Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Primary Purpose
Lateral Epicondylitis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
cryostimulation
conservative care
Sponsored by
About this trial
This is an interventional treatment trial for Lateral Epicondylitis focused on measuring cryostimulation
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Fibromyalgia
- Diabetes
- Patient taking more than three medications at the time of inclusion
- Cervical radiculopathy
- Painful shoulder
- Cold intolerance / allergies
- Smoking
- Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion
Sites / Locations
- Clinique universitaire de chiropratique
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
conservative care
cryostimulation
Arm Description
this group of patients will receive the conservative care: myofascial point release and radial head mobilisation
this 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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
pain free grip strength
we will use a hand-held dynamometer to mesure the painfree grip strength of the subjets. Subjects will be asked to gradually increase the grip stregth while the elbow is extented and arm along side of the body. They will be asked to stop when pain is felt. We will take three mesures with each elbow, left and right.
Full Information
NCT ID
NCT02308514
First Posted
November 26, 2014
Last Updated
May 10, 2016
Sponsor
Université du Québec à Trois-Rivières
1. Study Identification
Unique Protocol Identification Number
NCT02308514
Brief Title
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Official Title
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
September 2014 (undefined)
Primary Completion Date
September 2015 (Actual)
Study Completion Date
December 2016 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Université du Québec à Trois-Rivières
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Lateral epicondylitis is one of the most prevalent upper limb conditions that can affect up to 1-3% of the active population. Invalidity and health care costs incurred by this condition are posing a real challenge to our societies knowing that the natural history of the lateral epicondylitis can last from 1 to 2 years. Many therapies have been tested and so far none has proven conclusive when used alone so far (Blanchette and Normand 2011). The use of cryostimulation is widespread in the sport scene without strong literature supporting its evidence. The aim of this study is to quantify the effects of cryostimulation when added to conservative care in the treatment of chronic lateral epicondylitis.
Thirty (30) patients will be divided randomly in two groups:
The control group (n=15) will receive conservative care including myofascial trigger points (involved forearm) and radial head mobilisations (Bergmann & Peterson, 2010).
The experimental group (n=15) will receive the cryostimulation and the conservative treatment as mentioned above.
A total of eight treatments will be given to each patient; the whole protocol lasting four to six weeks. The treatments will be delivered by experienced and trained clinicians in cryostimulation and myofascial treatment protocols.
The effects of the two treatment protocols will be monitored by a validated elbow questionnaire (PRTEE, (Rompe, Overend et al. 2007)), a visual analog pain scale and the pain free grip strength at three moments: at inclusion, at the ninth visit and 3 months after the last treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lateral Epicondylitis
Keywords
cryostimulation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
conservative care
Arm Type
Active Comparator
Arm Description
this group of patients will receive the conservative care: myofascial point release and radial head mobilisation
Arm Title
cryostimulation
Arm Type
Experimental
Arm Description
this 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.
Intervention Type
Device
Intervention Name(s)
cryostimulation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
conservative care
Other Intervention Name(s)
myofascial release
Intervention Description
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
Primary Outcome Measure Information:
Title
Visual Analog Pain Scale
Description
Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10
Time Frame
at inclusion - ninth visit - 3 months after last treatment
Secondary Outcome Measure Information:
Title
pain free grip strength
Description
we will use a hand-held dynamometer to mesure the painfree grip strength of the subjets. Subjects will be asked to gradually increase the grip stregth while the elbow is extented and arm along side of the body. They will be asked to stop when pain is felt. We will take three mesures with each elbow, left and right.
Time Frame
at inclusion - ninth visit - 3 months after last treatment
Other Pre-specified Outcome Measures:
Title
Patient Rated Tennis Elbow
Description
The questionnaire will be filled in by patients at the beginning of the three evaluations: inclusion, ninth visit and 3 months after last treatment
Time Frame
at inclusion - ninth visit - 3 months after last treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Fibromyalgia
Diabetes
Patient taking more than three medications at the time of inclusion
Cervical radiculopathy
Painful shoulder
Cold intolerance / allergies
Smoking
Cortisone infiltration at the painful lateral epicondyle in the month previous to the inclusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadia Richer Richer, M.Sc.
Organizational Affiliation
Clinique universitaire de chiropratique
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinique universitaire de chiropratique
City
Trois-Rivières
State/Province
Quebec
ZIP/Postal Code
G9A 5H7
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
21629462
Citation
Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106.
Results Reference
background
PubMed Identifier
17254903
Citation
Rompe 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.
Results Reference
background
PubMed Identifier
17908579
Citation
Mourot 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.
Results Reference
background
PubMed Identifier
23335238
Citation
Dingemanse 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.
Results Reference
background
PubMed Identifier
22699135
Citation
Coombes 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.
Results Reference
background
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Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
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