UMIN-CTR Clinical Trial

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

Hamstring tightness.

Classification by specialty

Rehabilitation medicine

Adult

Classification by malignancy

Others

Genomic information

NO

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

Primary outcomes

Active knee extension (AKE)
Passive straight leg raise test (PSLR)

Key secondary outcomes

Sit and reach test (SRT)

Study type

Interventional

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

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

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

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

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

Institute

Amity Institute of Physiotherapy

Institute

Department

Personal name

Organization

NA-Self

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

India

Co-sponsor

NA

Name of secondary funder(s)

NA

Organization

Amity Institute of Physiotherapy

Address

F1 LGF, AIPT, AUUP, Noida, India, 201313

Tel

0120-4392000

Email

mshukla@amity.edu

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Amity Institute of Physiotherapy
A+ Orthopaedic centre

Date of disclosure of the study information

2021

Year

01

Month

10

Day

URL releasing protocol

NA

Publication of results

Unpublished

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

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 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).

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