritis. Arch Phys Med Rehabil. 2013 Nov;94(11):2075-82. doi: 10.1016/j.apmr.2013.06.025. Epub 2013 Jul 10.

Study record dates

Study Major Dates

• Study Start: January 1, 2015
• Primary Completion (Anticipated): January 1, 2016
• Study Completion (Anticipated): January 1, 2017

Study Registration Dates

• First Submitted: December 17, 2014
• First Submitted That Met QC Criteria: January 1, 2015
• First Posted (Estimate): January 5, 2015

Study Record Updates

• Last Update Posted (Estimate): March 17, 2015
• Last Update Submitted That Met QC Criteria: March 13, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: radial neuropathy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neuromuscular Diseases; Mononeuropathies; Peripheral Nervous System Diseases; Radial Neuropathy
• Other Study ID Numbers: UAI Protocol number 01006