Delto-Tricipital Compression Syndrome: Treated With Injection of Dextrose

Sponsor
Universidad Abierta Interamericana (Other)
Overall Status
Unknown status
CT.gov ID
NCT02331069
Collaborator
(none)
80
2
2
24
40
1.7

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Dextrose 5% (D5W)
  • Other: Physical therapy
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Delto-Tricipital Compression Syndrome: A Randomized Treatment Comparison Trial of Dextrose Injection Versus Physical Therapy.
Study Start Date :
Jan 1, 2015
Anticipated Primary Completion Date :
Jan 1, 2016
Anticipated Study Completion Date :
Jan 1, 2017

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Dextrose 5% (D5W) Injection

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

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 Names:
  • glucose 5% in water
  • Active Comparator: Physical Therapy

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

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

    Outcome Measures

    Primary Outcome Measures

    1. NRS Pain (0-10 Numerical Rating Scale) [Time 0 and 1 month]

      0-10 Numerical Rating Scale for pain.

    Secondary Outcome Measures

    1. Quick Dash Score [Time 0 and 1 month]

      Validated shortened version of Disabilities of Arm Shoulder and Hand score.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years to 80 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinica Scanner Rosario Santa Fe Argentina 2000
    2 Instituto Jaime Slullitel Rosario Santa Fe Argentina 2000

    Sponsors and Collaborators

    • Universidad Abierta Interamericana

    Investigators

    • Study Director: Mailand Ezequiel, MD, Non affiliated
    • Study Chair: Dean Reeves, Non Affiliated
    • Study Chair: David Rabago, Non affiliated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Miguel Slullitel, Professor of Orthopedic Surgery, Universidad Abierta Interamericana
    ClinicalTrials.gov Identifier:
    NCT02331069
    Other Study ID Numbers:
    • UAI Protocol number 01006
    First Posted:
    Jan 5, 2015
    Last Update Posted:
    Mar 17, 2015
    Last Verified:
    Mar 1, 2015
    Keywords provided by Miguel Slullitel, Professor of Orthopedic Surgery, Universidad Abierta Interamericana
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 17, 2015