Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12617000259347
Ethics application status
Approved
Date submitted
18/11/2016
Date registered
20/02/2017
Date last updated
20/02/2017
Type of registration
Prospectively registered

Titles & IDs
Public title
Dry Needling After Anterior Cruciate Ligament Reconstruction
Scientific title
Effect of deep dry needling treatment on range of motion in hamstrings of patients after anterior cruciate ligament reconstruction versus a conventional manual physical therapy protocol.
Secondary ID [1] 290582 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Knee surgery 301036 0
Pain 301037 0
Mechanical changes 301038 0
Range of motion 301305 0
Condition category
Condition code
Physical Medicine / Rehabilitation 300825 300825 0 0
Physiotherapy
Musculoskeletal 301058 301058 0 0
Other muscular and skeletal disorders
Injuries and Accidents 301059 301059 0 0
Other injuries and accidents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
-Deep dry needling treatment with acupuncture needle in Myofascial Trigger Point of hamstrings of the leg which has been operated, once a week for 6 month. The duration of dry needling treatment it´s five minutes and it will be realized in CEMTRO´S clinic gym. Dry needling will be make once a week before the manual physical therapy protocol by a physical therapist .
- Manual therapy protocol based on massage and stretching of stabilize muscles of knee, mobilization of knee in flexion and extension movement,Treatment will be realized five days a week for 6 months by a physical therapist in CEMTRO´S clinic gym. The duration of each session of treatment it´s half an hour.
Dry needling and manual physical therapy protocol will be in the same period of 6 month.
-Evaluation of pain with visual analogic scale
- Evaluation of functionality
-Evaluation of range of motion.
Treatment and evaluation will be carried out by a Physical therapist.
We will collect the information obtained and the registration of visits in an diary and excel program.
Intervention code [1] 296443 0
Rehabilitation
Intervention code [2] 296629 0
Treatment: Other
Comparator / control treatment
- Manual therapy protocol based on massage and stretching of stabilize muscles of knee, mobilization of knee in flexion and extension movement,Treatment will be realized five days a week for 6 months by a physical therapist in CEMTRO´S clinic gym. Each session of treatment will go on for a half an hour.
-Evaluation of pain with visual analogic scale
- Evaluation of functionality
-Evaluation of range of motion.
Treatment and evaluation will be carried out by a Physical therapist.
We will collect the information obtained and the registration of visits in an diary and excel program.
Control group
Active

Outcomes
Primary outcome [1] 300249 0
Range of motion at the knee measured by goniometer
Timepoint [1] 300249 0
Before start the treatment, 1 week after and once a month during 6 months after the surgery.
Secondary outcome [1] 329492 0
Knee pain measured by visual analog scale(VAS)
Timepoint [1] 329492 0
Before start the treatment, 1 week after and once a month during 6 months after the surgery.
Secondary outcome [2] 329493 0
Knee functionality measured by Lysholm scale.
Timepoint [2] 329493 0
Before start the treatment, 1 week after and once a month during 6 months after the surgery.

Eligibility
Key inclusion criteria
- Patiens who has been operated to reconstruct anterior ligament cruciate.
- Patiens in whom there is evidence of a loss flexibility of hamstring
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Patiens who has received dry needling in the same leg one week before surgery.
- Patiens with sensitive alteration
- Patiens with different injuries which can cause dysfunction in lower limbs like degenerative diseases, acute medical processes or neurological diseases
- Fear of needles
- Coagulation problems

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2017
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
46
Accrual to date
Final
Recruitment outside Australia
Country [1] 8404 0
Spain
State/province [1] 8404 0
Madrid

Funding & Sponsors
Funding source category [1] 295011 0
University
Name [1] 295011 0
Alcala de Henares University
Country [1] 295011 0
Spain
Primary sponsor type
University
Name
Alcala de Henares University
Address
Physical therapy building, University of Alcala de Henares.
Highway Madrid-Barcelona km 33
Alcala de Henares, Madrid
28871
Country
Spain
Secondary sponsor category [1] 293829 0
Hospital
Name [1] 293829 0
CEMTRO
Address [1] 293829 0
Av del Ventisquero de la Condesa 42
28035
Madrid
Country [1] 293829 0
Spain

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 296365 0
Alcala de Henares
Ethics committee address [1] 296365 0
Ethics committee country [1] 296365 0
Spain
Date submitted for ethics approval [1] 296365 0
Approval date [1] 296365 0
14/11/2016
Ethics approval number [1] 296365 0
CEIM/HU/2016/15

Summary
Brief summary
Controlled, randomized, single-blind clinical trial with subjects undergoing of the anterior cruciate ligament who receive physical therapy in the Rehabilitation Service of CEMTRO Clinic in Madrid.
The primary aim of this study is know which are the mechanical changes of dry needling in the hamstring muscles of patient who have been operated on anterior cruciate ligament. We will observe the effects in terms on knee´s range of joint mobility, pain and functionality.
Our hypothesis is based on the dry needling can improve the recovery of this kind of patient.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 70606 0
Miss Maria Cofino Lora
Address 70606 0
Alcala de Henares University
Ctra. Madrid-Barcelona Km 33,600.
Alcala de Henares 28871
Madrid (Spain)
Country 70606 0
Spain
Phone 70606 0
+34 630721287
Fax 70606 0
Email 70606 0
maria.cofino.lora@gmail.com
Contact person for public queries
Name 70607 0
Miss Montana Requejo Pulido
Address 70607 0
Alcala de Henares University
Ctra. Madrid-Barcelona Km 33,600.
Alcala de Henares 28871
Madrid (Spain)
Country 70607 0
Spain
Phone 70607 0
+34 618266664
Fax 70607 0
Email 70607 0
mrequejop@gmail.com
Contact person for scientific queries
Name 70608 0
Miss Monica Fernandez Navarro
Address 70608 0
Alcala de Henares University
Ctra. Madrid-Barcelona Km 33,600.
Alcala de Henares 28871
Madrid (Spain)
Country 70608 0
Spain
Phone 70608 0
+34 619476555
Fax 70608 0
Email 70608 0
monica.fernandezn@gmail.com

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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