The aim was investigation of low level laser on flexor tendon repair.
In a randomized controlled trial, between April and September 2015, 39 patients with flexor tendon injury in the first 3 zones of their hand in 15Khordad hospital were enrolled for low level laser therapy randomized (just in odd days). Sample size was 96 fingers in two of low level laser and controlled groups. The end examination was double blind in clinical trial phase II. They got 8-10 session low level laser therapy with red and infrared lasers over flexor tendon repaired area. Red laser was continuous, 660 nm, and 2J/cm2. Infra red laser was pulse wave, 810 nm, 100 Hz, 5.85 J/cm2. Patients were visited in days 28-32 of surgery. Passive range of motion (PROM) was examined as double blind in 28 days. Underling diseases with impairment repair as diabetes or rheumatoid and extensor tendons simultaneously or under 10 years, were excluded. The only intervention was low level laser. Primary outcome variables was finger range of motion. Secondary outcome variables were pain and edema.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017050233783N1
Registration date:2017-06-20, 1396/03/30
Registration timing:retrospective
Last update:
Update count:0
Registration date
2017-06-20, 1396/03/30
Registrant information
Name
Masoud Yavari
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21889021559
Email address
m_yavari@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research project Shahid Beheshti University, Medical science.
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigation of the effect of Low Level Laser therapy on repair of human digital flexor tendon repair
Public title
Early low level laser therapy improved passive range of motion and decreased pain in patients with flexor tendon injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusive criteria: All patients with hand injuries in 15khordad hospital at emergency department.
Exclusion criteria: Underling diseases with impairment repair as diabetes or rheumatoid arthritis; multiple injuries to one flexor tendon; injuries to bone and extensor tendons simultaneously; skin loss; non compliant patients or under 10 years; gross contaminations of wounds.
Age
From 15 years old to 63 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
92
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shahid Beheshti University of Medical Sciences
Street address
Near the Hospital Ayatollah Taleqani, Shahid Arabi Street, Yemen Street, Chamran Highway, Tehran, Iran
City
Tehran
Postal code
1985717443
Approval date
2015-05-17, 1394/02/27
Ethics committee reference number
SBMU.REC.1394.9
Health conditions studied
1
Description of health condition studied
Injury of flexor tendon of other finger at hand level
ICD-10 code
S66.1
ICD-10 code description
Injury of flexor muscle and tendon of other finger at wrist and hand level
Primary outcomes
1
Description
range of motion
Timepoint
end of survey
Method of measurement
ruler
Secondary outcomes
1
Description
pain
Timepoint
after of every low level laser session and end of survey
Method of measurement
questionnaire, 1 to 10 scale
2
Description
edema
Timepoint
end of survey
Method of measurement
centimeter
Intervention groups
1
Description
Intervention group: Irradiation of low level laser in the first to fourth weeks of injury in 8-10 sessions on wound region. Red laser in continuous mode, 660 nm, and 2J/cm2. Infra red laser in pulsed mode, wave 810 nm, 100 Hz, 5.85 J/cm2