NCT00057148

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable postoperative-pain

Timeline
Completed

Started Feb 2003

Longer than P75 for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2003

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 27, 2003

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 28, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
Last Updated

April 7, 2015

Status Verified

March 1, 2006

First QC Date

March 27, 2003

Last Update Submit

April 6, 2015

Conditions

Postoperative Pain

Keywords

massage therapypain managementpost-surgicalcomplementary therapy

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (1)

  • Anxiety, activity levels, function

Study Arms (1)

Arm 1

OTHER
Procedure: massage treatment

Interventions

massage treatmentPROCEDURE
Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Veterans undergoing major surgery with an incision that is greater than or equal to 8 cm in length

You may not qualify if:

  • Blindness, rash or skin lesions on the back, unable to read, florid psychosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Study Officials

  • Daniel B. Hinshaw, MD

    VA Ann Arbor Healthcare System, Ann Arbor, MI

    PRINCIPAL INVESTIGATOR

  • Dolores F. Cikrit, MD

    Richard L. Roudebush VA Medical Center, Indianapolis, IN

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 27, 2003

First Posted

March 28, 2003

Study Start

February 1, 2003

Study Completion

June 1, 2005

Last Updated

April 7, 2015

Record last verified: 2006-03

Locations

US(1)