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| Sponsored by: |
Queen's University |
|---|---|
| Information provided by: | Queen's University |
| ClinicalTrials.gov Identifier: | NCT00725023 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Lateral Epicondylitis |
Device: TDP© Lamp Device: Dummy TDP© Lamp |
Phase II Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver), Placebo Control, Single Group Assignment, Efficacy 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) |
| Estimated Enrollment: | 116 |
| Study Start Date: | August 2008 |
| Estimated Study Completion Date: | October 2009 |
| Estimated Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Treatment: TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks
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Device: TDP© Lamp
TDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals
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|
2
Treatment: Dummy TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks
|
Device: Dummy TDP© Lamp
The dummy TDP© heat lamp is an electrical device with the heating element removed.
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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.
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Canada, Ontario | |
| Queen's University-CPC, 220 Bagot Street | |
| Kingston, Ontario, Canada, K7L 5E9 | |
| Principal Investigator: | Lawrence Leung, MD | Queen's University |
More Information
| Responsible Party: | Queen's University ( Dr Lawrence Leung ) |
| Study ID Numbers: | CAM01 |
| Study First Received: | July 28, 2008 |
| Last Updated: | January 19, 2009 |
| ClinicalTrials.gov Identifier: | NCT00725023 History of Changes |
| Health Authority: | Canada: Ethics Review Committee |
|
Pain, chronic pain, tennis elbow, lateral epicondylitis |
|
Musculoskeletal Diseases Tennis Elbow Wounds and Injuries |
Disorders of Environmental Origin Pain Arm Injuries |
|
Musculoskeletal Diseases Tennis Elbow Wounds and Injuries Disorders of Environmental Origin Arm Injuries |
