Group Versus Individual Acupuncture for Cancer Pain

Pain Clinical Trial

Official title:

A Non-Inferiority Randomized Controlled Trial Comparing Community (Group) Acupuncture to Individual Acupuncture to Alleviate Cancer Pain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641222
• Other study ID #: HREBA.CC-17-0237
• Status: Completed
• Phase: N/A
• Start date: October 2, 2017
• Est. completion date: September 30, 2018

Study information

• Verified date: March 2019
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Cancer patients, post-treatments were given acupuncture treatments to help alleviate pain, in a two-arm randomized trial.

Description:

Typically, in North America, acupuncture is performed on an individual basis. However, community acupuncture, also known as group acupuncture, is an emerging method of treating patients. Although the practice can vary, community acupuncture is performed in a group setting, typically with reclining chairs dispersed around a large room, and one practitioner treating up to six people per session.

The outcomes of this this randomized controlled trial will allow the researchers to assess whether group acupuncture is a viable treatment option for people with cancer who are suffering from pain, especially those who are either resistant to or looking to avoid the side effects of opioids.

Objectives Examine the efficacy of community acupuncture for alleviating cancer pain, fatigue, sleep disturbances and distress when compared to individual acupuncture.

Evaluate the cost-effectiveness of community acupuncture compared to individual acupuncture.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: September 30, 2018
• Est. primary completion date: August 30, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Adult cancer patients (=18 years old), both male and female.

2. Experiencing pain with a minimum worst pain score (in the previous week) =3 on the 10-point Brief Pain Inventory (BPI).

3. All tumor groups, including metastatic patients.

4. Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.

5. Must be willing to be randomized into either group, and must be able to attend a minimum of nine treatment sessions within a six-week period.

Exclusion Criteria:

1. Use of acupuncture within the previous six months.

2. Currently on or within one-month of active treatment (chemotherapy or radiation).

Related Conditions & MeSH terms

• Cancer
• Cancer Pain
• Pain

Intervention

Device:
• Acupuncture
Traditional Chinese Medicine (TCM) Acupuncture

Locations

Country	Name	City	State
Canada	Psychosocial Oncology, Cancer Control Alberta	Calgary	Alberta

Sponsors (1)

Lead Sponsor	Collaborator
University of Calgary

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Brief Pain Inventory—Short Form	The Brief Pain Inventory—Short Form (BPISF) is a widely used self-report measure, originally developed for cancer pain, which measures both pain severity and pain interference	6 weeks
Secondary	The Profile of Mood States—Short Form	The Profile of Mood States—Short Form (POMS-SF) is a validated measure of psychological distress, which calculates Total Mood Disturbance (TMD) using six subscales: fatigue, vigor, tension, depression, anger and confusion (Shacham, 1983). The 37-item questionnaire asks patients to rate how various adjectives relate to how they have felt in the past week, on a Likert scale from zero (not at all) to four (extremely).	6 weeks
Secondary	Pittsburg Sleep Quality Index	The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances	6 weeks
Secondary	The Functional Assessment of Cancer Therapy-General	The Functional Assessment of Cancer Therapy—General (FACT-G) is a 20-item questionnaire that measures health-related quality of life (HRQOL) within the cancer population. The questionnaire contains four subscales: physical, social/family, emotional and functional well-being.	6 weeks
Secondary	The Functional Assessment of Cancer Therapy - Fatigue	The Functional Assessment of Cancer Therapy—Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue	6 weeks
Secondary	The Inventory of Socially Supportive Behaviours	The Inventory of Socially Supportive Behaviours (ISSB) Short Form is an 18-item questionnaire designed to measure social support, which asks participants to indicate the number of times they have experienced particular behaviours in the past month	6 weeks
Secondary	Edmonton Symptom Assessment Scale	The Edmonton Symptom Assessment Scale (ESAS) is a simple screening measure that can be used to assess various physical and psychological symptoms, originally designed for palliative care patients	6 weeks
Secondary	A Pain Visual Analog Scale	The pain visual analog scale (VAS) consists of a 10 centimetre line on a slip of white paper, with the indicators "no pain at all" on the far-left end, and "worst pain imaginable" on the far-right end	6 weeks
Secondary	The European Quality of Life-5 Dimensions	This utility scoring instrument is intended to provide an overall quality of life evaluation with a scale from 1 (perfect health) to 0 (death) and allows for the calculation of quality adjusted life years (QALYs)	6 weeks