Lateral EpicondylitisNCT02308514
Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
A study testing cryostimulation and conservative care in people with Lateral Epicondylitis, run by Université du Québec à Trois-Rivières at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- cryostimulation and conservative care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Clinique universitaire de chiropratique
Trois-Rivières, Quebec, G9A 5H7
About this study
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.
Read the 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.
- Conditions
- Lateral Epicondylitis
- Being tested
- cryostimulation, conservative care
- Keywords
- cryostimulation
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cryostimulationDevice
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.
conservative careOther
Also called myofascial release
manual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head.
| Study group | Role | What they receive |
|---|---|---|
| conservative care | Active comparator | this group of patients will receive the conservative care: myofascial point release and radial head mobilisation Receives: Other: conservative care |
| cryostimulation | Experimental | 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. Receives: Device: cryostimulation; Other: conservative care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at inclusion - ninth visit - 3 months after last treatment
Secondary outcomes (1)
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.
Measured: at inclusion - ninth visit - 3 months after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2014 (estimated)
- Study startSep 2014
- Primary completionSep 2015
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Université du Québec à Trois-Rivières
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Richer, Université du Québec à Trois-Rivières
- Investigators
- Nadia Richer Richer, M.Sc., Principal investigator, Clinique universitaire de chiropratique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02308514
- Sponsor's protocol ID
- CER-14-203-07.08
- Status last verified
- May 2016
- First submitted
- 26 Nov 2014
- Last updated
- 11 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106.
PubMed 21629462Rompe 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.
PubMed 17254903Mourot 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.
PubMed 17908579Dingemanse 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.
PubMed 23335238Coombes 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.
PubMed 22699135
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Adding Cryostimulation to Conservative Care Help in Managing Chronic Lateral Epicondylitis? a Pilote Study
- ClinicalTrials.gov ID
- NCT02308514
- Acronym / sponsor ID
- CER-14-203-07.08
- Conditions
- Lateral Epicondylitis
- Keywords
- cryostimulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Université du Québec à Trois-RivièresUniversity, hospital or other
- Study start
- Sep 2014
- Primary completion
- Sep 2015 (actual)
- Study completion
- Dec 2016 (estimated)
- First posted
- 4 Dec 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conservative care | Active comparator | Other: conservative carethis group of patients will receive the conservative care: myofascial point release and radial head mobilisation |
| cryostimulation | Experimental | Device: cryostimulation, Other: conservative carethis 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- Fibromyalgia
- Diabetes
- Patient taking more than three medications at the time of inclusion
- Cervical radiculopathy
- Painful shoulder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cryostimulationpressurized 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. | Device | cryostimulation |
| conservative careAlso: myofascial releasemanual treatment of localized tender and painful myofascial areas in the muscles surrounding the forearm and mobilization of the radial head. | Other | conservative care, cryostimulation |
Primary outcome
Visual Analog Pain Scale
Time frame: at inclusion - ninth visit - 3 months after last treatment
Subjects will be asked to rate their average pain for the last 24 hours on a scale ranging from 0 to 10
1 secondary outcome
pain free grip strength
Time frame: at inclusion - ninth visit - 3 months after last treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2016.
- Background: PubMed 21629462Blanchette MA, Normand MC. Impairment assessment of lateral epicondylitis through electromyography and dynamometry. J Can Chiropr Assoc. 2011 Jun;55(2):96-106.
- Background: PubMed 17254903Rompe 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.
- Background: PubMed 17908579Mourot 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.
- Background: PubMed 23335238Dingemanse 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.
- Background: PubMed 22699135Coombes 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.
Related trials for Lateral Epicondylitis
Recruiting
Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
Lateral Epicondylitis
Not yet recruiting
Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
Lateral Epicondylitis
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Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruitingObservational study
Metabolic and Inflammatory Indices in Lateral Epicondylitis
Lateral Epicondylitis
Not yet recruiting
Effectiveness of Topical Chinese Medicine Ointment Therapy (TCMO) (Ng's Prescription) Eccentric Exercise for Tennis Elbow as Control: a Randomized Controlled Trial.
Lateral Epicondylitis, TCMO (Ng's Prescription)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia Richer Richer, M.Sc. principal investigator
Clinique universitaire de chiropratique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing cryostimulation and conservative care in people with Lateral Epicondylitis, run by Université du Québec à Trois-Rivières at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Pain Scale (time frame: at inclusion - ninth visit - 3 months after last treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02308514, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2016.