NCT02331069

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 17, 2014

Completed
15 days until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 5, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

March 17, 2015

Status Verified

March 1, 2015

Enrollment Period

1 year

First QC Date

December 17, 2014

Last Update Submit

March 13, 2015

Conditions

Superficial Radial Nerve Lesion

Keywords

radial neuropathy

Outcome Measures

Primary Outcomes (1)

  • NRS Pain (0-10 Numerical Rating Scale)

    0-10 Numerical Rating Scale for pain.

    Time 0 and 1 month

Secondary Outcomes (1)

  • Quick Dash Score

    Time 0 and 1 month

Study Arms (2)

Dextrose 5% (D5W) Injection

ACTIVE COMPARATOR

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

Drug: Dextrose 5% (D5W)

Physical Therapy

ACTIVE COMPARATOR

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

Other: Physical therapy

Interventions

Dextrose 5% (D5W)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.

Also known as: glucose 5% in water
Dextrose 5% (D5W) Injection
Physical therapyOTHER

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

Physical Therapy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pain in the deltotricipital groove,extending down the lateral septum.
  • Pain rating 6 or more on a 0-10 numerical rating scale (NRS)
  • 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)
  • Pain more than 3 months?

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Clinica Scanner

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Instituto Jaime Slullitel

Rosario, Santa Fe Province, 2000, Argentina

RECRUITING

Related Publications (3)

  • 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.

    PMID: 23481405BACKGROUND

  • 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.

    PMID: 23850615RESULT

  • 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.

    PMID: 19549615RESULT

MeSH Terms

Conditions

Radial Neuropathy

Interventions

GlucoseWaterPhysical Therapy Modalities

Condition Hierarchy (Ancestors)

MononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesHydroxidesAlkaliesInorganic ChemicalsAnionsIonsElectrolytesOxidesOxygen CompoundsTherapeuticsRehabilitation

Study Officials

  • Mailand Ezequiel, MD

    Non affiliated

    STUDY DIRECTOR

  • Dean Reeves

    Non Affiliated

    STUDY CHAIR

  • David Rabago

    Non affiliated

    STUDY CHAIR

Central Study Contacts

Miguel Slullitel, PHD

CONTACT

00543415012223mslullitel@gmail.com

Ezequiel Mailand, MD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Orthopedic Surgery

Study Record Dates

First Submitted

December 17, 2014

First Posted

January 5, 2015

Study Start

January 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2017

Last Updated

March 17, 2015

Record last verified: 2015-03

Locations

AR(2)