Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

Superficial Radial Nerve Lesion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02331069
• Other study ID #: UAI Protocol number 01006
• Status: Recruiting
• Phase: N/A
• First received: December 17, 2014
• Last updated: March 13, 2015
• Start date: January 2015
• Est. completion date: January 2017

Study information

• Verified date: March 2015
• Source: Universidad Abierta Interamericana
• Contact: Miguel Slullitel, PHD
• Phone: 00543415012223
• Email: mslullitel[@]gmail.com
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: January 2017
• Est. primary completion date: January 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 80 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radial Neuropathy
• Superficial Radial Nerve Lesion

Intervention

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:
• Physical therapy
Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality.

Locations

Country	Name	City	State
Argentina	Clinica Scanner	Rosario	Santa Fe
Argentina	Instituto Jaime Slullitel	Rosario	Santa Fe

Sponsors (1)

Lead Sponsor	Collaborator
Universidad Abierta Interamericana

Country where clinical trial is conducted

Argentina, 

References & Publications (3)

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. Ar — View Citation

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. — View Citation

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	NRS Pain (0-10 Numerical Rating Scale)	0-10 Numerical Rating Scale for pain.	Time 0 and 1 month	No
Secondary	Quick Dash Score	Validated shortened version of Disabilities of Arm Shoulder and Hand score.	Time 0 and 1 month	No