Massage After Surgery To Help Treat Post-Operative Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Department of Veterans Affairs
ClinicalTrials.gov Identifier:
NCT00057148
First received: March 27, 2003
Last updated: February 6, 2014
Last verified: March 2006
  Purpose

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.


Condition Intervention
Postoperative Pain
Procedure: massage treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy

Further study details as provided by Department of Veterans Affairs:

Primary Outcome Measures:
  • Post-operative pain intensity and pain unpleasantness over 5 days post-surgery [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Anxiety, activity levels, function [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: February 2003
Study Completion Date: June 2005
Arms Assigned Interventions
Arm 1 Procedure: massage treatment

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00057148

Locations
United States, Michigan
VA Ann Arbor Healthcare System
Ann Arbor, Michigan, United States, 48113-0170
Sponsors and Collaborators
Investigators
Principal Investigator: Daniel B. Hinshaw, MD VA Ann Arbor Healthcare System
Principal Investigator: Dolores F. Cikrit, MD Richard Roudebush VA Medical Center
  More Information

No publications provided

Responsible Party: Department of Veterans Affairs
ClinicalTrials.gov Identifier: NCT00057148     History of Changes
Other Study ID Numbers: IIR 01-197
Study First Received: March 27, 2003
Last Updated: February 6, 2014
Health Authority: United States: Federal Government

Keywords provided by Department of Veterans Affairs:
massage therapy
pain management
post-surgical
complementary therapy

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014