An investigation of the effectiveness of a Mobilisation with Movement (MWM) technique for lateral epicondylagia on pain and function in clinical practice

ISRCTN	ISRCTN89551492
DOI	https://doi.org/10.1186/ISRCTN89551492
Secondary identifying numbers	N0046187175

Submission date: 28/09/2007
Registration date: 28/09/2007
Last edited: 18/05/2017

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 Alison Bartlett
Scientific

Physiotherapy Department
Solihull Hospital
Solihull
B91 2JL
United Kingdom

Phone	+44 (0) 121 424 5446
Email	alison.bartlett@heartofengland.nhs.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	An investigation of the effectiveness of a Mobilisation with Movement (MWM) technique for lateral epicondylagia on pain and function in clinical practice
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?
Ethics approval(s)	Not provided at time of registration
Condition	Musculoskeletal diseases: tennis elbow
Intervention	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, i.e. 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, e.g. 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.
Intervention type	Other
Primary outcome measure	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 measures	Not provided at time of registration
Overall study start date	01/03/2006
Overall study end date	01/05/2007

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Both
Target number of participants	Not provided at time of registration
Participant 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, i.e. patients over 18 years old
Participant exclusion criteria	Not provided at time of registration
Recruitment start date	01/03/2006
Recruitment end date	01/05/2007

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

Physiotherapy Department

Solihull
B91 2JL
United Kingdom

Sponsor information

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

Heart of England NHS Foundation Trust (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

18/05/2017: No publications found in PubMed, verifying study status with principal investigator.