|
ISRCTN
|
ISRCTN65048343
|
|
ClinicalTrials.gov identifier
|
|
|
Public title
|
Conservative Treatment for Tennis Elbow
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
N0284183280
|
|
Study hypothesis
|
1.To investigate whether muscle function (EMG) and thermal changes show a relationship with pain/inflammation
2. To investigate the immediate effects on muscle function using EMG and on inflammation using thermographic analysis in the different treatment groups.
3. To investigate the sustainability of EMG and thermographic changes in the different treatment groups.
4. To determine whether EMG and thermography can be altered solely by the alieviation of pain/inflammation through injection and ultrasound alone or physiotherapy rehabilitation.
5. To evaluate whether therapy resistant patients I.e. patients who do not respond to treatment can be differentiated from non resistant cases through EMG studies and thermographic analysis.
6. To develop prognostic indications for patients with tennis elbow.
|
|
Lay summary
|
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Prospective randomised, assessor-blinded trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Musculoskeletal Diseases: Tennis elbow
|
|
Participants - inclusion criteria
|
1. Patients referred to physiotherapy with tennis elbow.
2. Diabetics but diagnosis will be noted, any person satisfying the diagnostic criteria who has not had active treatment for the condition within one month and who has had symptoms for less than 18 months at first assessment with established symptoms and suitable for either treatment
3. Age 35 to 65 years.
|
|
Participants - exclusion criteria
|
Abnormal x-rays including calcific tendonitis, glenohumeral OA, 50% loss of passive glenohumeral joint movement, normal x-rays (non symptomatic radiological AC joint arthritis accepted)
|
|
Anticipated start date
|
01/07/2006
|
|
Anticipated end date
|
01/10/2009
|
|
Status of trial
|
Completed |
|
Patient information material
|
|
|
Target number of participants
|
30 patients in each group
|
|
Interventions
|
All patients referred with tennis elbow to the Trust will be assessed by the chief investigator in a standardised manner according to defined eligibility criteria. The only intervention is a 10 minute questionnaire.
Group 1 = Exercise class
Group 2 = Individual physio
Group 3 = Supervised classes (at home)
|
|
Primary outcome measure(s)
|
The primary outcome measure is constant score for the three groups will be compared at three months to assess whether there is any difference in the recovery at this point.
|
|
Secondary outcome measure(s)
|
The VAS and OSS scores will be analysed at three months for differences between the three groups. All three scores will be analysed at six months and two years to see if there is any differences in the groups in the longer term.
|
|
Sources of funding
|
Wrightington, Wigan and Leigh NHS Trust
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Ms
Jeanette
Tonks
|
|
Address
|
Physio Department
Royal Albert Edward Infirmary
Wigan Lane
|
|
City/town
|
Wigan
|
|
Zip/Postcode
|
WN1 2NN
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 01942 822103
|
|
Fax
|
+44
|
|
Email
|
Jeanette.Williams@wiganlhs-tr.nwest.nhs.uk
|
|
Sponsor
|
Record Provided by the NHSTCT Register - 2007 Update - Department of Health
|
|
Address
|
The Department of Health, Richmond House, 79 Whitehall
|
|
City/town
|
London
|
|
Zip/Postcode
|
SW1A 2NL
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)20 7307 2622
|
|
Fax
|
+44
|
|
Email
|
dhmail@doh.gsi.org.uk
|
|
Sponsor website:
|
http://www.dh.gov.uk/Home/fs/en
|
|
Date applied
|
28/09/2007
|
|
Last edited
|
05/11/2007
|
|
Date ISRCTN assigned
|
28/09/2007
|
