A Phase 2/3 interventional study of TDP© Lamp and Dummy TDP© Lamp in Lateral Epicondylitis, sponsored by Queen's University. Terminated at 1 site in Canada. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2011-09-14.
Sponsored by Queen's University · Phase 2/3, Interventional, and Treatment
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.
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.
284 studies on the registry are indexed under Tennis Elbow; 60 are open to participants now.
This study's planned enrollment of 116 is above the median of 50 across 253 interventional studies indexed under Tennis Elbow.
Browse Tennis Elbow studies →Queen's University is the lead sponsor of 199 studies on the registry; 16 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Treatment: TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks
Device: TDP© Lamp
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
TDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals
The dummy TDP© heat lamp is an electrical device with the heating element removed.
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
This study is terminated, as verified in Sep 2011. You cannot join it, but the record below documents what was studied.
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