- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06089772
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
56
Phase
- 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
-
-
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
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: Group I
Group I (n=14) received HVLA spinal manipulation
|
Randomized Controlled Trials
|
|
Active Comparator: Group II
Group II (n=14) underwent foam roller stretching,
|
Randomized Controlled Trials
|
|
Active Comparator: Group III
Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching,
|
Randomized Controlled Trials
|
|
Sham Comparator: Group IV
Group IV (n=14) underwent sham manipulation as the control group
|
Randomized Controlled Trials
|
What is the study measuring?
Primary Outcome Measures
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.
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)
June 1, 2023
Primary Completion (Actual)
July 31, 2023
Study Completion (Actual)
August 15, 2023
Study Registration Dates
First Submitted
October 3, 2023
First Submitted That Met QC Criteria
October 17, 2023
First Posted (Actual)
October 18, 2023
Study Record Updates
Last Update Posted (Actual)
October 18, 2023
Last Update Submitted That Met QC Criteria
October 17, 2023
Last Verified
October 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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