- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01803529
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Trondheim, Norway
- St Olavs University Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: heat-pack with massage
deep friction massage and standard heat-pack given a maximum of 8 treatments
|
|
Active Comparator: heatpack only
standard heat-pack given a maximum of 8 treatments
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
pain
Time Frame: 3 months
|
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
quality of life
Time Frame: 3 months
|
Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Stig A Slørdahl, md prof, St Olavs University Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 066-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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