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Therapeutic Massage to Manage Withdrawal Related Anxiety

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00992979
Recruitment Status : Completed
First Posted : October 9, 2009
Last Update Posted : October 9, 2009
Holistic Health Research Foundation of Canada
Information provided by:
Dalhousie University

Brief Summary:

In Canada, Addiction Prevention and Treatment Service's (APTS) offer programs specifically designed to help people withdrawal from psychoactive drugs. While participants of withdrawal management (Detox) programs generally reach their goals, the process is a difficult one often exacting an emotional and physical toll. Troublesome symptoms of withdrawal from psychoactive drugs may include anxiety and sleep disturbances. If untreated these symptoms can lead to discontinuation of withdrawal and /or affect the introduction of cognitive-behavioral and or motivational therapy components of Detox programs. In Detox the symptoms of withdraw are managed pharmacologically. Pharmacological tools for managing anxiety and sleep disturbances exist and while effective and safe, in many clinical settings, have limitations and liability in the addiction treatment setting. To address these concerns APTS has incorporated non-pharmacological anxiety management practices into its programs. Prominent among these is therapeutic massage (chair massage in the Swedish tradition). While therapeutic massage has been shown to reduce state and trait anxiety in a variety of clinical settings, no previous study has assessed its anxiolytic or sleep promoting efficacy in an addiction treatment setting. In keeping with ATPS's policy on evidence-based practice, evidence in support of this practice is now required.

Research Objectives: We propose to test the Hypothesis: Therapeutic Massage is an effective therapy for managing withdrawal-related anxiety and for improving sleep effectiveness in patients withdrawing from psychoactive drugs. Our specific objective is to perform a randomized controlled trial (RCT) to determine whether therapeutic massage is effective in comparison to relaxation control treatment in reducing the levels of state and trait anxiety associated with withdrawal and in promoting sleep efficiency.

Research Design: A RCT of the effects of therapeutic massage will be conducted on 80 patients (ages 18-65) attending an APTS Detox program. Patients will be assigned to 1 of 2 treatment groups (n=40/group) and will receive either: therapeutic massage or relaxation control treatment once a day for 3 consecutive days. Anxiety, state and trait, will be measured pre and post each treatment through a standardized tool and physiologic measures (heart rate & blood pre(state and trait) and sleep efficiency will be determined through actigraphy and daily sleep logs.

Condition or disease Intervention/treatment Phase
Substance Withdrawal Syndrome Drug Withdrawal Symptoms Anxiety Procedure: Therapeutic Massage Procedure: Relaxation Control Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Use of Massage Therapy to Reduce Anxiety and Improve Sleep in Patients Participating in an Inpatient Withdrawal Management (Detox) Program: A Randomized Controlled Pilot Study
Study Start Date : June 2008
Actual Primary Completion Date : January 2009
Actual Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arm Intervention/treatment
Experimental: Therapeutic Massage Procedure: Therapeutic Massage
Massage therapists with at least 5 years experience will perform the massages. On each of three consecutive days, participants (while fully clothed and in a seated position) will receive a 20-minute back, shoulder, neck and head massage. Subjects will be treated with conventional light pressure Swedish massage techniques which consisted of continuous systematic strokes including kneading and stretching to loosen and rehabilitate the soft tissues of the body and to provide general relaxation. The manual techniques include: effleurage , soothing petrissage , repetitive stroking, rocking , squeezing and mild joint mobilization. As is standard practice in massage therapy delivery, room lights will be dimmed and soft, soothing music played to enhance relaxation during therapy.
Other Name: Massage

Active Comparator: Relaxation Control
Relaxation Control Session
Procedure: Relaxation Control
On each of three consecutive evenings, subjects in this group will participate in a 20 minute relaxation session. This session will be delivered in the same location and with the same lighting and music as with the therapeutic massage group. Each participant will be asked to choose a comfortable position in a chair and a massage therapist will sit quietly in the room approximately 4 feet behind the participant.
Other Name: Relaxation

Primary Outcome Measures :
  1. State and Trait Anxiety (Spielberger State Trait Anxiety Inventory of Adults (Y1 and Y2)) [ Time Frame: State and trait anxiety scores will be determined at baseline (at the time of recruitment into the study) and then immediately prior to and within 10 minutes following each intervention session (pre/post design) ]

Secondary Outcome Measures :
  1. Heart Rate and Blood Pressure [ Time Frame: Heart rate and blood pressure will be measured at baseline (at the time of recruitment into the study) and then immediately prior to and within 10 minutes following each intervention session (pre/post design) ]
  2. Sleep Quality [ Time Frame: On each intervention day subjects will wear an actigraph during normal sleep time. They will also be asked to complete a sleep log in the morning, upon waking for each post-intervention day ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Individuals receiving inpatient treatment for withdrawal from psychoactive drugs and who were able to give informed consent and comply with study procedures were eligible to participate.
  • being at least 18 years of age;
  • self-reported primary presenting problem as one of the following: alcohol, cocaine, or opioids

Exclusion Criteria:

  • prior treatment or experience with massage therapy
  • prior history of anxiety or sleep disorder
  • history of coagulation or platelet disorders or be currently taking medications that may promote bleeding
  • contraindications to the treatment intervention as described in the standards of care of the College of Massage Therapists of Ontario (

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00992979

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Canada, Nova Scotia
Addiction Prevention and Treatment Services; Capital District
Halifax, Nova Scotia, Canada, B2Y 3Z6
Sponsors and Collaborators
Dalhousie University
Holistic Health Research Foundation of Canada
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Principal Investigator: Robert W Gilbert, PhD Dalhousie University
Study Director: Shaun Black, MSc Capital District Health Authority, Addiction Prevention and Treatment Services
Study Director: Kathleen Jacques, PhD, RMT Canadian College of Massage and Hydrotherapy

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Responsible Party: Robert William Gilbert, School of Health Sciences, Dalhousie University Identifier: NCT00992979    
Other Study ID Numbers: DAL09-01
HHRFC #2007-06
First Posted: October 9, 2009    Key Record Dates
Last Update Posted: October 9, 2009
Last Verified: January 2009
Keywords provided by Dalhousie University:
Psychoactive Drugs
Therapeutic Massage
Additional relevant MeSH terms:
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Substance Withdrawal Syndrome
Anxiety Disorders
Mental Disorders
Substance-Related Disorders
Chemically-Induced Disorders