| Source of record | UK Trials |
| ISRCTN | ISRCTN89551492 |
| Date ISRCTN assigned | 28/09/2007 |
| Local reference number(s) | N0046187175 |
| Public title | An investigation of the effectiveness of a Mobilisation with Movement (MWM) technique for Lateral Epicondylagia on pain and function in clinical practice |
| Scientific title |
|
| Acronym | N/A |
| Disease/condition/study domain | Musculoskeletal Diseases: Tennis elbow |
| Study hypothesis | Does the use of a Mobilisation with Movement technique improve pain and function in patients with chronic Lateral Epicondylagia (Tennis Elbow) when used in a clinical setting? |
| Design/methodology | Randomised controlled trial |
| Research ethics review | Not provided at time of registration |
| Countries of trial | United Kingdom |
| Participants - inclusion criteria | 1. Patients diagnosed with chronic lateral epicondylagia (this is a clinical diagnosis based on previously established criteria, i.e. pain over the lateral side of the elbow provoked by palpitation of the lateral epicondyle region and gripping tasks, pain over the lateral epicondyle during either resisted static contraction or stretching of the forearm extensor muscles, and symptoms of greater than 6 weeks duration)
2. Both male and female patients
3. Adults ie patients over 18 years old |
| Participants - exclusion criteria | Not provided at time of registration |
| Patient information material |
|
| Anticipated start date | 01/03/2006 |
| Anticipated end date | 01/05/2007 |
| Status of trial | Completed |
| Target number of participants | Not provided at time of registration |
| Interventions | Participants will be selected from a population of all patients referred to the Physiotherapy Department at Solihull Hospital with a diagnosis of Lateral Epicondylagia, Lateral Epincondylitis, Tennis Elbow or lateral elbow pain.
In order to assess the effectiveness of the technique, a randomised controlled trial is proposed. This will involve randomly putting patients into two groups, ie, a treatment group and a control group.
All patients will receive a thorough assessment of their elbow problem and asked to answer questions which will both evaluate their suitability for inclusion or need for exclusion from the trial and provide descriptive information allowing for comparison of the characteristics of the two groups. Baseline values for pain-free grip strength and the Patient-Rated Forearm Evaluation Questionnaire (PRFEQ) will be collected. Both pain-free grip strength and the PRFEQ are assessment tools which have been shown to be valid and reliable in assessing pain and function in patients with Lateral Epicondylagia (Tennis Elbow). Pain-free grip strength will be measured using a hand grip dynamometer with a digital display. The value on the display will be read by a Physiotherapy Assistant in order to prevent bias by the researcher. Patients will be asked to fill out the questionnaire (PRFEQ) themselves. This is a 15 item questionnaire which takes about 5 minutes to complete. In order to prevent bias by the researcher, the randomisation process will be carried out by reception staff at Solihull Hospital, who will select a sealed envelope from a box. In the envelopes there will be equal numbers of cards stating 'group 1' and 'group 2'. The randomisation process should maximise the likelihood of the two groups being equal, eg age, gender, hand dominance, duration of symptoms.
Group 1 will be the treatment group. They will asked to attend the physiotherapy department twice a week for three weeks.
Group 2 will be the control group. They will simply be given an appointment to attend for reassessment 3 weeks later.
At the final attendance within the study, both groups will have pain-free strength re-measured and be asked to repeat the questionnaire (PRFEQ).
Following their involvement in the trial, regardless of the group they are assigned to, all patients for whom further treatment is necessary will be offered further appointments. |
| Primary outcome measure(s) | Outcome measures for the study are Pain-free grip strength and the Patient-Related Forearm Evaluation Questionnaire (PRFEQ). Each of these outcome measures has been shown to be a valid and reliable method of both pain and function. |
| Secondary outcome measure(s) | Not provided at time of registration |
| Sources of funding | Heart of England NHS Foundation Trust |
| Sponsor name | Record Provided by the NHSTCT Register - 2007 Update - Department of Health |
| Sponsor details | The Department of Health, Richmond House, 79 Whitehall
London
United Kingdom
SW1A 2NL |
| Sponsor telephone | +44 (0)20 7307 2622 |
| Sponsor fax | +44 |
| Sponsor email | dhmail@doh.gsi.org.uk |
| Sponsor website | http://www.dh.gov.uk/Home/fs/en |
| Contact name | Ms Alison Bartlett |
| Contact details | Physiotherapy Department
Solihull Hospital
Solihull
United Kingdom
B91 2JL |
| Contact telephone | +44 0121 424 5446 |
| Contact fax | +44 |
| Contact email | alison.bartlett@heartofengland.nhs.uk |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN89551492 |
| Date last extracted from ISRCTN register | 17/04/2008 |
