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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06089772
Other study ID # 61351342
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 1, 2023
Est. completion date August 15, 2023

Study information

Verified date October 2023
Source Alanya Alaaddin Keykubat University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date August 15, 2023
Est. primary completion date July 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 45 Years
Eligibility 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 Design


Intervention

Other:
Comparing to Manipulation and Myofascial Release Techniques
Randomized Controlled Trials

Locations

Country Name City State
Turkey Ayça ARACI Alanya Antalya

Sponsors (1)

Lead Sponsor Collaborator
Alanya Alaaddin Keykubat University

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 - right after the intervention
Primary 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. Baseline - right after the intervention
Primary 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 Baseline - right after the intervention
Primary 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 Baseline - right after the intervention
Primary 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. Baseline - right after the intervention
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