Acupuncture for Post-Thoracotomy Pain

NCT00142532 | Completed Phase 3

• 1 other identifier: 04-073
• Study Type: interventional
• Target: 162
• Locations: 1 country
• Sites: 1

Brief Summary

Pain after surgery for lung cancer (thoracotomy) may persist for years and require long-term analgesic use. Prior studies have shown that acupuncture reduces pain and medication use in the early post-operative period after abdominal surgery, suggesting that acupuncture may have a role in preventing chronic post-thoracotomy pain. This study is being done in order to determine the effects of acupuncture on pain in patients undergoing surgery for lung cancer.

Conditions

Lung Cancer; Pain

Keywords

Acupuncture; Pain; Lung Cancer; Thoracotomy; Surgery

Outcome Measures

Primary Outcomes (2)

• To determine whether acupuncture versus placebo acupuncture after thoracotomy reduces pain or analgesic use

  one year

• To determine whether acupuncture affects the immediate post-operative period and/or 30, 60, 90 days and approximately 12 months later

  one year

Study Arms (2)

1

EXPERIMENTAL

At the time of pre-op preparation, 18 semi-permanent intradermal acupuncture studs will be placed at acupuncture points in the back, two will be placed in the legs and two in the ear. All studs will be replaced when the epidural is removed or, for patients without epidurals, shortly before discharge. The new leg and auricular studs will then be removed at eleven days; the new back studs will be removed at the three week post-discharge consult.

Procedure: Acupuncture and Questionnaires

2

PLACEBO COMPARATOR

The treatment is the same as for the true acupuncture group, with the following exceptions. The studs in the back will be dummy studs have no needle and that have been used in previous research at MSKCC. The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (\~1.25cm) from the spine. The leg studs will be placed at 2 cun (\~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (\~ 5cm) proximal and 3 cun (\~ 5cm) medial to the midpoint of the antecubital crease. Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory

Procedure: Placebo Acupuncture, Questionnaires

Interventions

Acupuncture and Questionnaires PROCEDURE

Acupuncture 30 day treatment BL12 - 19 and extra point Wei Guan Xia Shu Each side of the spine,1.5 cun (\~2.5cm) lateral to the lower border of spinous process of the T2 - 10 spinal vertebrae respectively 4 weeks ST36, Below the knee, 3 cun (\~7.5cm) inferior to the lower border of the patella, one finger breadth lateral to the anterior crest of the tibia. One week following removal of epidural. Shenmen, bilaterally. At the lateral 1/3 of the triangular fossa in the auricle.One week following removal of epidural. Questionnaires 30 / 60 / 90 Day and 12 Month Follow-up-Numerical rating scale of pain; total opioid use; Medication Quantification Scale; length of stay; Brief Pain Inventory

1

Placebo Acupuncture, Questionnaires PROCEDURE

The back studs will be placed halfway between the upper and lower border of spinous processes T2 to T10, approximately 0.5 cun (\~1.25cm) from the spine. The leg studs will be placed at 2 cun (\~5cm) posterior to GB34 on the posterior of the lower leg. No studs will be placed in the ear; rather studs will be placed on the anterior arm, 3 cun (\~ 5cm) proximal and 3 cun (\~ 5cm) medial to the midpoint of the antecubital crease. Pain will be assessed by a 0 - 10 point numerical rating scale (NRS) marked "no pain" at one end and "worst pain" at the other.

2

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing unilateral thoracotomy at Memorial Sloan-Kettering Cancer Center (MSKCC)
• Age greater than or equal to 18 years old.

You may not qualify if:

• Any of the following procedures: hemiclamshell, clamshell, extrapleural approach, chest wall involvement, esophagectomy. These more extensive procedures have a higher risk of complications.
• Acupuncture treatment in the previous six weeks, to discount any persisting effect of acupuncture
• Platelets \< 20,000 or International Normalized Ratio (INR) \> 2.5 or absolute neutrophil count (ANC) \< 0.5; though it would be unusual for any patient to be operated on with such values, it seems wise as a precautionary measure to avoid risk of bleeding from acupuncture.
• Known cardiac conditions constituting a high or moderate risk of endocarditis as defined by the American Heart Association criteria
• Patients unable to remove studs without assistance, who have no home assistance, and who are unable or unwilling to return to the hospital in the event that they decide to remove studs before the post-discharge visit.

Sponsors & Collaborators

• Memorial Sloan Kettering Cancer Center: lead

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Links

• Memorial Sloan-Kettering Cancer Center

MeSH Terms

Conditions

Lung Neoplasms; Pain

Interventions

Acupuncture Therapy; Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Barrie Cassileth, PhD

  Memorial Sloan Kettering Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: June 1, 2005
• Primary Completion: January 1, 2008
• Study Completion: January 1, 2008
• Last Updated: January 14, 2009

Record last verified: 2009-01

Locations

US (1)