search
Back to results

Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Primary Purpose

Heart Diseases, Pain

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
heat-pack with massage
heat-pack only
Sponsored by
St. Olavs Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Diseases focused on measuring thorax, Intercostal Muscles, massage, heat-pack, hot temperature

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • increasing chest pain during a cardiac rehabilitation class
  • stable coronary disease
  • new re-vascularisation is not planned

Exclusion Criteria:

  • unstable coronary disease
  • not able to perform the study
  • abuse of drugs or alcohol
  • participating in other ongoing study

Sites / Locations

  • St Olavs University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

heat-pack with massage

heatpack only

Arm Description

deep friction massage and standard heat-pack given a maximum of 8 treatments

standard heat-pack given a maximum of 8 treatments

Outcomes

Primary Outcome Measures

pain
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains

Secondary Outcome Measures

quality of life
Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36

Full Information

First Posted
February 28, 2013
Last Updated
January 18, 2016
Sponsor
St. Olavs Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT01803529
Brief Title
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Official Title
Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
October 2003 (undefined)
Primary Completion Date
September 2008 (Actual)
Study Completion Date
October 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
St. Olavs Hospital

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Studies show that chest pain is a common complaint presented in both general practice and in emergency units. Musculoskeletal causes are common, but frequently overlooked. No studies about treatment of chest pain from the intercostal muscles were found by search in medical literature databases. The purpose of this study is to evaluate the effect of two different physical therapy interventions on intercostal pain in patients with stable heart disease. The hypothesis was that deep friction massage combined with heat-pack is more effective than heat-pack only.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Diseases, Pain
Keywords
thorax, Intercostal Muscles, massage, heat-pack, hot temperature

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
29 (Actual)

8. Arms, Groups, and Interventions

Arm Title
heat-pack with massage
Arm Type
Experimental
Arm Description
deep friction massage and standard heat-pack given a maximum of 8 treatments
Arm Title
heatpack only
Arm Type
Active Comparator
Arm Description
standard heat-pack given a maximum of 8 treatments
Intervention Type
Other
Intervention Name(s)
heat-pack with massage
Intervention Type
Other
Intervention Name(s)
heat-pack only
Primary Outcome Measure Information:
Title
pain
Description
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains
Time Frame
3 months
Secondary Outcome Measure Information:
Title
quality of life
Description
Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: increasing chest pain during a cardiac rehabilitation class stable coronary disease new re-vascularisation is not planned Exclusion Criteria: unstable coronary disease not able to perform the study abuse of drugs or alcohol participating in other ongoing study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stig A Slørdahl, md prof
Organizational Affiliation
St Olavs University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
St Olavs University Hospital
City
Trondheim
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
26770781
Citation
Berg AT, Stafne SN, Hiller A, Slordahl SA, Aamot IL. Physical therapy intervention in patients with non-cardiac chest pain following a recent cardiac event: A randomized controlled trial. SAGE Open Med. 2015 Apr 16;3:2050312115580799. doi: 10.1177/2050312115580799. eCollection 2015.
Results Reference
result

Learn more about this trial

Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

We'll reach out to this number within 24 hrs