Conservative Treatment for Tennis Elbow

ISRCTN	ISRCTN65048343
DOI	https://doi.org/10.1186/ISRCTN65048343
Protocol serial number	N0284183280
Sponsor	Record Provided by the NHSTCT Register - 2007 Update - Department of Health
Funder	Wrightington, Wigan and Leigh NHS Trust

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 24/08/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms Jeanette Tonks
Scientific

Physio Department
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom

Phone	+44 01942 822103

Study information

Primary study design	Interventional
Study design	Prospective randomised, assessor-blinded trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	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.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Musculoskeletal Diseases: Tennis elbow
Intervention	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)
Intervention type	Other
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.
Key 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.
Completion date	01/10/2009

Eligibility

Participant type(s)	Patient
Age group	Not Specified
Sex	Not Specified
Target sample size at registration	90
Key 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.
Key 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)
Date of first enrolment	01/07/2006
Date of final enrolment	01/10/2009

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Physio Department

Wigan
WN1 2NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan