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NCT01803529 Clinical Trial

Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Pain Clinical Trial

Official title:
Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01803529
Other study ID # 066-03
Secondary ID
Status Completed
Phase N/A
First received February 28, 2013
Last updated January 18, 2016
Start date October 2003
Est. completion date October 2009

Study information
Verified date January 2016
Source St. Olavs Hospital
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research Ethics
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 29
Est. completion date October 2009
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• heat-pack with massage

• heat-pack only

Locations
Country Name City State
Norway St Olavs University Hospital Trondheim

Sponsors (1)
Lead Sponsor Collaborator
St. Olavs Hospital

Country where clinical trial is conducted

Norway, 

References & Publications (1)

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: 10.1177/2050312 — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary pain Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains 3 months No
Secondary quality of life Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36 3 months No
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