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Completed

NCT Number: NCT03641222

Group Versus Individual Acupuncture for Cancer Pain

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.

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Key information

Conditions

Cancer Neoplasms Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Psychosocial Oncology, Cancer Control Alberta

Calgary, Alberta, T2N 3C1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult cancer patients (≥18 years old), both male and female.
  • Experiencing pain with a minimum worst pain score (in the previous week) ≥3 on the 10-point Brief Pain Inventory (BPI).
  • All tumor groups, including metastatic patients.
  • Participant's pain can originate from any source, including postoperative, malignancy related, and neuropathic pain.
  • 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

  • Use of acupuncture within the previous six months.
  • Currently on or within one-month of active treatment (chemotherapy or radiation).

Treatment and study plan

acupuncture

Device

Traditional Chinese Medicine (TCM) Acupuncture

Primary outcomes

  1. The Brief Pain Inventory-Short Form

    Time frame: 6 weeks

    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

Secondary outcomes

  1. The Profile of Mood States-Short Form

    Time frame: 6 weeks

    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).

  2. Pittsburg Sleep Quality Index

    Time frame: 6 weeks

    The Pittsburg Sleep Quality Index (PSQI) is 19-item questionnaire that measures quality of sleep and sleep disturbances

  3. The Functional Assessment of Cancer Therapy-General

    Time frame: 6 weeks

    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.

  4. The Functional Assessment of Cancer Therapy - Fatigue

    Time frame: 6 weeks

    The Functional Assessment of Cancer Therapy-Fatigue (FACT-F) comprised of the FACT-G, plus an additional 13 questions related to fatigue

  5. The Inventory of Socially Supportive Behaviours

    Time frame: 6 weeks

    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. Edmonton Symptom Assessment Scale

    Time frame: 6 weeks

    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

  7. A Pain Visual Analog Scale

    Time frame: 6 weeks

    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

  8. The European Quality of Life-5 Dimensions

    Time frame: 6 weeks

    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)

Sponsors and collaborators

Lead sponsor

University of Calgary

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Aug 21, 2018
Registry last updated
Mar 18, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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