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Postoperative PainNCT00057148

Massage After Surgery To Help Treat Post-Operative Pain

A study testing massage treatment in people with Postoperative Pain, run by US Department of Veterans Affairs at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Postoperative Pain
What is being tested?
massage treatment
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
300 participants
Where
1 siteUnited States
Study dates
Feb 2003to Jun 2005
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Ann Arbor Healthcare System, Ann Arbor, MI

    Ann Arbor, Michigan, 48105

Other trials in United States

About this study

Official title: Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy

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).

Being tested
massage treatment
Keywords
massage therapy, pain management, post-surgical, complementary therapy
Medical subject headings
Pain, Postoperative, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • massage treatmentProcedure or surgery

Study groups in NCT00057148
Study groupRoleWhat they receive
Arm 1OtherNot described
Receives: Procedure: massage treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Secondary outcomes (1)
  1. Anxiety, activity levels, function

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Mar 2003 (estimated)
  2. Study startFeb 2003
  3. Study completionJun 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
300 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00057148
Sponsor's protocol ID
IIR 01-197
Status last verified
Mar 2006
First submitted
27 Mar 2003
Last updated
7 Apr 2015
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing massage treatment in people with Postoperative Pain, run by US Department of Veterans Affairs at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Post-operative pain intensity and pain unpleasantness over 5 days post-surgery. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.

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