Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction (HVLA)

October 17, 2023 updated by: Ayça Araci, Alanya Alaaddin Keykubat University

A Comparison Of The Effects Of High-Velocity Low-Amplitude (Hvla) Manipulation And Myofascial Release Technique On Performance In Healthy Individuals With Sacroiliac Joint Dysfunction

Aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and myofascial release techniques on performance in healthy individuals with sacroiliac joint dysfunction.

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

Aim: aimed to compare the effects of High-Velocity Low-Amplitude (HVLA) manipulation and myofascial release techniques on performance in healthy individuals with sacroiliac joint dysfunction. Design: Randomized control trial. Setting: University physiotherapy clinic. Participiants: Participants aged 18-45 years with confirmed Dysfunction by six clinical Sacroiliac Joint diagnostic tests. Intervention: The groups determined as randomly into the four groups. Group I (n=14) received HVLA spinal manipulation, Group II (n=14) underwent foam roller stretching, Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching, and Group IV (n=14) underwent sham manipulation as the control group. Measures were measured before the acute intervention and right after the intervention. Outcomes: Prior to the interventions, participants were evaluated using the Visual Analog Scale (VAS) for pain assessment, the Baseline Sit and Reach test for flexibility assessment, the Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance and multiple jump tests, and the MicroFet2 digital hand dynamometer (United States, Utah) for muscle strength measurement. Results: The study groups showed statistically significant improvements in performance parameters compared to the control group (p<0.05). Pre-treatment and post-treatment performance parameters and pain values were statistically significant in both groups (p<0.05). While performance improvements were observed in all four groups, the highest changes were generally observed in the HVLA + Myofascial release group. Conclusion: Considering the overall results, the combined use of HVLA and Myofascial release in the treatment protocol is recommended.

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.
56

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

  • Turkey
    • Antalya
      • Alanya, Antalya, Turkey
        • Ayça ARACI

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

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Volunteer
  2. Being between the ages of 18-45,
  3. Not to have any psychological, neurological, orthopedic and rheumatic disorders,
  4. Not having any other musculoskeletal pathology affecting the lower extremities,
  5. Not having undergone spine and/or lower extremity surgery,
  6. Those with mechanical sacroiliac joint pain,
  7. Patients in whom at least 3 out of 6 provocation tests showing sacroiliac joint dysfunction and validity-reliability studies were positive: 1. Distraction, 2. Compression, 3. Gaenslen, 4. Posterior friction test, 5. Sacral thrust, 6. Faber (8) Individuals with sacroiliac pain at least 3 points on the VAS in the last 1 month 11

Exclusion Criteria:

  1. Being under the age of 18 and over the age of 45,
  2. Having any psychological, neurological, orthopedic and rheumatic disorders,
  3. Pregnancy and suspicion of pregnancy,
  4. Having active malignancies,
  5. Having an active infection,
  6. Injection and operation of the sacroiliac joint in the last 3 months,
  7. Having drug or substance addiction,
  8. Central vascular/neurological conditions

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: None (Open Label)

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: Group I
Group I (n=14) received HVLA spinal manipulation
Other: Comparing to Manipulation and Myofascial Release Techniques
Randomized Controlled Trials
Active Comparator: Group II
Group II (n=14) underwent foam roller stretching,
Other: Comparing to Manipulation and Myofascial Release Techniques
Randomized Controlled Trials
Active Comparator: Group III
Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching,
Other: Comparing to Manipulation and Myofascial Release Techniques
Randomized Controlled Trials
Sham Comparator: Group IV
Group IV (n=14) underwent sham manipulation as the control group
Other: Comparing to Manipulation and Myofascial Release Techniques
Randomized Controlled Trials

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
Visual Analog Scale
Time Frame: Baseline - right after the intervention
Pain Level Measurement - When reading the VAS, the position of the respondent's cross is generally assigned a score between 0 and 100. If documented in paper form, the scores can then be simply transferred to a 100-value scale using a millimeter tape measure. The division into hundredths is considered sufficiently sensitive.
Baseline - right after the intervention
Baseline Sit and Reach Test
Time Frame: Baseline - right after the intervention
Flexibility - A standard SR box was placed on the floor by placing tape at a right angle to the 38 cm mark. The participants sat on the floor with shoes on and fully extended one leg so that the sole of the foot was flat against the end of the box. They then extended their arms forward, placing one hand on top of the other. With palms down, they reached forward, sliding hands along the measuring scale as far as possible without bending the knee of the extended leg. Throughout testing, the physiotherapist (NU) heel remained at the 45 cm mark.
Baseline - right after the intervention
The Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance
Time Frame: Baseline - right after the intervention
Participants were positioned in a mini squat with arms held back, starting from the initial position. Participants were instructed to perform 3 consecutive vertical jumps, lifting their arms upward from the front. The average of the three measurements was calculated for jump performance and recorded in centimeters. Glatthorn et al., (2011) reported an interrater reliability ICC value between 0.997 and 0.998 for the Optojump Next device in estimating vertical jump height
Baseline - right after the intervention
The Optojump Next system (Via Stradivari, Bolzano) for multiple jump tests,
Time Frame: Baseline - right after the intervention
Upon the practitioner's 'start' command, participants continuously jumped vertically for 15 seconds, maintaining their knees extended and hands free. At the end of the test, using the computer and camera connected to the measurement device, values (jump count, contact time, airborne time, height, power, step) were recorded
Baseline - right after the intervention
MicroFet2 digital hand dynamometer
Time Frame: Baseline - right after the intervention
Muscle strength measurement was performed for the hamstring, gastrocnemius, and soleus muscles. For muscle strength measurement, the MicroFet2 digital handheld dynamometer (United States, Utah) was used 17. To ensure maximum isometric contraction for each muscle group, the application was repeated 3 times, with each contraction held for 5 seconds, and there were 15-second breaks between repetitions 18,19Participants were briefed about the procedures and were given 2 practice trials. After the practice trials, a 1-minute break was given before the actual measurements began.
Baseline - right after the intervention

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.
Alanya Alaaddin Keykubat University

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.
June 1, 2023

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, 2023

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.
August 15, 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).
October 3, 2023

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.
October 17, 2023

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.
October 18, 2023

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.
October 18, 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.
October 17, 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.
October 1, 2023

More Information

Terms related to this study

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.
  • 61351342

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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