Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dextrose 5% (D5W) Injection | Active Comparator | Glucose injection in 5% concentration, administered weekly X 4 times in a volume of 12 ml or less. |
|
| Physical Therapy | Active Comparator | Physical therapy for a month in the posterior deltoid region 3 times a week. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| NRS Pain (0-10 Numerical Rating Scale) | 0-10 Numerical Rating Scale for pain. | Time 0 and 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Quick Dash Score | Validated shortened version of Disabilities of Arm Shoulder and Hand score. | Time 0 and 1 month |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel Slullitel, PHD | Contact | 00543415012223 | mslullitel@gmail.com | |
| Ezequiel Mailand, MD | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Mailand Ezequiel, MD | Non affiliated | Study Director |
| Dean Reeves | Non Affiliated | Study Chair |
| David Rabago |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Scanner | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23481405 | Background | 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. | |
| 23850615 | Result | 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. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D020425 | Radial Neuropathy |
| ID | Term |
|---|---|
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D005947 | Glucose |
| D014867 | Water |
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D006601 | Hexoses |
| D009005 | Monosaccharides |
| D000073893 | Sugars |
| D002241 | Carbohydrates |
| D006878 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Physical therapy | Other | Three times weekly X 3 week sessions to include myofascial release, exercise, and one modality. |
|
| Non affiliated |
| Study Chair |
| Instituto Jaime Slullitel | Recruiting | Rosario | Santa Fe Province | 2000 | Argentina |
|
| 19549615 | Result | 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. |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |