Heart DiseasesNCT01803529
Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
A study testing heat-pack with massage and heat-pack only in people with Heart Diseases and Pain, run by St. Olavs Hospital at 1 site in Norway.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Heart Diseases, Pain
- What is being tested?
- heat-pack with massage and heat-pack only
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteNorway
- Study dates
- Oct 2003to Oct 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- increasing chest pain during a cardiac rehabilitation class
- stable coronary disease
- new re-vascularisation is not planned
Who cannot join
- unstable coronary disease
- not able to perform the study
- abuse of drugs or alcohol
- participating in other ongoing study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Heart Diseases, Pain
- Being tested
- heat-pack with massage, heat-pack only
- Keywords
- thorax, Intercostal Muscles, massage, heat-pack, hot temperature
- Medical subject headings
- Heart Diseases, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
heat-pack with massageOther
heat-pack onlyOther
| Study group | Role | What they receive |
|---|---|---|
| heat-pack with massage | Experimental | deep friction massage and standard heat-pack given a maximum of 8 treatments Receives: Other: heat-pack with massage |
| heatpack only | Active comparator | standard heat-pack given a maximum of 8 treatments Receives: Other: heat-pack only |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains
Measured: 3 months
Secondary outcomes (1)
quality of life
Health-related Quality of life ( HRQL) was evaluated by the disease-specific instrument MacNew and the generic instrument SF-36
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2013 (estimated)
- Study startOct 2003
- Primary completionSep 2008
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart DiseasesStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stig A Slørdahl, md prof, Study director, St. Olavs Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01803529
- Sponsor's protocol ID
- 066-03
- Status last verified
- Jan 2016
- First submitted
- 28 Feb 2013
- Last updated
- 20 Jan 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26770781
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Standard Heat-pack With or Without Deep Friction Massage for Intercostal Pain in Patients With Heart Disease
- ClinicalTrials.gov ID
- NCT01803529
- Acronym / sponsor ID
- 066-03
- Conditions
- Heart Diseases, Pain
- Keywords
- thorax, Intercostal Muscles, massage, heat-pack, hot temperature
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Study start
- Oct 2003
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 4 Mar 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| heat-pack with massage | Experimental | Other: heat-pack with massagedeep friction massage and standard heat-pack given a maximum of 8 treatments |
| heatpack only | Active comparator | Other: heat-pack onlystandard heat-pack given a maximum of 8 treatments |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- increasing chest pain during a cardiac rehabilitation class
- stable coronary disease
- new re-vascularisation is not planned
Key exclusion criteria (4 listed)
- unstable coronary disease
- not able to perform the study
- abuse of drugs or alcohol
- participating in other ongoing study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| heat-pack with massage | Other | heat-pack with massage |
| heat-pack only | Other | heatpack only |
Primary outcome
pain
Time frame: 3 months
Analogue Scale (VAS) 0 to 100, where 0 is no pain and 100 intolerable pains
1 secondary outcome
quality of life
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2016.
- Results publication: PubMed 26770781Berg 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stig A Slørdahl, md prof study director
St. Olavs Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing heat-pack with massage and heat-pack only in people with Heart Diseases and Pain, run by St. Olavs Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01803529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jan 2016.