Clinical trial NCT02331069: Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose
Official title: Delto-Tricipital Compression Syndrome: A Randomized Treatment Comparison Trial of Dextrose Injection Versus Physical Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Superficial Radial Nerve Lesion
Keywords: radial neuropathy
Lead sponsor: Universidad Abierta Interamericana
Sponsor class: OTHER
First posted: 2015-01-05
Enrollment: 80
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: NRS Pain (0-10 Numerical Rating Scale)
timeFrame: Time 0 and 1 month
Secondary outcomes:
measure: Quick Dash Score
timeFrame: Time 0 and 1 month
Other outcomes:
Locations:
city: Rosario
country: Argentina
facility: Clinica Scanner
state: Santa Fe
city: Rosario
country: Argentina
facility: Instituto Jaime Slullitel
state: Santa Fe
Study officials:
affiliation: Non affiliated
name: Mailand Ezequiel, MD
role: STUDY_DIRECTOR
affiliation: Non Affiliated
name: Dean Reeves
role: STUDY_CHAIR
affiliation: Non affiliated
name: David Rabago
role: STUDY_CHAIR
References:
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.
citation: 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.
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 Jun 22.