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Trial registered on ANZCTR


Registration number
ACTRN12612000993897
Ethics application status
Approved
Date submitted
10/09/2012
Date registered
17/09/2012
Date last updated
11/07/2019
Date data sharing statement initially provided
11/07/2019
Date results information initially provided
11/07/2019
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of Prolotherapy Injections and an Exercise Program Used Singly and In Combination for Refractory Tennis Elbow.
Scientific title
Randomised clinical trial to evaluate the effect of prolotherapy (Prt) injections and physiotherapy consisting of Mulligan's MWM and exercise (P/E) used singly and in combination, on pain and function in patients with lateral epicondylalgia (Tennis Elbow).
Secondary ID [1] 281193 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral epicondylalgia (Tennis Elbow) 287374 0
Condition category
Condition code
Physical Medicine / Rehabilitation 287707 287707 0 0
Other physical medicine / rehabilitation
Musculoskeletal 287760 287760 0 0
Other muscular and skeletal disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Group 1- Physiotherapy and Therapeutic Exercise: a multimodal program comprising education, manual therapy and therapeutic exercise, and a home exercise program. Four, 30 minute physiotherapy sessions will be provided by a qualified physiotherapist over a 4-week period. Specific manual therapy techniques known as Mobilisation with Movement (MWM) will be applied. In addition, three main groups of exercises will be pragmatically prescribed: (a) Sensorimotor retraining of gripping and forearm movements and posture correction will be commenced early in the physiotherapy intervention; (b) progressive resistance exercise for the wrist extensors will be prescribed based on identified strength deficits in LE; (c) exercises geared towards general arm strengthening. Physiotherapists will prescribe exercises based on the participant's capabilities at any given session to allow for optimal exercise volume and load setting without exacerbating pain. The overriding rule for all exercise is that pain should not be provoked during or after exercise, including avoidance of delayed onset muscle soreness. Exercises will be performed in a slow manner with sufficient rest between sets to allow recovery, and correct form and posture emphasised throughout. Supervision of the home program at the commencement of every session and monitoring of exercise diaries by the treating practitioners will be used to facilitate program adherence and emphasise the importance of the exercise and self-treatment program.
Group 2- Prolotherapy injection - the injection solution contains 20% glucose and 0.4% lignocaine. Injection sites will be determined by palpation for tenderness over the lateral epicondyle, the supracondylar ridge, the radial head, the common extensor insertion and the lateral collateral and annular ligaments. Each tender area will receive 0.5 to 1.0 ml using a peppering technique with a 25 gauge needle to a total of 2.0 ml. Injections will be given by a Musculoskeletal Medicine practitioner and will be repeated at 4, 8 and 12 weeks after the initial injections, giving a total of 4 treatments, each lasting approximately 30 minutes.
Group 3- Combination of 1) Physiotherapy and Therapeutic Exercise and 2) Prolotherapy injection.
Intervention code [1] 285659 0
Rehabilitation
Intervention code [2] 285701 0
Treatment: Other
Comparator / control treatment
Group 1 - Physiotherapy and Therapeutic Exercise
Control group
Active

Outcomes
Primary outcome [1] 287959 0
Assessment of Pain and Functional Disability - using the Patient-rated Tennis Elbow Evaluation (PRTEE) questionnaire.
Timepoint [1] 287959 0
1) Baseline
2) Week 4
3) Week 8
4) Week 12
5) Week 26
6) Week 52
Primary outcome [2] 287960 0
Level of Improvement - The participant's global perceived level of improvement will be measured on a 6-point Likert scale ranging from 'completely recovered' to 'much worse'.
Timepoint [2] 287960 0
1) Baseline
2) Week 4
3) Week 8
4) Week 12
5) Week 26
6) Week 52
Secondary outcome [1] 299128 0
Quality of Life/Generic Health Status measures: SF-12 and EQ-5D-5L questionnaires.
Timepoint [1] 299128 0
1) Baseline
2) Week 4
3) Week 8
4) Week 12
5) Week 26
6) Week 52
Secondary outcome [2] 299129 0
Relative stiffness and variation in peak stiffness using grey scale ultrasound. Ultrasound scanning will be done using a linear array transducer (7.5MHz) integrated into a PC-based ultrasound system (Echo Blaster 64, TELEMED, Lithiania) with scan settings optimized for optimum tendon characterisation within the image. Gain settings will be fixed throughout all measurements at 50%.
Timepoint [2] 299129 0
1) Baseline
2) Week 4
3) Week 8
4) Week 12
5) Week 26
6) Week 52
Secondary outcome [3] 299142 0
Costs - The societal perspective will be used, to capture both direct costs related to the management of LE (health professional visits, medications, braces) and indirect costs related to lost productivity. Data on resource use/productivity will be collected monthly via an internet-based questionnaire with a reminder system to maximise response and minimise recall bias.
Timepoint [3] 299142 0
Monthly for a period of 12 months.

Eligibility
Key inclusion criteria
Unilateral lateral elbow pain over the lateral epicondyle of at least 6 weeks duration which is aggravated by gripping, resisted wrist/finger extension and palpation, reduced pain-free grip force, as well as a minimum pain severity of 30 on a 0-100 mm visual analogue scale.
Minimum age
18 Years
Maximum age
60 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Current pregnancy or breast feeding; presence of peripheral nerve involvement or cervical radiculopathy; systemic disorders including diabetes, rheumatoid arthritis or bleeding disorders; concomitant neck or other arm pain preventing usual work or recreation or necessitated treatment within the last 3 months; evidence of other primary sources of lateral elbow pain including osteoarthritis; sensory disturbance in the affected hand; history of upper limb dislocations, fractures or tendon ruptures within the preceding 10 years; allergy to corn, maize, or seafood; history of corticosteroid injection to the affected elbow within the previous 3 months; history of elbow surgery, malignancy or any medical condition which may contraindicate any of the study treatments; or unresolved litigation.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
All participants will be randomised to each arm of the clinical trial; Physiotherapy and therapeutic exercise, prolotherapy injection, or combination groups. Allocation is concealed by central randomisation by phone.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Random order generation using a computer
generated program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1 / Phase 2
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 285978 0
Charities/Societies/Foundations
Name [1] 285978 0
Hacket Hemwall Foundation
Address [1] 285978 0
2532 Balden Street
Madison
Wisconsin 53713
Country [1] 285978 0
United States of America
Funding source category [2] 285979 0
Charities/Societies/Foundations
Name [2] 285979 0
Australian Association of Musculoskeletal Medicine
Address [2] 285979 0
School of Medicine
Logan Campus, Griffith University
University Drive
Meadowbrook QLD 4131
Country [2] 285979 0
Australia
Funding source category [3] 286012 0
Charities/Societies/Foundations
Name [3] 286012 0
Australasian Faculty of Musculoskeletal Medicine (Australian Division)
Address [3] 286012 0
1st Floor
67 Brighton Road
Sandgate
QLD 4017
Country [3] 286012 0
Australia
Primary sponsor type
University
Name
Griffith University
Address
170 Kessels Road
Nathan
QLD 4111
Country
Australia
Secondary sponsor category [1] 284798 0
None
Name [1] 284798 0
Address [1] 284798 0
Country [1] 284798 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 288011 0
Griffith University Human Research Ethics Committee
Ethics committee address [1] 288011 0
170 Kessels Road
Nathan
QLD 4111
Ethics committee country [1] 288011 0
Australia
Date submitted for ethics approval [1] 288011 0
Approval date [1] 288011 0
15/04/2012
Ethics approval number [1] 288011 0
PES/11/12/HREC

Summary
Brief summary
This project aims to find an effective treatment that provides value for money and is acceptable to patients for the management of moderate-to-severe lateral epicondylalgia, a common, disabling and costly condition.
Trial website
Trial related presentations / publications
None
Public notes

Contacts
Principal investigator
Name 34690 0
A/Prof Michael Yelland
Address 34690 0
Griffith University
Gold Coast Campus
Clinical Sciences 1 (G02) 2.11
Parklands Drive, Southport, QLD 4222
Country 34690 0
Australia
Phone 34690 0
+61,7,37357111
Fax 34690 0
Email 34690 0
M.Yelland@griffith.edu.au
Contact person for public queries
Name 17937 0
Dr Dr Michael Ryan
Address 17937 0
Musculoskeletal Research Program
Griffith University
Gold Coast campus
Clinical Sciences 1 (G02) 2.11
Parklands Drive,
Southport,
QLD 4222
Country 17937 0
Australia
Phone 17937 0
+61-7-55527443
Fax 17937 0
+61-7-55528674
Email 17937 0
mryan@kintec.net
Contact person for scientific queries
Name 8865 0
Dr Dr Michael Ryan
Address 8865 0
Musculoskeletal Research Program
Griffith University
Gold Coast campus
Clinical Sciences 1 (G02) 2.11
Parklands Drive,
Southport,
QLD 4222
Country 8865 0
Australia
Phone 8865 0
+617-55527443
Fax 8865 0
+61755528674
Email 8865 0
m_ryan@sfu.ca

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
There are no plans, or requirements, for data sharing outside of study personnel for this project.
What supporting documents are/will be available?
No other documents available
Summary results
Have study results been published in a peer-reviewed journal?
No
Other publications
Have study results been made publicly available in another format?
Yes
Other publication details
Citation type [1] 1992 0
Presentation
Citation/DOI/link/details [1] 1992 0
Clinical outcomes presented at the Hackett-Hemwell Foundation Research Day on October, 2017
Attachments [1] 1992 0
Results – basic reporting
Results – plain English summary
ABSTRACT
Objective: Lateral epicondylalgia (LE, tennis elbow) is a common, debilitating and often treatment-resistant condition. Two treatments thought to address the pathology of LE are hypertonic glucose plus lignocaine injections (prolotherapy) and a physical therapist guided manual therapy/exercise program (PT). This trial aimed to compare the short- and long-term clinical effectiveness, cost effectiveness, and safety of prolotherapy used singly and in combination with PT.
Design: Single-blinded randomized clinical trial.
Methods: 120 participants with LE of at least six weeks’ duration were randomly assigned to prolotherapy (4 sessions, monthly intervals), PT (weekly for 4 sessions) or combined (prolotherapy+PT). Patient-Rated Tennis Elbow Evaluation (PRTEE) and participant global impression of change scores were assessed by blinded evaluators at baseline, 6, 12, 26 and 52 weeks. Success rate was defined as the percentage of participants indicating elbow condition was either 'much improved' or 'completely recovered.’ Analysis was by intention-to-treat.
Results: 88% completed the 12-month assessment. At 52 weeks, there were substantial, significant improvements compared with baseline status for all outcomes and groups, but no significant differences between groups. The PT group exhibited greater reductions in PRTEE at 6 and 12 weeks than the prolotherapy group. Duration of illness of less than 6 months predicted success rate, regardless of treatment.
Conclusions: Pain and function measures improved substantially in all groups, more quickly in the PT group than prolotherapy group. The addition of prolotherapy to PT did not influence the rate of recovery.