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Group Versus Individual Acupuncture for Cancer Pain

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03641222
Enrollment
76
Registered
2018-08-21
Start date
2017-10-02
Completion date
2018-09-30
Last updated
2019-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer, Pain

Keywords

Acupuncture, Group, Community Based, Individual, Randomized

Brief 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.

Detailed 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.

Interventions

DEVICEAcupuncture

Traditional Chinese Medicine (TCM) Acupuncture

Sponsors

University of Calgary
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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).

Design outcomes

Primary

MeasureTime frameDescription
The Brief Pain Inventory-Short Form6 weeksThe 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

Secondary

MeasureTime frameDescription
The Functional Assessment of Cancer Therapy-General6 weeksThe 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.
The Profile of Mood States-Short Form6 weeksThe 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).
Pittsburg Sleep Quality Index6 weeksThe Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances
The Functional Assessment of Cancer Therapy - Fatigue6 weeksThe Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue
The Inventory of Socially Supportive Behaviours6 weeksThe 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
Edmonton Symptom Assessment Scale6 weeksThe 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
A Pain Visual Analog Scale6 weeksThe 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
The European Quality of Life-5 Dimensions6 weeksThis 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)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026