Gluteal Activation With or Without Traction Straight Leg Raise Technique

December 7, 2022 updated by: Riphah International University

Effects of Gluteal Activation With or Without Traction Straight Leg Raise Technique Among Patients of Sacroiliac Joint Syndrome

This study was a Randomized clinical trial conducted to determine the Effects of gluteal activation with or without traction straight leg raise technique among patients of sacroiliac joint syndrome so that in future this study will be helpful for other clinician to determine that how much gluteal activation is important in low back pain or sacroiliac joint syndrome, and how it affects our sling system.

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

Non Probability Convenient sampling was done . Patients following eligibility criteria from Sports and Spine Professionals ,Lahore were considered. Sample size was calculated with Epi tool calculator. 38 Participants were randomly allocated in two groups equally via convenient sampling method. Baseline assessment was done initially. Group A was given gluteal activation exercises with traction straight leg raise technique for hamstring and Group B was gluteal activation exercises without traction straight leg raise technique for hamstring. Duration of research was almost 6 months. Patient will undergo 10 treatments in five weeks. Each session will take 30 minutes. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via sphygmomanometer and numeric pain rating scale for assessing muscle strength of gluteus maximum and pain levels respectively. All participants were provided written informed consent prior to commencement of the procedures. They were free to quit the treatment at any stage of research. Data was analyzed by using SPSS version 23.

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.
38

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
      • Lahore, Pakistan, 54000
        • Riphah IU

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

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Subjects with LBP below the level of L5,
  2. With pain over the posterior aspect of SI joint around posterior superior iliac spine and buttock with or without above knee leg pain.
  3. Females only

Exclusion Criteria:

  1. Had radicular pain with neurological (sensory or motor) deficits,
  2. Had a history of spinal surgery, spinal, pelvic, or lower extremity fracture; hospitalization for trauma or motor vehicle accident;
  3. Hip or knee dysfunctions;
  4. Pregnancy;
  5. Any systemic disease such as arthritis, tuberculosis, liver, or kidney failure
  6. Subjects with leg length discrepancies, because of its potential effect on hamstring muscle length were also excluded. -

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: Traction straight leg raise technique for hamstring.
Experimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions along with traction straight leg raise technique. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus.
Other: Traction straight leg raise technique for hamstring
traction straight leg raise technique is used along with gluteal exercises
Experimental: Gluteal activation exercises
Experimental group underwent conventional physiotherapy treatment (hot pack) followed by five main gluteal activation exercises three in first five sessions and rest two in remaining five sessions. Each session took 30 minutes . Participants were treated 10 times over a 5 week period with 2 treatment sessions per week. Pre and Post treatment readings were taken in 1st and 10th session over a 5 week period respectively. Assessment was done via Numeric pain rating scale and sphygmomanometer for assessing pain intensity and muscle strength of gluteus maximus.
Other: Gluteal activation exercises,Hotpack
only gluteal activation exercises were performed without traction straight leg raise technique

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
Change of muscle strength of gluteus maximum by "Sphygmomanometer"
Time Frame: Baseline at 1st session on 1st week,at 10th sessions on 5th week
change in strength of gluteal muscle was checked at 1st session and then follow up at end of 10th session
Baseline at 1st session on 1st week,at 10th sessions on 5th week

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
change in pain by "Numeric Pain rating Scale"
Time Frame: Baseline at 1st session on 1st week , at 10th session on 5th week
change in pain intensity was checked at 1st session and then follow up at end of 10th session
Baseline at 1st session on 1st week , at 10th session on 5th 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.
October 15, 2021

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.
July 31, 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.
July 31, 2022

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).
February 5, 2021

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.
February 16, 2021

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.
February 17, 2021

Study Record Updates

Last Update Posted (Estimate)

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.
December 8, 2022

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.
December 7, 2022

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.
December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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/LHR/20/0103 Farzana Saqib

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings