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CompletedNCT00057148Updated Apr 7, 2015

Massage After Surgery To Help Treat Post-Operative Pain

An interventional study of massage treatment in Postoperative Pain, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-04-07.

Sponsored by US Department of Veterans Affairs · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Postoperative Pain

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Keywords

  • massage therapy
  • pain management
  • post-surgical
  • complementary therapy
03

In context

Pain, Postoperative

5,093 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

This study's planned enrollment of 300 is above the median of 75 across 4,344 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

US Department of Veterans Affairs is the lead sponsor of 658 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    Arm 1

    Procedure: massage treatment

Interventions

  • Proceduremassage treatment
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Anxiety, activity levels, function

07

Study locations

1 site
  • VA Ann Arbor Healthcare System, Ann Arbor, MI
    Ann Arbor, Michigan 48105, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 7, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00057148
Lead sponsor
US Department of Veterans Affairs
Responsible party
Sponsor
First posted
Mar 28, 2003
Start date
Feb 2003
Completion
Jun 2005
Last update
Apr 7, 2015

Study contacts

Daniel B. Hinshaw, MD
principal investigator · VA Ann Arbor Healthcare System, Ann Arbor, MI
Dolores F. Cikrit, MD
principal investigator · Richard L. Roudebush VA Medical Center, Indianapolis, IN

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2006. You cannot join it, but the record below documents what was studied.

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