Clinical trial NCT03683901: The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
Official title: The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stroke
Keywords: Electrical stimulation therapy
TENS
t-NMES
Stroke
Lead sponsor: MetroHealth Medical Center
Sponsor class: OTHER
First posted: 2018-09-25
Enrollment: 10
Sex: ALL
Minimum age (years): 21
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Cohort study; single group but with random serial allocation of treatment type
Primary purpose: TREATMENT

Brief summary: Examination of the effects of short-term use of TENS and t-NMES on passive pain-free ROM of the painful post-stroke shoulder. Treatments are compared with no stimulation.

Detailed description: Single cohort, cross-over study. Subjects undergo passive pain-free ROM of the painful post-stroke shoulder under 3 stimulation conditions. The stimulation was delivered by a trained occupational therapist under three conditions: 10 seconds of TENS, 10 seconds of t-NMES, and 10 seconds of no stimulation. Each subject was exposed to each of the three stimulation conditions three times in a computer-generated random sequence for each outcome measure with a 5-minute wash-out period between each stimulation. This protocol is repeated for each of the two passive movements tested, shoulder abduction and shoulder external rotation.

Eligibility criteria: Inclusion Criteria:

* at least 3 months post-stroke
* worst shoulder pain in the last week at least 4 on the 0-10 numerical rating scale,
* adequate cognitive ability to be able to rate their pain in the past week

Exclusion Criteria:

* history of tachyarrhythmia with decreased blood pressure
* uncontrolled seizures (defined as more than one per month)
* an implanted electrical device
* uncompensated hemi-neglect

Primary outcomes:
measure: Passive Range of Motion of Shoulder in Shoulder External Rotation
timeFrame: 10 seconds
measure: Passive Range of Motion of Shoulder in Shoulder Abduction
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: MetroHealth Medical Center
name: John Chae, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Chantraine A, Baribeault A, Uebelhart D, Gremion G. Shoulder pain and dysfunction in hemiplegia: effects of functional electrical stimulation. Arch Phys Med Rehabil. 1999 Mar;80(3):328-31. doi: 10.1016/s0003-9993(99)90146-6.
citation: Faghri PD, Rodgers MM, Glaser RM, Bors JG, Ho C, Akuthota P. The effects of functional electrical stimulation on shoulder subluxation, arm function recovery, and shoulder pain in hemiplegic stroke patients. Arch Phys Med Rehabil. 1994 Jan;75(1):73-9.
citation: Leandri M, Parodi CI, Corrieri N, Rigardo S. Comparison of TENS treatments in hemiplegic shoulder pain. Scand J Rehabil Med. 1990;22(2):69-71.
citation: Roosink M, Renzenbrink GJ, Buitenweg JR, van Dongen RT, Geurts AC, Ijzerman MJ. Somatosensory symptoms and signs and conditioned pain modulation in chronic post-stroke shoulder pain. J Pain. 2011 Apr;12(4):476-85. doi: 10.1016/j.jpain.2010.10.009. Epub 2010 Dec 17.
citation: Sluka KA, Deacon M, Stibal A, Strissel S, Terpstra A. Spinal blockade of opioid receptors prevents the analgesia produced by TENS in arthritic rats. J Pharmacol Exp Ther. 1999 May;289(2):840-6.
citation: Soo Hoo J, Paul T, Chae J, Wilson RD. Central hypersensitivity in chronic hemiplegic shoulder pain. Am J Phys Med Rehabil. 2013 Jan;92(1):1-9; quiz 10-3. doi: 10.1097/PHM.0b013e31827df862.