Study to Determine Therapeutic Massage Dosing to Improve Quality of Life in Hospitalized Patients Receiving Palliative Care

NCT04916223 | Completed

• 1 other identifier: 2017-260
• Study Type: interventional
• Target: 405
• Locations: 1 country
• Sites: 1

Brief Summary

Therapeutic massage is the most common non-traditional treatment option offered to improve quality of life, provide comfort and decrease pain in hospice and palliative care settings outside the hospital. Three systematic reviews of data in general pain, surgical and cancer populations found massage to be effective for treating pain versus active comparators. Given the remarkable negative impact on QOL experienced by patients hospitalized with a serious progressive illness, a nationwide opioid crisis in the setting of public concern for untreated pain, and patient demand for integrative therapies, we wish to investigate non-traditional methods of supporting patients in pain and providing clinicians with viable alternatives. Unfortunately, very little is known about optimal delivery of massage interventions in the hospital setting, including dosing parameters such as time and frequency We conducted a single center comparative effectiveness study to evaluate therapeutic massage "dosing" to improve self-reported quality-of-life in hospitalized patients receiving palliative care consultation.

Conditions

Cancer; Heart Failure; COPD; Sepsis; HIV Infections; ESRD; Trauma; Stroke

Outcome Measures

Primary Outcomes (1)

• Change from baseline to post-intervention in McGill Quality of Life Questionnaire Single Item

  The McGill QOL Questionnaire is a validated reliable tool to evaluate self-reported QOL. One item in the Questionnaire has been shown to effectively assess subject's self-reported QOL.

  Baseline and one day post intervention

Secondary Outcomes (4)

• Change from baseline to post-intervention in Edmonton Symptom Assessment Scale

  Baseline and one day post intervention

• Change from baseline to post-intervention in National Comprehensive Cancer Network Distress Thermometer

  Baseline and one day post intervention

• Change from baseline to post-intervention in Peace Questionnaire

  Baseline and one day post intervention

• Satisfaction with assigned intervention

  One day post intervention

Study Arms (3)

3 x 10-minute massage

EXPERIMENTAL

Subject receives a 10-minute massage daily for three consecutive days

Other: Therapeutic massage

3 x 20-minute massage

EXPERIMENTAL

Subject receives a 20-minute massage daily for three consecutive days

Other: Therapeutic massage

Single 20-minute massage

ACTIVE COMPARATOR

Subject receives one 20-minute massage

Other: Therapeutic massage

Interventions

Therapeutic massage OTHER

The massage therapists were scheduled on a rotating schedule with two alternates scheduled for each day to ensure adherence to assigned study arm and to avoid "therapist effect" as much as possible. For each enrolled subject, the therapist assessed the subject and created a treatment plan depending on his/her individual needs and preferences. For example, if a subject reported bothersome lower extremity pain, the therapist might focus the massage on that lower extremity or might avoid massaging that lower extremity, depending solely on the preference of the subject. Massage duration was determined by the assigned study arm.

3 x 10-minute massage; 3 x 20-minute massage; Single 20-minute massage

Eligibility Criteria

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

You may qualify if:

• age 18 and older
• hospitalized, receiving inpatient palliative care consultation for any indication

You may not qualify if:

• unable to complete surveys in English
• on negative-pressure isolation
• unstable spine
• platelets \< 10,000
• received massage in last 30 days

Sponsors & Collaborators

• Medstar Health Research Institute: lead

Study Sites (1)

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

MeSH Terms

Conditions

Neoplasms; Heart Failure; Pulmonary Disease, Chronic Obstructive; Sepsis; HIV Infections; Kidney Failure, Chronic; Wounds and Injuries; Stroke

Interventions

Massage

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Blood-Borne Infections; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Male Urogenital Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Therapy, Soft Tissue; Musculoskeletal Manipulations; Complementary Therapies; Therapeutics; Physical Therapy Modalities; Rehabilitation

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 1, 2021
• First Posted: June 7, 2021
• Study Start: November 1, 2017
• Primary Completion: March 26, 2019
• Study Completion: March 26, 2019
• Last Updated: December 13, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)