ISRCTN ISRCTN65048343
DOI https://doi.org/10.1186/ISRCTN65048343
Secondary identifying numbers N0284183280
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

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

Study designProspective randomised, assessor-blinded trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific title
Study hypothesis1.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
ConditionMusculoskeletal Diseases: Tennis elbow
InterventionAll 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 typeOther
Primary outcome measureThe 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 measuresThe 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 study start date01/07/2006
Overall study end date01/10/2009

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participants30 patients in each group
Participant inclusion criteria1. 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 exclusion criteriaAbnormal 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 date01/07/2006
Recruitment end date01/10/2009

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

Physio Department
Wigan
WN1 2NN
United Kingdom

Sponsor information

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

The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom

Phone +44 (0)20 7307 2622
Email dhmail@doh.gsi.org.uk
Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Government

Wrightington, Wigan and Leigh NHS Trust

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan