UMIN-CTR Clinical Trial

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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