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Massage After Surgery To Help Treat Post-Operative Pain

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
massage treatment
Sponsored by
US Department of Veterans Affairs
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring massage therapy, pain management, post-surgical, complementary therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Veterans undergoing major surgery with an incision that is greater than or equal to 8 cm in length Exclusion Criteria: Blindness, rash or skin lesions on the back, unable to read, florid psychosis

Sites / Locations

  • VA Ann Arbor Healthcare System, Ann Arbor, MI

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Arm 1

Arm Description

Outcomes

Primary Outcome Measures

Post-operative pain intensity and pain unpleasantness over 5 days post-surgery

Secondary Outcome Measures

Anxiety, activity levels, function

Full Information

First Posted
March 27, 2003
Last Updated
April 6, 2015
Sponsor
US Department of Veterans Affairs
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1. Study Identification

Unique Protocol Identification Number
NCT00057148
Brief Title
Massage After Surgery To Help Treat Post-Operative Pain
Official Title
Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
March 2006
Overall Recruitment Status
Completed
Study Start Date
February 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
US Department of Veterans Affairs

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Postoperative pain is often undertreated. Although studies have demonstrated that many patients experience a substantial degree of unrelieved pain following operative procedures and that this pain can increase the incidence of serious complications, the management of discomfort continues to be suboptimal. Narcotic analgesia is the mainstay of acute postoperative pain management but patient, clinician, and institutional barriers often limit the effectiveness of drug treatment. Furthermore, pharmacologic interventions alone may not address all the factors involved in the conscious experience of pain. Massage is a complementary or adjunctive medical technique that has been used for thousands of years. Yet there is scant research related to the use of massage therapy in postoperative pain management. Used in tandem with pharmacologic treatments, massage may have the potential to substantially improve acute pain relief.
Detailed Description
BACKGROUND / RATIONALE: Postoperative pain is often undertreated. Although studies have demonstrated that many patients experience a substantial degree of unrelieved pain following operative procedures and that this pain can increase the incidence of serious complications, the management of discomfort continues to be suboptimal. Narcotic analgesia is the mainstay of acute postoperative pain management but patient, clinician, and institutional barriers often limit the effectiveness of drug treatment. Furthermore, pharmacologic interventions alone may not address all the factors involved in the conscious experience of pain. Massage is a complementary or adjunctive medical technique that has been used for thousands of years. Yet there is scant research related to the use of massage therapy in postoperative pain management. Used in tandem with pharmacologic treatments, massage may have the potential to substantially improve acute pain relief. OBJECTIVE(S): The proposed research will test the hypotheses that: 1) perceived post-operative pain and anxiety decrease over time (5 days) more rapidly in the massage group compared with the focused attention and routine care groups; 2) perceived post-operative pain and anxiety are immediately reduced in the massage group compared with the focused attention and routine care groups. (differences in pre/post daily scores); 3) post-operative complication rate is reduced and function is improved by the adjuvant use of massage compared to the control groups; 4) the adjuvant use of massage reduces postoperative length of stay and cost of care; and 5) patient satisfaction with postoperative pain relief is enhanced by the adjuvant use of massage. METHODS: The study is a prospective, randomized clinical trial conducted at the Ann Arbor and Indianapolis VA medical centers. Patients undergoing operative procedures involving either a sternotomy or an abdominal incision at least 8 cm in length will be randomly assigned to one of three parallel treatment groups: 1) routine postoperative care, 2) focused attention where a massage therapist spends dedicated time (but no massage is given) with the patient once a day (20 min) during post-operative days 1 through 5; or 3) effleurage massage (20 min) performed by a massage therapist once per day on post-op days 1 through 5. The anticipated sample size is 582 patients. Postoperatively patients will be asked to rate their intensity of pain, well-being, function (ability to cough, deep breathe, sleep and activity level) daily for up to five days (less if discharged prior to day five). Data will be collected on all aspects of narcotic analgesia use including the name of each drug, dose, route, and time of administration. On day six patients will complete a survey to assess their satisfaction with pain management. Using the Department of Veterans Affairs National Surgical Quality Improvement Program (NSQIP) format, data will be collected on postoperative complications during the first 30 days after the procedure. Other factors relevant to the veteran population that may affect pain control will be assessed in relationship to pain management. STATUS: This study began in September 2002. We are currently in the data analysis phase of the project and plan to be finished by December, 2005. IMPACT: Although pharmacologic agents have the ability to effectively limit pain, acute postoperative pain is often poorly managed with analgesic drugs alone. This study will be the first large-scale randomized clinical trial of massage as a complementary treatment in the management of acute postoperative pain. This study will help to determine if massage can serve as a useful adjuvant therapy in the management of acute postoperative incisional pain. Results from this study would inform pain management guidelines and allow the VA and the scientific community to make informed decisions regarding the potential benefits of one form of CAM (Complimentary and Alternative Medicine).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
massage therapy, pain management, post-surgical, complementary therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Other
Intervention Type
Procedure
Intervention Name(s)
massage treatment
Primary Outcome Measure Information:
Title
Post-operative pain intensity and pain unpleasantness over 5 days post-surgery
Secondary Outcome Measure Information:
Title
Anxiety, activity levels, function

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Veterans undergoing major surgery with an incision that is greater than or equal to 8 cm in length Exclusion Criteria: Blindness, rash or skin lesions on the back, unable to read, florid psychosis
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel B. Hinshaw, MD
Organizational Affiliation
VA Ann Arbor Healthcare System, Ann Arbor, MI
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dolores F. Cikrit, MD
Organizational Affiliation
Richard L. Roudebush VA Medical Center, Indianapolis, IN
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Ann Arbor Healthcare System, Ann Arbor, MI
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48105
Country
United States

12. IPD Sharing Statement

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Massage After Surgery To Help Treat Post-Operative Pain

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