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Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction (HVLA)

Primary Purpose

Manipulation, Psychologic, Pain, Performance Anxiety

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Comparing to Manipulation and Myofascial Release Techniques
Sponsored by
Alanya Alaaddin Keykubat University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Manipulation, Psychologic

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Volunteer Being between the ages of 18-45, Not to have any psychological, neurological, orthopedic and rheumatic disorders, Not having any other musculoskeletal pathology affecting the lower extremities, Not having undergone spine and/or lower extremity surgery, Those with mechanical sacroiliac joint pain, 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: Being under the age of 18 and over the age of 45, Having any psychological, neurological, orthopedic and rheumatic disorders, Pregnancy and suspicion of pregnancy, Having active malignancies, Having an active infection, Injection and operation of the sacroiliac joint in the last 3 months, Having drug or substance addiction, Central vascular/neurological conditions

Sites / Locations

  • Ayça ARACI

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Active Comparator

Sham Comparator

Arm Label

Group I

Group II

Group III

Group IV

Arm Description

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,

Group IV (n=14) underwent sham manipulation as the control group

Outcomes

Primary Outcome Measures

Visual Analog Scale
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 Sit and Reach Test
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.
The Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance
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
The Optojump Next system (Via Stradivari, Bolzano) for multiple jump tests,
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
MicroFet2 digital hand dynamometer
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.

Secondary Outcome Measures

Full Information

First Posted
October 3, 2023
Last Updated
October 17, 2023
Sponsor
Alanya Alaaddin Keykubat University
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1. Study Identification

Unique Protocol Identification Number
NCT06089772
Brief Title
Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction
Acronym
HVLA
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
June 1, 2023 (Actual)
Primary Completion Date
July 31, 2023 (Actual)
Study Completion Date
August 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alanya Alaaddin Keykubat University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Manipulation, Psychologic, Pain, Performance Anxiety, Participation, Patient, Physiotherapists

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I
Arm Type
Experimental
Arm Description
Group I (n=14) received HVLA spinal manipulation
Arm Title
Group II
Arm Type
Active Comparator
Arm Description
Group II (n=14) underwent foam roller stretching,
Arm Title
Group III
Arm Type
Active Comparator
Arm Description
Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching,
Arm Title
Group IV
Arm Type
Sham Comparator
Arm Description
Group IV (n=14) underwent sham manipulation as the control group
Intervention Type
Other
Intervention Name(s)
Comparing to Manipulation and Myofascial Release Techniques
Intervention Description
Randomized Controlled Trials
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
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.
Time Frame
Baseline - right after the intervention
Title
Baseline Sit and Reach Test
Description
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.
Time Frame
Baseline - right after the intervention
Title
The Optojump Next system (Via Stradivari, Bolzano) for vertical jump performance
Description
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
Time Frame
Baseline - right after the intervention
Title
The Optojump Next system (Via Stradivari, Bolzano) for multiple jump tests,
Description
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
Time Frame
Baseline - right after the intervention
Title
MicroFet2 digital hand dynamometer
Description
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.
Time Frame
Baseline - right after the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Volunteer Being between the ages of 18-45, Not to have any psychological, neurological, orthopedic and rheumatic disorders, Not having any other musculoskeletal pathology affecting the lower extremities, Not having undergone spine and/or lower extremity surgery, Those with mechanical sacroiliac joint pain, 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: Being under the age of 18 and over the age of 45, Having any psychological, neurological, orthopedic and rheumatic disorders, Pregnancy and suspicion of pregnancy, Having active malignancies, Having an active infection, Injection and operation of the sacroiliac joint in the last 3 months, Having drug or substance addiction, Central vascular/neurological conditions
Facility Information:
Facility Name
Ayça ARACI
City
Alanya
State/Province
Antalya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction

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