UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042960 |
|---|---|
| Receipt number | R000049044 |
| Scientific Title | Comparative study of three different techniques to increase active and passive hamstring flexibility - a randomized controlled trial. |
| Date of disclosure of the study information | 2021/01/10 |
| Last modified on | 2021/01/10 00:27:31 |
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Basic information
Public title
Stretching exercises for Hamstring group of muscles.
Acronym
Stretching exercises.
Scientific Title
Comparative study of three different techniques to increase active and passive
hamstring flexibility - a randomized controlled trial.
Scientific Title:Acronym
Comparative study for three stretching techniques - RCT.
Region
| Asia(except Japan) |
Condition
Condition
Hamstring tightness.
Classification by specialty
| Rehabilitation medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The purpose of this study was to compare the effectiveness of Static stretching, Cupping
therapy and Self Myofascial release, on active and passive flexibility of hamstring muscle group using AKE, PSLR and SRT.
Basic objectives2
Others
Basic objectives -Others
Active versus passive comparison.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Active knee extension (AKE)
Passive straight leg raise test (PSLR)
Key secondary outcomes
Sit and reach test (SRT)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Maneuver |
Interventions/Control_1
Self-Myofascial release-The participant assumed a long sitting position on a firm and even surface by placing the
arms backward and loading body weight on the palms. A foam roller was placed under the
hamstrings and slowly moved back and forth from the ischial tuberosity to the popliteus, by
applying pressure for 4 minutes (2 min for each leg) for 3 days at the same time of day at 24
hour interval
Interventions/Control_2
Cupping therapy-The cupping technique involved the static cupping
application for 7 minutes. The cupping intervention was performed using JINKANG B242
Cupping set. The participant lie down in prone position, a thin layer of lotion was applied to
the hamstring and cups are placed on the trigger point. The assigned intervention was applied bilaterally to all participants and they were asked to
continue their normal weekly exercise or activity routine. Follow up measurement was taken
after 1 week of intervention.
Interventions/Control_3
Static stretching -Participants were in supine lying position with tested leg in active knee extension test position,
therapist passively extend the knee until the participant feels the intolerable stretch. This
procedure was repeated for 3 times with 30 sec hold and 10 seconds interval in between each
stretch for consecutive 5 days and follow up was taken on 8 th day
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 30 | years-old | > |
Gender
Male and Female
Key inclusion criteria
BMI between 18.5-24.9, hamstring are tight and passive SLR range between 30-70, at
least 15-20 degree loss of knee extension when hip held in 90 degree flexion, participants with
less than 12 inches in Sit and reach test and Stretch end feel during complete range of motion
Key exclusion criteria
past history of hamstring injury within 2 years, Low joint mobility or
hypermobility, Metabolic disease, Incomplete post fracture bone fusion, Lumbar and lower
limb neurological compromise, Limb length discrepancy, Acute joint pain with exercise,
Straight leg, hip flexion range of motion was greater than 70 degree. Ethical approval for this
randomised study was granted by, NTCC committee of AIPT, AUUP, A+ orthopaedic and
sports Med Centre. Informed consent was obtained from all participants and any relevant
questions answered on data collection, all concerned were aware of the right to withdraw from
the study at any time.
Target sample size
45
Research contact person
Name of lead principal investigator
| 1st name | Mayank |
| Middle name | - |
| Last name | Shukla |
Organization
Amity Institute of Physiotherapy, Amity University, UP
Division name
Uttar Pradesh Noida
Zip code
201303
Address
F1 LGF Sector 125, Noida UP India
TEL
01204392000
mshukla@amity.edu
Public contact
Name of contact person
| 1st name | Mayank |
| Middle name | |
| Last name | Shukla |
Organization
Amity Institute of Physiotherapy, Amity University, UP
Division name
Uttar Pradesh Noida
Zip code
201303
Address
F1 LGF Sector 125, Noida UP India
TEL
911204392000
Homepage URL
https://www.amity.edy/aipt
mshukla@amity.edu
Sponsor or person
Institute
Amity Institute of Physiotherapy
Institute
Department
Personal name
Funding Source
Organization
NA-Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
India
Other related organizations
Co-sponsor
NA
Name of secondary funder(s)
NA
IRB Contact (For public release)
Organization
Amity Institute of Physiotherapy
Address
F1 LGF, AIPT, AUUP, Noida, India, 201313
Tel
0120-4392000
mshukla@amity.edu
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Amity Institute of Physiotherapy
A+ Orthopaedic centre
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
NA
Publication of results
Unpublished
Result
URL related to results and publications
NA
Number of participants that the trial has enrolled
48
Results
result show different effects. Passive interventions affect passive flexibility. Active interventions increase active flexibility.
Results date posted
| 2021 | Year | 01 | Month | 10 | Day |
Results Delayed
Results Delay Reason
na
Date of the first journal publication of results
Baseline Characteristics
Table 2 Showing mean and standard deviation of different groups with descriptive
parameters. To summarize, this table shows mean and standard deviation of various
parameters like, age, height, weight and BMI of GROUP-1, GROUP-2 and GROUP-3.
Mean age was 21.66 to 25.13
BMI was less than 24.9.
Participant flow
N=60 assessed, 48 selected & randomized
15 excluded
45 randomized completed study
Adverse events
NA
Outcome measures
AKE
PSLR
SRT
Plan to share IPD
Publication is planned
IPD sharing Plan description
Publication is planned
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 01 | Month | 10 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 08 | Day |
Anticipated trial start date
| 2020 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2020 | Year | 07 | Month | 30 | Day |
Date of closure to data entry
| 2020 | Year | 08 | Month | 03 | Day |
Date trial data considered complete
| 2020 | Year | 08 | Month | 03 | Day |
Date analysis concluded
| 2020 | Year | 10 | Month | 10 | Day |
Other
Other related information
The study was completed in the year 2020, and publication is planned in 2021. Results are not getting entered in the section given - One-way ANOVA in the follow-up analysis of three groups has shown a
significant variation in the AKE (p= 0.013*), and PSLR (p= 0.019*). In parallel analysis
using unpaired t test - post intervention analysis , SRT has shown better result for
SMFR versus SS (p = 0.018), AKE has shown better result for SS versus CTh
(p=0.043), and PSLR has shown better result for CTh versus SMFR (p=0.02); followup analysis , SRT has shown better result for SMFR versus SS (p=0.04), and SMFR
versus CTh (p=0.012), AKE has shown better results for SMFR versus SS (p= 0.045 ),
and SMFR versus CTh (p=0.0035 ), PSLR has shown better results for CTh versus
SMFR (p= 0.004), and SS versus SMFR (p= 0.025).
Management information
Registered date
| 2021 | Year | 01 | Month | 10 | Day |
Last modified on
| 2021 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049044
