Ignite Creation Date:
2024-05-05 @ 11:29 AM
Last Modification Date:
2024-10-26 @ 9:08 AM
Study NCT ID:
NCT00057148
Status:
COMPLETED
Last Update Posted:
2015-04-07
First Post:
2003-03-27
Brief Title:
Massage After Surgery To Help Treat Post-Operative Pain
Sponsor:
US Department of Veterans Affairs
Organization:
VA Office of Research and Development
Study Overview
Official Title:
Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy
Status:
COMPLETED
Status Verified Date:
2006-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
OBJECTIVES
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 prepost 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
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
OBJECTIVES
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 prepost 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None