Use of TPD Heat Lamp for Tennis Elbow Pain - a Randomized-controlled Trial

NCT00725023 | Terminated Phase 2

• 1 other identifier: CAM01
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Lateral Epicondylitis

Keywords

Pain, chronic pain, tennis elbow, lateral epicondylitis

Outcome Measures

Primary Outcomes (1)

• To determine if TDP© heat lamp is an effective therapy for the alleviation of chronic pain due to lateral epicondylitis (tennis-elbow pain.)

  At completion of trial

Study Arms (2)

1

EXPERIMENTAL

Treatment: TDP© Lamp used Duration of each treatment 30min Course of treatment 3 times a week for 3-4 weeks

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

Device: Dummy TDP© Lamp

Interventions

TDP© Lamp DEVICE

TDP© heat lamp is an electrical device with a heating element sitting behind a ceramic plate made of clay and minerals

1

Dummy TDP© Lamp DEVICE

The dummy TDP© heat lamp is an electrical device with the heating element removed.

2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen's University: lead

Study Sites (1)

Queen's University-CPC, 220 Bagot Street

Kingston, Ontario, K7L 5E9, Canada

Location

MeSH Terms

Conditions

Tennis Elbow; Pain; Chronic Pain

Condition Hierarchy (Ancestors)

Elbow Tendinopathy; Tendinopathy; Muscular Diseases; Musculoskeletal Diseases; Elbow Injuries; Arm Injuries; Wounds and Injuries; Tendon Injuries; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lawrence Leung, MD

  Queen's University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistand Director

Study Record Dates

• First Submitted: July 28, 2008
• First Posted: July 30, 2008
• Study Start: August 1, 2008
• Primary Completion: March 1, 2011
• Study Completion: March 1, 2011
• Last Updated: September 14, 2011

Record last verified: 2011-09

Locations

CA (1)