Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

NCT ID: NCT02331069

Last Updated: 2015-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2017-01-31

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.

Conditions

Superficial Radial Nerve Lesion

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Dextrose 5% (D5W) Injection

Glucose injection in 5% concentration, administered weekly X 4 times in a volume of 12 ml or less.

Group Type: ACTIVE_COMPARATOR

Dextrose 5% (D5W)

Intervention Type: DRUG

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.

Physical Therapy

Physical therapy for a month in the posterior deltoid region 3 times a week.

Group Type: ACTIVE_COMPARATOR

Physical therapy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: DRUG

Physical therapy

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

Intervention Type: OTHER

Other Intervention Names

glucose 5% in water

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Universidad Abierta Interamericana

OTHER

Sponsor Role: lead

Responsible Party

Miguel Slullitel

Professor of Orthopedic Surgery

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mailand Ezequiel, MD

Role: STUDY_DIRECTOR

Non affiliated

Dean Reeves

Role: STUDY_CHAIR

Non Affiliated

David Rabago

Role: STUDY_CHAIR

Non affiliated

Locations

Clinica Scanner

Rosario, Santa Fe Province, Argentina

Site Status: RECRUITING

Instituto Jaime Slullitel

Rosario, Santa Fe Province, Argentina

Site Status: RECRUITING

Countries

Argentina

Central Contacts

Miguel Slullitel, PHD

Role: CONTACT

mslullitel@gmail.com

00543415012223

Ezequiel Mailand, MD

Role: CONTACT

Facility Contacts

Ezequiel Mailand, MD

Role: primary

ezmailand@gmail.com

0054 341 6393318

Daniel Mailand, MD

Role: backup

dmailand@gmail.com

0054 341 6393339

MigueL Slullitel, PHD

Role: primary

mslullitel@gmail.com

0054 341 5012223

Ezequiel Mailand, MD

Role: backup

ezmailand@gmail.com

0054 314 6393318

References

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.

Reference Type: BACKGROUND

PMID: 23481405 (View on PubMed)

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.

Reference Type: RESULT

PMID: 23850615 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19549615 (View on PubMed)

Other Identifiers

UAI Protocol number 01006

Identifier Type: -

Identifier Source: org_study_id