Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

St. Olavs Hospital

ClinicalTrials.gov Identifier:

NCT01803529

First received: February 28, 2013

Last updated: January 18, 2016

Last verified: January 2016

History of Changes

Purpose

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.

Condition	Intervention
Heart Diseases Pain	Other: heat-pack with massage Other: heat-pack only


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Resource links provided by NLM:

MedlinePlus related topics: Heart Diseases

U.S. FDA Resources

Further study details as provided by St. Olavs Hospital:

Primary Outcome Measures:

pain [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains

Secondary Outcome Measures:

quality of life [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36


Enrollment:	29
Study Start Date:	October 2003
Study Completion Date:	October 2009
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: heat-pack with massage deep friction massage and standard heat-pack given a maximum of 8 treatments	Other: heat-pack with massage
Active Comparator: heatpack only standard heat-pack given a maximum of 8 treatments	Other: heat-pack only

Eligibility


Ages Eligible for Study:	18 Years to 80 Years (Adult, Senior)
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01803529

Locations


Norway
St Olavs University Hospital
Trondheim, Norway

Sponsors and Collaborators

St. Olavs Hospital

Investigators


Study Director:	Stig A Slørdahl, md prof	St Olavs University Hospital

More Information

Publications:

Berg AT, Stafne SN, Hiller A, Slørdahl 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.


Responsible Party:	St. Olavs Hospital
ClinicalTrials.gov Identifier:	NCT01803529 History of Changes
Other Study ID Numbers:	066-03
Study First Received:	February 28, 2013
Last Updated:	January 18, 2016
Health Authority:	Norway:National Committee for Medical and Health Research Ethics

Keywords provided by St. Olavs Hospital:


thorax Intercostal Muscles massage heat-pack hot temperature

Additional relevant MeSH terms:


Heart Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 27, 2016

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