NCT06089772

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 3, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 18, 2023

Completed
Last Updated

October 18, 2023

Status Verified

October 1, 2023

Enrollment Period

2 months

First QC Date

October 3, 2023

Last Update Submit

October 17, 2023

Conditions

Outcome Measures

Primary Outcomes (5)

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (4)

Group I

EXPERIMENTAL

Group I (n=14) received HVLA spinal manipulation

Other: Comparing to Manipulation and Myofascial Release Techniques

Group II

ACTIVE COMPARATOR

Group II (n=14) underwent foam roller stretching,

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,

Other: Comparing to Manipulation and Myofascial Release Techniques

Group IV

SHAM COMPARATOR

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

Other: Comparing to Manipulation and Myofascial Release Techniques

Interventions

Randomized Controlled Trials

Group IGroup IIGroup IIIGroup IV

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ayça ARACI

Alanya, Antalya, Turkey (Türkiye)

Location

MeSH Terms

Conditions

PainPatient Participation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PHD, Physiotherapist, Head of Physiotherapy and Rehabilitation Department

Study Record Dates

First Submitted

October 3, 2023

First Posted

October 18, 2023

Study Start

June 1, 2023

Primary Completion

July 31, 2023

Study Completion

August 15, 2023

Last Updated

October 18, 2023

Record last verified: 2023-10

Locations