Effects of Lumbosacral Mobility Program on Tight Hamstrings

March 31, 2023 updated by: Riphah International University

Effects of Lumbosacral Mobility Program on Muscle Length in Sedentary Young Adults With Tight Hamstrings

The study will be randomized controlled trial to determine the effects of lumbosacral mobility program on muscle length in sedentary young adults with tight hamstrings. Only the eligible subjects who fulfill the inclusion criteria will be included in the study. A sample of 78 subjects will be taken and randomly allocated into two groups with 39 each. Group A will be given three treatments. Manual therapy, mobility exercise therapy and home based self stretching program. Manual therapy mobilization posterior-anterior glides at lumber facets joints, transverse glides at spinous process & Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy (Single knee to chest, double knee to chest, Lumbar rotation, Lumbar extension, Pelvic tilting). A total of 30 min sessions three times a week on alternate days for 1 week & home-based self-stretches program twice a day for three times a week on alternate days for 1 week. Group B will be given home-based self-stretching program twice a day for three times a week on alternate days for 1 week .The baseline values of all the dependent variable will be recorded on day one and at the end of the 1-week treatment session, using goniometry, active and passive knee extension test, passive straight leg raising and lower extremity functional scale will be used

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The hamstring muscle group consists of four muscles (semitendinosus, semimembranosus, biceps femoris long head, biceps femoris short head). It's a two-joint muscle working simultaneously to act as a hip extensor and knee flexor. It also functions to maintain the stability of the knee joint. The hamstring plays important role in daily activities like running & walking. A lot of factors affecting hamstring function, one of them is flexibility, it is defined as the extent to which muscle length contributes to maximal joint range of motion. It is a well-known muscle of has a shortening tendency. There are many methods for treating hamstrings flexibility/tightness/shortening. Routinely, physiotherapists are using stretching & strengthening exercises, instruments assisted in soft tissue mobilization. The current study focuses on two treatments manual therapy & lumber mobility exercises

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
78

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Pnjab
      • Lahore, Pnjab, Pakistan
        • FMH Institute of allied health sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age 20-30 years
  • Sedentary life style
  • BMI < 23 non-obese
  • Hamstring shortness ≥ 20° using the active knee extension test (aket)
  • No history of orthopedic/neurologic disorders in the lower extremity
  • No history of back pain in last 2 weeks
  • No contraindication for using manual therapy
  • No joint limitation in the lower extremities

Exclusion Criteria:

  • Any systemic soft tissue and bony disease
  • Fracture
  • Neuropathy
  • Congenital deformities of spine

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mobilization
Lumbosacral manual therapy mobilization
Other: Lumbosacral manual therapy mobilization, lumber mobility exercises and home based self strechings program.
Manual therapy, mobility exercise therapy and a home-based self-stretching program. Manual mobilization postero-anterior glides at lumber facets joints, Transverse glides at spinous process & Posterior-anterior glides at SI joint. Glides will be performed 3 times with 5 repetitions. Mobility exercise therapy.
Other: Stretching program
home based self strechings program
Other: home based self strechings program only.
Home based self-stretching program includes 3 repetitions of 15 seconds duration stretch (with 20 seconds rest between each repetition). Repeat stretching exercises twice a day for 3 alternate days for 1 week. Piriformis stretch: in supine crook lying, placing the lateral side of the foot over the contralateral knee and pulling towards the chest with the hands. Quadriceps stretch: stand on your left leg, one knee touching the other, hold a chair or the wall to keep you steady if needed, grab your right foot, using your right hand, and pull it towards your butt. Hamstring stretch: To stretch the right leg, sit on the ground with the left leg bent at the knee with the foot facing inward. This is called the butterfly position. Extend the right leg, keeping it slightly bent at the knee. Bend forward at the waist, making sure to keep the back straight.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Active knee extension test
Time Frame: 1 Week
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) subject were asked to extens the knee until stretch sensation felt ayt posterior aspect of thigh. Note the range with goniometer
1 Week
Passive knee extension test
Time Frame: 1 Week
A reliable tool for hamstring length measurement. Subject is in supine lying position on examination table while other leg is in extension position stabilized with two strap. One across midthigh and other across pelvis ( to prevent compensatory movements ) now passively extend subject's knee until stretch sensation felt at posterior aspect of thigh. Note the range with goniometer.
1 Week
Goniometry
Time Frame: 1 Week
It is an affordable & available tool for measurement of joint range of motion in degrees. (18) Passive Straight Leg Raise (SLR) test Subject is asked to maintain a position of supine lying on examination bed. Then passive SLR is performed by lifting subject heel. ( knee remains in extension ) pelvis should remain stabilize. look for the point at which discomfort starts. Note the range.
1 Week
LEFS
Time Frame: 1 Week
It is well known validated tool used to assess the functioning of lower extremity. It's a 20 question test which further subgroups into 4. Questions based on physical activity of lower extremity
1 Week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Riphah International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 30, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 30, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 23, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 23, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 3, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 31, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REC/RCR & AHS/ 22/0138 Kanwal

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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