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Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

Primary Purpose

Superficial Radial Nerve Lesion

Status
Unknown status
Phase
Not Applicable
Locations
Argentina
Study Type
Interventional
Intervention
Dextrose 5% (D5W)
Physical therapy
Sponsored by
Universidad Abierta Interamericana
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Superficial Radial Nerve Lesion focused on measuring radial neuropathy

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Clinica ScannerRecruiting
  • Instituto Jaime SlullitelRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Dextrose 5% (D5W) Injection

Physical Therapy

Arm Description

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

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

Outcomes

Primary Outcome Measures

NRS Pain (0-10 Numerical Rating Scale)
0-10 Numerical Rating Scale for pain.

Secondary Outcome Measures

Quick Dash Score
Validated shortened version of Disabilities of Arm Shoulder and Hand score.

Full Information

First Posted
December 17, 2014
Last Updated
March 13, 2015
Sponsor
Universidad Abierta Interamericana
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1. Study Identification

Unique Protocol Identification Number
NCT02331069
Brief Title
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

2. Study Status

Record Verification Date
March 2015
Overall Recruitment Status
Unknown status
Study Start Date
January 2015 (undefined)
Primary Completion Date
January 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad Abierta Interamericana

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Superficial Radial Nerve Lesion
Keywords
radial neuropathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dextrose 5% (D5W) Injection
Arm Type
Active Comparator
Arm Description
Glucose injection in 5% concentration, administered weekly X 4 times in a volume of 12 ml or less.
Arm Title
Physical Therapy
Arm Type
Active Comparator
Arm Description
Physical therapy for a month in the posterior deltoid region 3 times a week.
Intervention Type
Drug
Intervention Name(s)
Dextrose 5% (D5W)
Other Intervention Name(s)
glucose 5% in water
Intervention Description
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
Other
Intervention Name(s)
Physical therapy
Intervention Description
Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality.
Primary Outcome Measure Information:
Title
NRS Pain (0-10 Numerical Rating Scale)
Description
0-10 Numerical Rating Scale for pain.
Time Frame
Time 0 and 1 month
Secondary Outcome Measure Information:
Title
Quick Dash Score
Description
Validated shortened version of Disabilities of Arm Shoulder and Hand score.
Time Frame
Time 0 and 1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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? Exclusion Criteria: 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Miguel Slullitel, PHD
Phone
00543415012223
Email
mslullitel@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ezequiel Mailand, MD
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mailand Ezequiel, MD
Organizational Affiliation
Non affiliated
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Dean Reeves
Organizational Affiliation
Non Affiliated
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
David Rabago
Organizational Affiliation
Non affiliated
Official's Role
Study Chair
Facility Information:
Facility Name
Clinica Scanner
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ezequiel Mailand, MD
Phone
0054 341 6393318
Email
ezmailand@gmail.com
First Name & Middle Initial & Last Name & Degree
Daniel Mailand, MD
Phone
0054 341 6393339
Email
dmailand@gmail.com
Facility Name
Instituto Jaime Slullitel
City
Rosario
State/Province
Santa Fe
ZIP/Postal Code
2000
Country
Argentina
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MigueL Slullitel, PHD
Phone
0054 341 5012223
Email
mslullitel@gmail.com
First Name & Middle Initial & Last Name & Degree
Ezequiel Mailand, MD
Phone
0054 314 6393318
Email
ezmailand@gmail.com
First Name & Middle Initial & Last Name & Degree
Miguel H Slullitel, Phd
First Name & Middle Initial & Last Name & Degree
Ezequiel Mailand, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
23481405
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.
Results Reference
background
PubMed Identifier
23850615
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.
Results Reference
result
PubMed Identifier
19549615
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.
Results Reference
result

Learn more about this trial

Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

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