Condition category
Musculoskeletal Diseases
Date applied
28/09/2007
Date assigned
28/09/2007
Last edited
24/08/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms Jeanette Tonks

ORCID ID

Contact details

Physio Department
Royal Albert Edward Infirmary
Wigan Lane
Wigan
WN1 2NN
United Kingdom
+44 01942 822103

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0284183280

Study information

Scientific title

Acronym

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.

Ethics approval

Not provided at time of registration

Study design

Prospective randomised, assessor-blinded trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 measures

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.

Overall trial start date

01/07/2006

Overall trial end date

01/10/2009

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

30 patients in each group

Participant 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)

Recruitment start date

01/07/2006

Recruitment end date

01/10/2009

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Physio Department
Wigan
WN1 2NN
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2007 Update - Department of Health

Sponsor details

The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk

Sponsor type

Government

Website

http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Funder name

Wrightington, Wigan and Leigh NHS Trust

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes