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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000042960
Receipt No. 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

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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
Email 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
Email mshukla@amity.edu

Sponsor
Institute Amity Institute of Physiotherapy
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049044

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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