Electrical Stimulation for the Treatment of Post-Stroke Shoulder Pain

NCT01094301 | Completed Results

• 1 other identifier: NDI-0122-CSP-001
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

Brief Summary

Post-stroke shoulder pain is defined as pain in the shoulder area that starts after a person has had a stroke. The SPR System is an investigational device that is being studied for the relief of post-stroke shoulder pain. The SPR System uses electrical stimulation and includes a Trial Stage (where a temporary system is used to see if the subject may benefit from this type of therapy) and may include an Implant Stage (where a small device is implanted under the skin in the chest). The SPR System delivers mild electrical stimulation to the shoulder where the subject feels pain. This research study will evaluate the effect of electrical stimulation on shoulder pain. Individuals who are over the age of 21, who had a stroke at least six months ago, who experience shoulder pain, and have tried other therapies for their shoulder pain, may be eligible to participate in the first stage of the SPR System. Subjects meeting the specified success criteria at the conclusion of the SPR Trial Stage who experience a return of pain within 6 months of completion of the Trial Stage may be eligible for the second stage (SPR Implant Stage). This research study lasts a little over 3 years and may include 17 visits to the study doctor and at least 8 telephone calls from study staff.

Conditions

Shoulder Pain

Keywords

electrical stimulation; neurostimulation; neuromodulation; shoulder pain; post-stroke shoulder pain; hemiplegic shoulder pain

Outcome Measures

Primary Outcomes (5)

• Pain Intensity (Trial Stage)

  Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for Baseline, 3-weeks (End of Placebo), and 6-weeks (End of Treatment).

  Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

• Pain Intensity (Implant Stage)

  Subjects were asked to report their worst pain score on an 11-point numerical rating scale where 0 represents "No Pain" and 10 represents "Pain as bad as you can imagine." The average scores across subjects were reported for 3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON.

  3-weeks, 6-weeks, 12-weeks, 6-months, 9-months, 12-months, 24-months, and 36 months post IPG-Stim ON (Implant Stage)

• Device-Related Adverse Events

  At each study visit following the baseline assessment at Visit 1, subjects were questioned if any changes in their medical status or condition had occurred since their previous visit. If the subject experienced a change that was an adverse event, an Adverse Event Form was completed by the site. The number of subjects that experienced at least one study-related adverse event is reported here.

  Total of 86 months (from when the first subjects enrolled to when the last subject completed the study)

• Number of Subjects Who Were a Trial Stage Success

  The number of subjects who were a trial stage success is presented. Trial Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at the end of t.he Trial Stage beyond any placebo effect.

  End of Treatment (EOT)

• Number of Subjects Who Were an Implant Stage Success

  Number of subjects who were an Implant Stage Success is presented. Implant Stage Success for each subject was determined by a 2-point reduction in Brief Pain Inventory question 3 at 12-week post IPG stimulation ON beyond any placebo effect.

  12-weeks post IPG-Stim ON

Secondary Outcomes (14)

• Pain Interference (Trial Stage)

  Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

• Pain-Free Passive Range of Motion (Trial Stage)

  Baseline, 3-week (Trial Stage), 6-week (Trial Stage);

• Quality of Life (Trial Stage)

  Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

• Number of Participants Completing the Economic Impact Survey

  Baseline

• Emotional Functioning (Trial Stage)

  Baseline, 3-week (Trial Stage), 6-week (Trial Stage)

Study Arms (1)

The SPR System

EXPERIMENTAL

The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

Device: The SPR System

Interventions

The SPR System DEVICE

The SPR System is an investigational two-staged device which delivers stimulation to the shoulder. Subjects with chronic post-stroke shoulder pain who meet eligibility criteria for the first stage (SPR Trial Stage) will receive a temporary Lead and External Stimulator. Subjects who qualify and who agreed to proceed will advance to the second stage (SPR Implant Stage) which uses an Implantable Pulse Generator (IPG) and Implantable Lead. Subjects will be followed until 36-months after IPG stimulation has been started.

The SPR System

Eligibility Criteria

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

You may qualify if:

• At least 21 years of age
• Post-stroke shoulder pain

You may not qualify if:

• Use of habit-forming (narcotic) medications
• History of recurrent skin infections
• Bleeding disorder
• Parkinson's Disease, Spinal Cord Injury, traumatic brain injury, Multiple Sclerosis, or complex regional pain syndrome
• Heart arrhythmia or artificial heart valves
• Uncontrolled seizures
• Implanted Electronic Device
• Had a "return of pain" defined as an increase in pain of at least 2 points compared to the pain intensity score at Visit 5 and has a pain intensity score of at least 4

Sponsors & Collaborators

• SPR Therapeutics, Inc.: lead
• NDI Medical, LLC: collaborator

Study Sites (4)

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

Carolinas Healthcare System/Carolinas Rehabilitation

Charlotte, North Carolina, 28203, United States

Location

MetroHealth Medical Center

Cleveland, Ohio, 44109, United States

Location

Moss Rehab/ Albert Einstein Healthcare Network

Elkins Park, Pennsylvania, 19027, United States

Location

Related Publications (1)

• Nguyen VQ, Bock WC, Groves CC, Whitney M, Bennett ME, Lechman TE, Strother R, Grill JH, Stager KW, Chae J. Fully implantable peripheral nerve stimulation for the treatment of hemiplegic shoulder pain: a case report. Am J Phys Med Rehabil. 2015 Feb;94(2):146-53. doi: 10.1097/PHM.0000000000000173.

  PMID: 25251248 RESULT

MeSH Terms

Conditions

Shoulder Pain

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Affairs
• Organization: SPRTherapeutics

support@SPRTherapeutics.com

216-378-9108

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2010
• First Posted: March 26, 2010
• Study Start: April 1, 2010
• Primary Completion: July 25, 2017
• Study Completion: July 25, 2017
• Last Updated: September 12, 2018
• Results First Posted: September 12, 2018

Record last verified: 2018-09

Locations

US (4)