The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder

Stroke Clinical Trial

Official title:

The Effect of Electrical Stimulation on Impairment of the Painful Post-Stroke Shoulder

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683901
• Other study ID #: IRB10-00491
• Status: Completed
• Phase: N/A
• Start date: December 27, 2010
• Est. completion date: May 1, 2011

Study information

• Verified date: August 2019
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: May 1, 2011
• Est. primary completion date: May 1, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Stroke

Intervention

Device:
• TENS
Electrical Stimulation
• t-NMES
Electrical Stimulation

Other:
• No stimulation
No stimulation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Passive Range of Motion of Shoulder in Shoulder External Rotation	passive range of motion of shoulder in shoulder external rotation as measured with hand-held goniometer	10 seconds
Primary	Passive Range of Motion of Shoulder in Shoulder Abduction	passive range of motion of shoulder in shoulder abduction as measured with hand-held goniometer	10 seconds