Evaluation of the added effect of quadriceps dry needling on knee range of motion and pain in the primary phase of rehabilitation after anterior cruciate ligament reconstruction
Evaluation of the added effect of quadriceps dry needling on knee range of motion and pain in the primary phase of rehabilitation after anterior cruciate ligament reconstruction
Design
This study is a randomized clinical trial. Firstly, subjects get familiar with the methods, fill the consent form and characteristics form and then will be assigned into two groups by blocking randomization. Both groups receive routine physiotherapy treatments, but one group receive a real dry needle and the other group receive a sham dry needle for quadriceps muscle. Patients will be treated for four weeks (12 sessions) and dry needling will be received for four sessions (once each week). Knee range of motion and pain intensity will be assessed as outcome measures.
Settings and conduct
This study will be conducted in sport physiotherapy clinics of Shiraz and the suburbs. The assessor of knee pain and range of motion is unaware of subjects allocation into the groups of the study
Participants/Inclusion and exclusion criteria
inclusion criteria:
Athletes from 18 to 45 years old undergoing ACL surgery using hamstring grafts for surgery, knee flexion of 90 degrees or less when referring to physiotherapy clinic (2 weeks after surgery), level 6 to 9 according to Tagner Questionnaire
exclusion criteria:
contraindications of the dry needle including fear of needle, diabetes, using anticoagulant drugs, and etc., any history of lower limb disorder or fracture prior to surgery that had limited knee range of motion, neuropathic pain or acute phase of local infection in lower extremity
Intervention groups
Intervention group 1: 12 sessions of routine knee physiotherapy and four sessions of quadriceps dry needle
Intervention group 2: 12 sessions of routine knee physiotherapy and four sessions of quadriceps sham dry needle
Main outcome variables
Knee range of motion
pain intensity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181209041898N1
Registration date:2019-02-26, 1397/12/07
Registration timing:prospective
Last update:2019-02-26, 1397/12/07
Update count:0
Registration date
2019-02-26, 1397/12/07
Registrant information
Name
Siroos Keramati fahliani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 4260 0271
Email address
sirooskeramati@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-05-22, 1398/03/01
Expected recruitment end date
2019-08-28, 1398/06/06
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the added effect of quadriceps dry needling on knee range of motion and pain in the primary phase of rehabilitation after anterior cruciate ligament reconstruction
Public title
The effect of the dry needle on pain and range of motion after anterior cruciate ligament reconstruction
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18 to 45 years
Athletes with knee anterior cruciate ligament injury that is created during sportive activities
undergoing ACL surgery and being referred to physiotherapy by a specialist, within two weeks after surgery
using hamstring grafts for surgery
knee flexion of 90 degrees or less when referring to physiotherapy clinic (2 weeks after surgery)
level 6 to 9 according to Tagner Questionnaire
Exclusion criteria:
contraindications of the dry needle including fear of needle, diabetes, using anticoagulant drugs, and etc.
any history of lower limb disorder or fracture prior to surgery that had limited knee range of motion
Neuropathic pain or acute phase of local infection in lower extremity
Age
From 18 years old to 45 years old
Gender
Male
Phase
N/A
Groups that have been masked
Participant
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted Block Randomization. Randomization was achieved with an online randomization application to provide random permuted blocks with a block size of 4.
Blinding (investigator's opinion)
Single blinded
Blinding description
Participants will be kept blinded to allocation to real or sham dry needling groups
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shiraz University of Medical Sciences
Street address
Vice-Chancellor for Research, Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Approval date
2018-12-08, 1397/09/17
Ethics committee reference number
IR.SUMS.REHAB.RES.1397.004
Health conditions studied
1
Description of health condition studied
Athletes who performed anterior cruciate ligament reconstruction surgery
ICD-10 code
S83.5
ICD-10 code description
Sprain of cruciate ligament of knee
Primary outcomes
1
Description
Knee range of motion
Timepoint
at the beginning of the study and 7, 14, 21, and 28 days after the initiation of treatment
Method of measurement
Goniometery
Secondary outcomes
1
Description
pain intensity
Timepoint
at the beginning of the study and 7, 14, 21, and 28 days after the initiation of treatment
Method of measurement
Numerical rating scale of pain
Intervention groups
1
Description
Intervention group 1: receiving 12 sessions (four weeks) of routine knee physiotherapy and one session of quadriceps dry needle in each week
Category
Rehabilitation
2
Description
Intervention group 2: receiving 12 sessions (four weeks) of routine knee physiotherapy and one session of quadriceps sham dry needle in each week
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
sport physiotherapy clinics of Shiraz and the suburbs
Full name of responsible person
Siroos Keramati
Street address
Shiraz University of Medical Sciences, Zand Blvd., Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
info@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Younes Ghasemi
Street address
Floor 7, Center Bilding of Shiraz Univercity of Medical Science