Manipulation, PsychologicHVLANCT06089772
Manipulation and Myofascial Techniques On Sacroiliac Joint Dysfunction
A study testing Comparing to Manipulation and Myofascial Release Techniques in people with Manipulation, Psychologic and Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Manipulation, Psychologic, Pain, Performance Anxiety
- What is being tested?
- Comparing to Manipulation and Myofascial Release Techniques
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2023to 15 Aug 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Manipulation, Psychologic, Pain, Performance Anxiety, Participation, Patient, Physiotherapists
- Being tested
- Comparing to Manipulation and Myofascial Release Techniques
- Medical subject headings
- Pain, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparing to Manipulation and Myofascial Release TechniquesOther
Randomized Controlled Trials
| Study group | Role | What they receive |
|---|---|---|
| Group I | Experimental | Group I (n=14) received HVLA spinal manipulation Receives: Other: Comparing to Manipulation and Myofascial Release Techniques |
| Group II | Active comparator | Group II (n=14) underwent foam roller stretching, Receives: Other: Comparing to Manipulation and Myofascial Release Techniques |
| Group III | Active comparator | Group III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching, Receives: Other: Comparing to Manipulation and Myofascial Release Techniques |
| Group IV | Sham comparator | Group IV (n=14) underwent sham manipulation as the control group Receives: Other: Comparing to Manipulation and Myofascial Release Techniques |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline - right after the intervention
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.
Measured: Baseline - right after the intervention
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
Measured: Baseline - right after the intervention
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
Measured: Baseline - right after the intervention
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.
Measured: Baseline - right after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2023
- Study start1 Jun 2023
- Primary completion31 Jul 2023
- Study completion15 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Manipulation, PsychologicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alanya Alaaddin Keykubat University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayça Araci, Alanya Alaaddin Keykubat University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06089772
- Sponsor's protocol ID
- 61351342
- Acronym
- HVLA
- Status last verified
- Oct 2023
- First submitted
- 3 Oct 2023
- Last updated
- 18 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06089772
- Acronym / sponsor ID
- HVLA / 61351342
- Conditions
- Manipulation, Psychologic, Pain, Performance Anxiety, Participation, Patient, Physiotherapists
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Alanya Alaaddin Keykubat UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 15 Aug 2023 (actual)
- First posted
- 18 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
- 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.
| Arm | Type | Receives |
|---|---|---|
| Group I | Experimental | Other: Comparing to Manipulation and Myofascial Release TechniquesGroup I (n=14) received HVLA spinal manipulation |
| Group II | Active comparator | Other: Comparing to Manipulation and Myofascial Release TechniquesGroup II (n=14) underwent foam roller stretching, |
| Group III | Active comparator | Other: Comparing to Manipulation and Myofascial Release TechniquesGroup III (n=14) received a combination of HVLA spinal manipulation and foam roller stretching, |
| Group IV | Sham comparator | Other: Comparing to Manipulation and Myofascial Release TechniquesGroup IV (n=14) underwent sham manipulation as the control group |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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,
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comparing to Manipulation and Myofascial Release TechniquesRandomized Controlled Trials | Other | Group I, Group II, Group III, Group IV |
Primary outcome
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 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.
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
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparing to Manipulation and Myofascial Release Techniques in people with Manipulation, Psychologic and Pain, run by Alanya Alaaddin Keykubat University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Visual Analog Scale (time frame: Baseline - right after the intervention). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Oct 2023.