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

NCT03683901 | Completed Results

• 1 other identifier: IRB10-00491
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Stroke

Keywords

Electrical stimulation therapy; TENS; t-NMES; Stroke

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

TENS/t-NMES/No stimulation

EXPERIMENTAL

TENS stimulation parameters were of a symmetric waveform, a frequency of 100 Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #7) applied for 10 seconds. t-NMES parameters were a symmetric waveform with 2 second ramp-up and 2 second ramp-down, a frequency of 35Hz, and a pulse duration of 300 microseconds (EMPI 300PVTM program PPR #3). The t-NMES current intensity was set by adjusting the amplitude to yield the strongest contraction of the underlying muscles without initiating pain. Device and electrodes remained in place but no stimulation was delivered over the 10 second interval. Exposed to each stimulation 3 times for each shoulder ROM.

Device: TENS; Device: t-NMES; Other: No stimulation

Interventions

TENS DEVICE

Electrical Stimulation

Also known as: Transcutaneous Electrical Nerve Stimulation

TENS/t-NMES/No stimulation

t-NMES DEVICE

Electrical Stimulation

Also known as: transcutaneous-Neuromuscular Electrical Stimulation

TENS/t-NMES/No stimulation

No stimulation OTHER

No stimulation

TENS/t-NMES/No stimulation

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Related 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. doi: 10.1016/s0003-9993(99)90146-6.

  PMID: 10084443 BACKGROUND

• 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.

  PMID: 8291967 BACKGROUND

• 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.

  PMID: 2363027 BACKGROUND

• 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.

  PMID: 21167792 BACKGROUND

• 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.

  PMID: 10215661 BACKGROUND

• 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.

  PMID: 23255268 BACKGROUND

MeSH Terms

Conditions

Stroke

Interventions

Transcutaneous Electric Nerve Stimulation

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Electric Stimulation Therapy; Therapeutics; Physical Therapy Modalities; Rehabilitation; Analgesia; Anesthesia and Analgesia

Limitations and Caveats

Electrode placement was determined to provide best possible response for the two movements and stimulation types to maintain blinding; however, may have led to a sub-optimal location for either or both types of stimulation. Small sample size.

Results Point of Contact

• Title: Dr. Victoria Whitehair
• Organization: MetroHealth Rehabilitation Institute

vwhitehair@metrohealth.org

216-778-4414

Study Officials

• John Chae, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: Participant, Investigator, and Outcomes Assessor were masked to the particular stimulation during each range of motion assessment
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: VP Research Instititute; Chair, Department of PM&R

Model Details: Cohort study; single group but with random serial allocation of treatment type

Study Record Dates

• First Submitted: September 23, 2018
• First Posted: September 25, 2018
• Study Start: December 27, 2010
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: September 16, 2019
• Results First Posted: September 16, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share