Lateral EpicondylitisPhase 2/3NCT00725023
Use of TPD Heat Lamp for Tennis Elbow Pain - a Randomized-controlled Trial
A Phase 2/3 study testing TDP© Lamp and Dummy TDP© Lamp in people with Lateral Epicondylitis, run by Queen's University at 1 site in Canada.
Trial summary
Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives rise to pain, and can lead to loss of function and time off work. The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or physiotherapy, local massage or even surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- TDP© Lamp and Dummy TDP© Lamp
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 116 participants
- Where
- 1 siteCanada
- Study dates
- Aug 2008to Mar 2011
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients that have consented.
- Patients diagnosed with tennis elbow pain. Definition of tennis elbow (lateral epicondylitis) is "pain or tenderness on loading relevant muscle on the lateral epicondyle, with no shoulder or wrist pain.". Patients recruited will be interviewed and examined to confirm the clinical diagnosis. The level of pain will be assessed with the visual analogue scale (VAS) and level of functional disability with the QUICKDASH Questionnaire.
- Patients must be between the ages of 18-65.
Who cannot join
- Patients with existing diagnosis of neuropathic pain, metabolic or metastatic bone pain will be excluded. So will patients with recent or previous bone fracture of the elbow and epicondyles.
- Patients taking any form of oral analgesia in the last 2 weeks prior to randomization.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Queen's University-CPC, 220 Bagot Street
Kingston, Ontario, K7L 5E9
About this study
Official title: A Randomized Double-blind Study to Assess the Use of TDP© Heat-lamp as an Effective Therapy for Tennis Elbow Pain (Lateral Epicondylitis Pain)
Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives rise to pain, and can lead to loss of function and time off work.
The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or physiotherapy, local massage or even surgery. In mainland China, tennis elbow pain has also been treated using TDP © Heat-lamp therapy, and is considered to be an effective treatment for this condition.
This study is a clinical trial that seeks to measure the effectiveness of the TDP © Heat-lamp therapy to relieve tennis elbow pain without the use of oral pain medication.
Read the detailed description
Double-blind randomized controlled trial
Patient recruitment
Patients registered in the Electronic Medical Record (EMR) system of the Family Medicine Centre of Queen's University with a confirmed diagnosis of tennis elbow (lateral epicondylitis) in the 12-month period from 1st March 2008 to 31st March 2009, are recruited and studied. An internal email plus paper memo will be circulated to all other Family Physicians in the Centre, requesting their participation in the study. Patients are then selected randomly from the pool.
Entry/Randomization Procedure
All eligible patients enrolled in the study centre will be entered into a patient registration log. This will automatically provide a serial number for that patient that should be used for all documentation and correspondence about this patient. All randomizations will be done centrally by the administrator at the CSPC.
Randomization
A total of 116 patients will be randomized into two equal arms of 58 patients in each. Arm 1 is the trial arm and Arm 2 is the control arm.
Treatment
Arm 1: Patients will be given a four-week course of TDP© Heat-lamp. The heat-lamp will be targeted to the pain site on the elbow. Each treatment will take about 30 minutes.
Arm 2: Patients will be given a four-week course of TDP© Heat-lamp using a dummy TDP© Heat-lamp. A dummy heat-lamp is a modified version of the TDP© Heat-lamp without the intended therapeutic effects. The dummy heat-lamp will be targeted to the pain site on the elbow. Each treatment will take about 30 minutes.
Allocation of Treatment
Treatment is executed by staff nurses at the Centre. The staff nurse will be blinded to the coding of the TDP© Heat-lamps, and will operate the lamp for 30 minutes at a specified distance of 20cm from the surface of the affected limb of each patient.
During the course of treatment, patients will be advised not to use any other means of analgesia. If they do, it must be recorded in a patient diary provided to them for use during the study. Patients that have taken oral medication may be considered to be inadmissible subjects during the final analysis.
Dose Adjustment
There is no dose adjustment permitted. During the treatment, patients will be regularly monitored for the development of any undue discomfort. If discomfort is experienced by a patient, treatment will be terminated immediately.
- Conditions
- Lateral Epicondylitis
- Being tested
- TDP© Lamp, Dummy TDP© Lamp
- Keywords
- Pain, chronic pain, tennis elbow, lateral epicondylitis
- Medical subject headings
- Tennis Elbow, Pain, Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TDP© LampDevice
TDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals
Dummy TDP© LampDevice
The dummy TDP© heat lamp is an electrical device with the heating element removed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Treatment: TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks Receives: Device: TDP© Lamp |
| 2 | Other | Treatment: Dummy TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks Receives: Device: Dummy TDP© Lamp |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.)
Measured: At completion of trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionMar 2011
- Study completionMar 2011
Why it stopped: Slow accrual
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen's University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jyoti Kotecha, Queen's University
- Investigators
- Lawrence Leung, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725023
- Sponsor's protocol ID
- CAM01
- Status last verified
- Sep 2011
- First submitted
- 28 Jul 2008
- Last updated
- 14 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Study to Assess the Use of TDP© Heat-lamp as an Effective Therapy for Tennis Elbow Pain (Lateral Epicondylitis Pain)
- ClinicalTrials.gov ID
- NCT00725023
- Acronym / sponsor ID
- CAM01
- Conditions
- Lateral Epicondylitis
- Keywords
- Pain, chronic pain, tennis elbow, lateral epicondylitis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow accrual
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- Queen's UniversityUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 30 Jul 2008 (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.
Tennis elbow (Lateral epicondylitis) is a common condition seen in Family Medicine that gives rise to pain, and can lead to loss of function and time off work.
The normal treatment for tennis elbow pain is oral pain relief medication (analgesia), and/or physiotherapy, local massage or even surgery. In mainland China, tennis elbow pain has also been treated using TDP © Heat-lamp therapy, and is considered to be an effective treatment for this condition.
This study is a clinical trial that seeks to measure the effectiveness of the TDP © Heat-lamp therapy to relieve tennis elbow pain without the use of oral pain medication.
Detailed description
Double-blind randomized controlled trial
Patient recruitment
Patients registered in the Electronic Medical Record (EMR) system of the Family Medicine Centre of Queen's University with a confirmed diagnosis of tennis elbow (lateral epicondylitis) in the 12-month period from 1st March 2008 to 31st March 2009, are recruited and studied. An internal email plus paper memo will be circulated to all other Family Physicians in the Centre, requesting their participation in the study. Patients are then selected randomly from the pool.
Entry/Randomization Procedure
All eligible patients enrolled in the study centre will be entered into a patient registration log. This will automatically provide a serial number for that patient that should be used for all documentation and correspondence about this patient. All randomizations will be done centrally by the administrator at the CSPC.
Randomization
A total of 116 patients will be randomized into two equal arms of 58 patients in each. Arm 1 is the trial arm and Arm 2 is the control arm.
Treatment
Arm 1: Patients will be given a four-week course of TDP© Heat-lamp. The heat-lamp will be targeted to the pain site on the elbow. Each treatment will take about 30 minutes.
Arm 2: Patients will be given a four-week course of TDP© Heat-lamp using a dummy TDP© Heat-lamp. A dummy heat-lamp is a modified version of the TDP© Heat-lamp without the intended therapeutic effects. The dummy heat-lamp will be targeted to the pain site on the elbow. Each treatment will take about 30 minutes.
Allocation of Treatment
Treatment is executed by staff nurses at the Centre. The staff nurse will be blinded to the coding of the TDP© Heat-lamps, and will operate the lamp for 30 minutes at a specified distance of 20cm from the surface of the affected limb of each patient.
During the course of treatment, patients will be advised not to use any other means of analgesia. If they do, it must be recorded in a patient diary provided to them for use during the study. Patients that have taken oral medication may be considered to be inadmissible subjects during the final analysis.
Dose Adjustment
There is no dose adjustment permitted. During the treatment, patients will be regularly monitored for the development of any undue discomfort. If discomfort is experienced by a patient, treatment will be terminated immediately.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: TDP© LampTreatment: TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks |
| 2 | Other | Device: Dummy TDP© LampTreatment: Dummy TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients that have consented.
- Patients diagnosed with tennis elbow pain. Definition of tennis elbow (lateral epicondylitis) is "pain or tenderness on loading relevant muscle on the lateral epicondyle, with no shoulder or wrist pain.". Patients recruited will be interviewed and examined to confirm the clinical diagnosis. The level of pain will be assessed with the visual analogue scale (VAS) and level of functional disability with the QUICKDASH Questionnaire.
- Patients must be between the ages of 18-65.
Key exclusion criteria (2 listed)
- Patients with existing diagnosis of neuropathic pain, metabolic or metastatic bone pain will be excluded. So will patients with recent or previous bone fracture of the elbow and epicondyles.
- Patients taking any form of oral analgesia in the last 2 weeks prior to randomization.
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 |
|---|---|---|
| TDP© LampTDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals | Device | 1 |
| Dummy TDP© LampThe dummy TDP© heat lamp is an electrical device with the heating element removed. | Device | 2 |
Primary outcome
To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.)
Time frame: At completion of trial
Results and safety
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2011.
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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.
Lawrence Leung, MD principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing TDP© Lamp and Dummy TDP© Lamp in people with Lateral Epicondylitis, run by Queen's University at 1 site in Canada.
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 2 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: stopped early, as of the sponsor's last update on 14 Sep 2011. 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 Canada. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow accrual). Results are not available in the source record.
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?
To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.) (time frame: At completion of trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Sep 2011.