Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
1 other identifier
interventional
40
1 country
1
Brief Summary
In this study the investigators want to measure the impact or effects of adding cryostimulation to the conservative care of chronic lateral epicondylitis. The rapid fall in skin temperature above the injured tissues is presume to have a positive effect in the healing process. The combination of conservative care and cryostimulation could then be appreciated. The investigators chose to measure these effects with 3 elements: visual analog pain scale, validated elbow questionnaire and pain free grip strength. This pilot study consist in a two arm design, each arm including 15 patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2014
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2014
CompletedFirst Submitted
Initial submission to the registry
November 26, 2014
CompletedFirst Posted
Study publicly available on registry
December 4, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2016
CompletedMay 11, 2016
May 1, 2016
1 year
November 26, 2014
May 10, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Visual Analog Pain Scale
Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10
at inclusion - ninth visit - 3 months after last treatment
Secondary Outcomes (1)
pain free grip strength
at inclusion - ninth visit - 3 months after last treatment
Other Outcomes (1)
Patient Rated Tennis Elbow
at inclusion - ninth visit - 3 months after last treatment
Study Arms (2)
conservative care
ACTIVE COMPARATORthis group of patients will receive the conservative care: myofascial point release and radial head mobilisation
cryostimulation
EXPERIMENTALthis group of patients will receive the conservative care :myofascial point release and radial haed mobilisation and the cryostimulation (30-40 second of cold air application (-70 celsius degree) in order to lower skin temperature around the lateral epicondyle at 4 celsius degree.
Interventions
pressurized cold air (-70 celsius degree) is blown on the skin surface surrounding the lateral epicondyle, creating a rapid decrease in ski temperature. In a 30-40 sec exposition, skin temperature can drop to 4 celsius degree. this rapid decrease is presumed to have a positive healing effect.
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
Eligibility Criteria
You may qualify if:
- Must have pain at lateral elbow (lateral epicondylitis) for at least six months
- Pain must not come from trauma
- Painful palpation of the lateral epicondyle
- At least one out of two positive test: Cozen's, Mill's
You may not qualify if:
- Fibromyalgia
- Diabetes
- Cervical radiculopathy
- Painful shoulder
- Cold intolerance / allergies
- Smoking
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Clinique universitaire de chiropratique
Trois-Rivières, Quebec, G9A 5H7, Canada
Related Publications (5)
Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106.
PMID: 21629462BACKGROUNDRompe JD, Overend TJ, MacDermid JC. Validation of the Patient-rated Tennis Elbow Evaluation Questionnaire. J Hand Ther. 2007 Jan-Mar;20(1):3-10; quiz 11. doi: 10.1197/j.jht.2006.10.003.
PMID: 17254903BACKGROUNDMourot L, Cluzeau C, Regnard J. Hyperbaric gaseous cryotherapy: effects on skin temperature and systemic vasoconstriction. Arch Phys Med Rehabil. 2007 Oct;88(10):1339-43. doi: 10.1016/j.apmr.2007.06.771.
PMID: 17908579BACKGROUNDDingemanse R, Randsdorp M, Koes BW, Huisstede BM. Evidence for the effectiveness of electrophysical modalities for treatment of medial and lateral epicondylitis: a systematic review. Br J Sports Med. 2014 Jun;48(12):957-65. doi: 10.1136/bjsports-2012-091513. Epub 2013 Jan 18.
PMID: 23335238BACKGROUNDCoombes BK, Bisset L, Vicenzino B. Thermal hyperalgesia distinguishes those with severe pain and disability in unilateral lateral epicondylalgia. Clin J Pain. 2012 Sep;28(7):595-601. doi: 10.1097/AJP.0b013e31823dd333.
PMID: 22699135BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nadia Richer Richer, M.Sc.
Clinique universitaire de chiropratique
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- CARE PROVIDER
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Nadia Richer, M.Sc., DC, clinician professor
Study Record Dates
First Submitted
November 26, 2014
First Posted
December 4, 2014
Study Start
September 1, 2014
Primary Completion
September 1, 2015
Study Completion
December 1, 2016
Last Updated
May 11, 2016
Record last verified: 2016-05