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Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy - Article


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Clinical Trial: Acute Post-Operative Pain Management Using Massage As Adjuvant Therapy

This study is currently recruiting patients.

Sponsored by: Department of Veterans Affairs
Information provided by: Department of Veterans Affairs

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. 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. 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.

Condition Treatment or Intervention
Pain
 Procedure: massage treatment after surgery

MedlinePlus related topics:  Pain

Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Further Study Details: 

Expected Total Enrollment:  665

Study start: September 2002;  Expected completion: November 2005

Eligibility

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

  • Must be veterans undergoing surgery which involves greater than 8 cm incision.

Location and Contact Information


Indiana
      Richard Rodebush VA Medical Center, Indianapolis,  Indiana,  46202-2884,  United States; Recruiting
Dolores F. Cikrit, MD  317-554-0000  Ext. 2397    dolores.cikrit@med.va.gov 

More Information

Study ID Numbers:  IIR 01-197
Record last reviewed:  March 2005
Last Updated:  March 18, 2005
Record first received:  March 27, 2003
ClinicalTrials.gov Identifier:  NCT00057148
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 8, 2005


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