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Trial registered on ANZCTR


Registration number
ACTRN12616001599460
Ethics application status
Approved
Date submitted
25/10/2016
Date registered
18/11/2016
Date last updated
27/02/2020
Date data sharing statement initially provided
27/02/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Effectiveness of a combined treatment of dry needling with an exercise program in patients with tennis elbow.
Scientific title
Effectiveness of a combined treatment of dry needling with an isometric exercise program in patients with lateral epicondylalgia.
Secondary ID [1] 290379 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Lateral epicondylalgia 300669 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300518 300518 0 0
Physiotherapy
Musculoskeletal 300649 300649 0 0
Other muscular and skeletal disorders
Injuries and Accidents 300650 300650 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Dry needling combined with an isometric exercise program.
The intervention will be 4-week intervention program with 2 weekly treatment sessions.
-Dry needling will be performed once a week on the 1st weekly session using sterilized surgical steel disposable needles (0.3x40mm; APS (Registered Trademark), AGU-PUNT, S.L., Barcelona, Spain). The technique described by Hong will be used, which consist on fast in and out movements with the needle. The technique will be performed on the muscles of the lateral epicondyle. It will be performed by a physiotherapist with more than 10 years of clinical experience and knowledge on the technique. The duration of this part of the treatment is 10 minutes approximately.
-The isometric exercise program will be done twice a week. It consists of 3 series of 10 hand-grip isometric contractions mantained 10 seconds each, and 10 rest seconds between contractions. The force of the hand-grip will be performed 20% under the forced obtained on the pain free grip strenght test. For the treatment a Riester Minimus (Registered Trademark) II sphygmomanometer will be used. It will be supervised by a physiotherapist. The exercises will take approximately 20 minutes to be performed.
-During the first weekly session dry needling will be performed first, followed by a 5 minutes rest, and then the exercise program will be performed.
For monitoring the adherence of patients to the study an attendance sheet in which they will have to sign each session will be done.
-Intervention will be performed at Universidad de Alcala.
Intervention code [1] 296190 0
Rehabilitation
Intervention code [2] 296311 0
Treatment: Other
Comparator / control treatment
Placebo dry needling combined with an isometric exercise program.
The intervention will be 4-week intervention program with 2 weekly treatment sessions.
-Placebo dry needling will be performed once a week on the 1st weekly session using placebo sterilized surgical steel disposable needles (0,25x40mm; Sham Needles, AcuPrime, Exeter, UK). The technique preparation is the same as for dry needling. The sham needles cause a picking sensation when pushed agains the skin. The needle disappears into the handle with increased pressure. It invoques a similar sensation to the one produced with dry needling.
-The isometric exercise program will be done twice a week. It consists of 3 series of 10 hand-grip isometric contractions mantained 10 seconds each, and 10 rest seconds between contractions. The force of the hand-grip will be performed 20% under the forced obtained on the pain free grip strenght test. For the treatment a Riester Minimus (Registered Trademark) II sphygmomanometer will be used.
-Intervention will be performed at Universidad de Alcala.
Control group
Placebo

Outcomes
Primary outcome [1] 299943 0
Pain measured with a 100mm visual analogue scale
Timepoint [1] 299943 0
Baseline, post treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment.
Secondary outcome [1] 328603 0
Patient Rated Tennis Elbow Evaluation (PRTEE)
Timepoint [1] 328603 0
Baseline post treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment.
Secondary outcome [2] 328604 0
Pain free grip strength test using a dynamometer
Timepoint [2] 328604 0
Baseline, post treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment.
Secondary outcome [3] 328606 0
1st stretch sensation during writst flexion using a goniometer
Timepoint [3] 328606 0
Baseline, post treatment, 1 month post treatment, 3 months post treatment, 6 months post treatment.

Eligibility
Key inclusion criteria
-Lateral epicondylalgia symptoms confirmed with at least 2 of the 4 following test: a) pain during palpation of lateral epicondyle, b) pain on resisted wrist extension, c) pain on resisted middle finger extension, d) pain during hand-grip.
-Lateral epicondylalgia symptoms for more than 3 months
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
-History of fractures, luxations, surgery and/or musculoskeletal disorders in upper limb.
-Neurological disorders, inflammatory and/or degenerative diseases.
-Having received as treatment techniques that involve needles on the previous 6 months to study enrollment, or having received dry needling as a treatment before.
-Cervical pathology, fibromyalgia, unstable cardiovascular diseases, pregnant women or under suspect of pregnancy.
-Contraindications of dry needling: anticoagulant therapy, needle phobia, diabetes, hypothyroidism, lymphoedema, muscular diseases).

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)
Central randomization by computer using Random Allocation Software V1.0.0
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
21/12/2016
Actual
21/12/2016
Date of last participant enrolment
Anticipated
Actual
30/06/2017
Date of last data collection
Anticipated
Actual
15/01/2018
Sample size
Target
38
Accrual to date
Final
38
Recruitment outside Australia
Country [1] 8343 0
Spain
State/province [1] 8343 0
Madrid

Funding & Sponsors
Funding source category [1] 294757 0
University
Name [1] 294757 0
Universidad de Alcala
Country [1] 294757 0
Spain
Primary sponsor type
University
Name
Universidad de Alcala (physiotherapy and pain group)
Address
Edificio de Fisioterapia Campus Universitario
Ctra Madrid-Barcelona Km 33,6000 E-28871
Alcala de Henares , Madrid, E-28871
Country
Spain
Secondary sponsor category [1] 293621 0
None
Name [1] 293621 0
Address [1] 293621 0
Country [1] 293621 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296181 0
Comite etica de la investigacion y de experimentacion animal de la Universidad de Alcala
Ethics committee address [1] 296181 0
Colegio de San Ildefonso, Plaza de San Diego s/n
28801 Alcala de Henares (Madrid)
Ethics committee country [1] 296181 0
Spain
Date submitted for ethics approval [1] 296181 0
21/06/2016
Approval date [1] 296181 0
26/09/2016
Ethics approval number [1] 296181 0
CEIM/HU/2016/13

Summary
Brief summary
The objective of the study is to analyze the effect of dry needling combined with an isometric exercise program in patients with lateral epicondylalgia. The hypothesis proposed for this study is that dry needling combined with an isometric exercise program is more effective than placebo dry needling combined with the same exercise program for treating patients with lateral epicondylalgia regarding pain, functionality and pain free grip strength.
The study design is a randomized clinical trial with blind evaluator. The population of the study are patients with lateral epicondylalgia that met the inclusion and exclusion criteria proposed and accept enrollment in the study.
The study will have two groups, which will receive the same isometric exercise program combined with dry needling (group A) or placebo dry needling (group B). The isometric exercise program has a duration of 4 weeks with 2 weekly sessions, and needling will be performed in the forearm muscles once a week.
The main variable of the study is pain, measured by a 100 mm visual analogue scale (VAS). Secondary variables of the study are Patient Rated Tennis Elbow Evaluation (PRTEE), pain free grip strength, pressure pain threshold, 1st stretch sensation during wrist flexion and surface electromyography (sEMG). There will be 5 assessments during the study (baseline, post-intervention, and at 1 month, 3 months and 6 months of post-intervention). All variables will be collected in every assessment except sEMG that will be recorded at baseline, post-intervention and 3 months post-intervention. For data collection a clinic history of each patient will be complete. Statistical analysis will be done with intention to treat, using the statistic software SPSS 22.0.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 69786 0
Mr JOSUE PLAZA RODRIGUEZ
Address 69786 0
Edificio de Fisioterapia Campus Universitario
Ctra Madrid-Barcelona Km 33,6000 E-28871
Alcala de Henares , Madrid, E-28871
Country 69786 0
Spain
Phone 69786 0
+34664357327
Fax 69786 0
Email 69786 0
[email protected]
Contact person for public queries
Name 69787 0
JOSUE PLAZA RODRIGUEZ
Address 69787 0
Edificio de Fisioterapia Campus Universitario
Ctra Madrid-Barcelona Km 33,6000 E-28871
Alcala de Henares , Madrid, E-28871
Country 69787 0
Spain
Phone 69787 0
+34664357327
Fax 69787 0
Email 69787 0
[email protected]
Contact person for scientific queries
Name 69788 0
JOSUE PLAZA RODRIGUEZ
Address 69788 0
Edificio de Fisioterapia Campus Universitario
Ctra Madrid-Barcelona Km 33,6000 E-28871
Alcala de Henares , Madrid, E-28871
Country 69788 0
Spain
Phone 69788 0
+34664357327
Fax 69788 0
Email 69788 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.