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Resteck Shiatsu Neck and Back Massager for Shoulder Pain
Phase 4
Waitlist Available
Led By Sumeet K Mittal, MD
Research Sponsored by Norton Thoracic Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial found that the addition of a back massager to standard pain medication significantly reduces shoulder pain after laparoscopic hernia surgery.
Eligible Conditions
- Shoulder Pain
- Hiatal Hernia
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Opioid and Non-Opioid Usage Postoperative Period
Visual Analogue Score Pain Questionnaire
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: Back Massager Device + Standard Pain TreatmentExperimental Treatment1 Intervention
Resteck Shiatsu Neck and Back Massager (brand name), with recommended use for at least every 2 hours for at least 15 minutes on the first post-operative day and then every 4 hours for 2 days and then as needed.
Standard pain treatment:
Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc)
Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth
Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed
Tylenol 650 mg Tab: oral administration every 6 hours
Group II: Standard Pain TreatmentActive Control1 Intervention
will receive standard pain treatment include local anesthetic agent at the incision sites + oral Tylenol and oral or IV opioid as breakthrough pain treatment postoperatively as needed.
Standard pain treatment:
Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc)
Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth
Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed
Tylenol 650 mg Tab: oral administration every 6 hours
Group III: Marcaine spray + Standard Pain TreatmentActive Control1 Intervention
30cc of 0.25% Marcaine spray on the diaphragm at the end of surgery.
Standard pain treatment:
Local anesthetic agent at the incision sites include: 0.5% Marcaine (10 cc) + 0.5% lidocaine and epinephrine (10 cc) (total volume: 20 cc)
Morphine 2 mg: Intravenous administration every 2 hours or as needed, if unable to take pills by mouth
Oxycodone 5 - 10 mg elixir: oral administration every 6 hours or as needed
Tylenol 650 mg Tab: oral administration every 6 hours
Find a Location
Who is running the clinical trial?
Norton Thoracic InstituteLead Sponsor
Sumeet K Mittal, MDPrincipal InvestigatorSt. Joseph's Hospital and Medical Center, Norton Thoracic Institute
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