Evaluating the effectiveness of extracorporeal shockwave therapy on pain reduction and function improvement in chronic achilles tendinopathy patients: a randomized clinical trial.
Aim: Evaluating the effect of shockwave therapy for treatment of chronic Achilles tendinopathy
Inclusion criteria: at least six months of pain and tenderness of the Achilles tendon; existence of a swollen and painful area on the Achilles tendon; having pain along with plantar flexion in the ankle; having pain in the exacerbated dorsiflexion condition in the ankle
Exclusion criteria: Receiving extracorporeal shockwave lithotripsy during the past 6 months; Local injection of steroids during the past 3 months; Having associated diseases such as Polyneuropathy; Patient’s unwillingness to continue the treatment; using another type of treatment; changing the treatment plan based on the physician’s opinion
This study is a double-blind controlled randomized clinical trial.
Sample size: 40 patients who referred to physical rehabilitation clinic of the Isfahan University of Medical Sciences and were divided into two groups of 20
Intervention: Weekly shockwave for 4 weeks for the intervention group and shockwave with no energy for the control group
Expected outcome: Pain reduction and improvement of performance which were measured using VAS and AOFAS methods
Blinding method: One group will receive shock wave with the intended energy and the other with zero energy meaning that the shock wave probe is only placed on the trigger and the sound of shock wave is played but the energy is zero. During the analysis, the researcher would collect the data without knowledge about which of the a or b groups received which treatment. Also, conservative treatment and corrective exercises will be administered for both groups during the study.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016051727907N1
Registration date:2017-07-02, 1396/04/11
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-07-02, 1396/04/11
Registrant information
Name
Hadi Foroozan
Name of organization / entity
Isfahan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 31 3669 1672
Email address
hadi_foroozan@mail.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Isfahan University of Medical Sciences, vice chancellor for research
Expected recruitment start date
2015-03-01, 1393/12/10
Expected recruitment end date
2016-03-01, 1394/12/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluating the effectiveness of extracorporeal shockwave therapy on pain reduction and function improvement in chronic achilles tendinopathy patients: a randomized clinical trial.
Public title
Shock wave therapy for treatment of chronic achilles tendinopathy.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: at least six months of pain and tenderness of the Achilles tendon; existence of a swollen and painful area on the Achilles tendon; having pain along with plantar flexion in the ankle; having pain in the exacerbated dorsiflexion condition in the ankle
Exclusion criteria: Receiving extracorporeal shockwave lithotripsy during the past 6 months; Local injection of steroids during the past 3 months; Having associated diseases such as Polyneuropathy; Patient’s unwillingness to continue or lack of cooperation; using another type of treatment; changing the treatment plan based on the physician’s opinion
Age
From 18 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Patients were randomly allocated into two groups using random numbers table developed by Random Allocation Software
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Isfahan University of Medical Sciences
Street address
Isfahan University of Medical Sciences, Hezar Jerib Street
City
Isfahan
Postal code
7346181746
Approval date
2014-12-10, 1393/09/19
Ethics committee reference number
IR.MUI.REC.1394.3.077
Health conditions studied
1
Description of health condition studied
Achilles tendinopathy
ICD-10 code
M76.60
ICD-10 code description
Achilles tendinitis, unspecified leg.
Primary outcomes
1
Description
Performance
Timepoint
Before intervention/ Immediately after, 1 month and 4 months after intervention.
Method of measurement
The American Orthopedic Foot and Ankle Score
2
Description
Pain
Timepoint
Before intervention/ Immediately after, 1 month and 4 months after intervention.
Method of measurement
Visual Analogue Scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 4 session of shock wave weekly.
Focused: 1500, Energy: 0.25-0.4 Frequency: 2-3 HZ
Radial: 3000, Energy: 1.8-2.6 Frequency: 21Hz
In addition to conservative treatment including: Therapeutic exercise, local massage, and daily use of 100 mg diclofenac sodium for 2 weeks.
Category
Other
2
Description
Control group: 4 session of SHAM shock wave weekly.
Focused: 1500, Energy:0 Frequency: 2-3 HZ
Radial: 3000, Energy: 0 Frequency: 21Hz
In addition to conservative treatment including: Therapeutic exercise, local massage, and daily use of 100 mg diclofenac sodium for 2 weeks.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitaion Clinic, Al-Zahra Hospital
Full name of responsible person
Hadi Foroozan
Street address
Soffeh Avenue
City
Isfahan
2
Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitaion Clinic, Kashani Hospital
Full name of responsible person
Hadi Foroozan
Street address
Kashani Avenue
City
Isfahan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
vice chancellor for research, Isfahan University of Medical Sciences
Full name of responsible person
Mansour Siavash
Street address
Vice Chancellor of Research, Isfahan University of Medical Sciences, Hezar Jerib street
City
Isfahan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
vice chancellor for research, Isfahan University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hadi Foroozan
Position
Resident of Physical Medicine and Reahabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
hadi_foroozan@resident.mui.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
ِBabak Vahdatpour
Position
Assistant Professor
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation, Al-Zahra Hospital
City
Isfahan
Postal code
Phone
+98 31 3668 5555
Fax
Email
vahdatpour@med.mui.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Isfahan University of Medical Sciences
Full name of responsible person
Hadi Foroozan
Position
Resident of Physical Medicine and Rehabilitation
Other areas of specialty/work
Street address
Department of Physical Medicine and Rehabilitation,Al-Zahra Hospital
City
Isfahan
Postal code
Phone
00
Fax
Email
hadi_foroozan@resident.mui.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)