Clinical Trials Logo

Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06415825
Other study ID # 757/29012024
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date May 14, 2024
Est. completion date May 14, 2026

Study information

Verified date May 2024
Source Medical University of Sofia
Contact Assen R Aleksiev, MD, PhD, DMS
Phone +359899401615
Email assen_aleksiev@doctor.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver sub¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life.


Description:

RESEARCH OBJECTIVE: To investigate the effect of muscle preliminary contraction in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. SCIENTIFIC IDEA: Muscle latency (M1, M2, triggered response, proprioceptive visual/vestibular responses, and M3) leads to chronic damage. During the first 50-200 milliseconds of the movement, there is no internal muscular protective counterforce against external loads on discs, joints, ligaments, insertions, etc. inert structures (including arthroplastic ones), happening thousands of times a day. This leads to repetitive cumulative microtrauma with damage to the "pneumatic hammer" principle, as well as faster wear in arthroplasties. Precontraction of muscles eliminates latency and stabilizes inert (and arthroplastic) structures. WORKING HYPOTHESIS: Muscle preliminary contraction has a significant short-term and long-term effect in the rehabilitation and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty. RESEARCH METHODS: At least 216 patients with degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty, will be studied. They will be randomized into pairwise sub-groups. All will receive standard advice. The maneuver subĀ¬groups will receive additional advice - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area. The following follow-up parameters will be used: visual analogue pain scale, manual muscle testing, goniometry, centimeter, and preliminary contraction success rate. Their follow-up will be threefold - at the beginning, after 1, and after 6 months. For statistical processing, multiple analysis of variance (MANOVA), with post hoc Bonferroni multiple tests, and Pearson correlation analysis, with post hoc regression analysis, will be used. CONCLUSION: The positive results will allow the preliminary muscle contraction to be used as a universal tool in the rehabilitation, prevention, and prevention of degenerative pain in the spine, hip, knee, ankle, shoulder, elbow, and ankle joints, as well as after hip and knee arthroplasty (international contribution). This maneuver is very short (seconds), easy (everybody can perform it), does not require the allocation of time, space, and resources (including financial ones), and is instantly incorporated into everyday life.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 216
Est. completion date May 14, 2026
Est. primary completion date May 14, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria: - age over 18 years; - legal capacity; - patients with recurrent degenerative pain (at least two relapses in the last 12 months), in various joints (vertebral, hip, knee, ankle, shoulder, elbow, and knee), in an exacerbation stage (started up to 2 weeks before recruitment), occurring with periodic exacerbations and remissions (relapse duration of more than 24 hours, preceded and separated by remission of at least 1 month); - with excitatory (painful) symptoms (but without ablated ones - without paresis, paralysis, and pelvic-reservoir damage); - as well as after hip and knee arthroplasty. Exclusion Criteria: - age under 18, - incapacity; - neurological symptoms have disappeared (paresis, paralysis, and pelvic-reservoir disorders), - macro-injuries (fractures, dislocations, distortions), - structural anomalies, severe osteoporosis, infectious diseases, febrility, malignant diseases, specific inflammatory and autoimmune diseases (such as rheumatoid arthritis, ankylosing spondylarthritis, etc.), mental diseases, increased tendency to bleed (hemophilia, etc.), as well as cardiovascular vascular, respiratory, liver, kidney and metabolic damage with marked failure.

Study Design


Intervention

Behavioral:
Standard advice and Preliminary muscle contraction
The maneuver groups will receive standard advice and an additional one - preliminary contraction of the muscles in the corresponding kinesiology segment. This advice will be embedded in all motor activities of daily living involving the relevant area.
Standard advice
Standard advice includes avoiding heavy physical activity, sudden and unexpected loads, repetitive and prolonged overloads, and long periods of hypomobility.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Medical University of Sofia

References & Publications (3)

Aleksiev AR. Ten-year follow-up of strengthening versus flexibility exercises with or without abdominal bracing in recurrent low back pain. Spine (Phila Pa 1976). 2014 Jun 1;39(13):997-1003. doi: 10.1097/BRS.0000000000000338. — View Citation

Magnusson ML, Aleksiev A, Wilder DG, Pope MH, Spratt K, Lee SH, Goel VK, Weinstein JN. European Spine Society--the AcroMed Prize for Spinal Research 1995. Unexpected load and asymmetric posture as etiologic factors in low back pain. Eur Spine J. 1996;5(1):23-35. doi: 10.1007/BF00307824. — View Citation

Wilder DG, Aleksiev AR, Magnusson ML, Pope MH, Spratt KF, Goel VK. Muscular response to sudden load. A tool to evaluate fatigue and rehabilitation. Spine (Phila Pa 1976). 1996 Nov 15;21(22):2628-39. doi: 10.1097/00007632-199611150-00013. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analogue pain scale To assess the intensity of pain on a visual analog scale, a 10 centimeters segment is drawn on a piece of paper. The patient notes the intensity of pain on this line between the left end of the line (0=no pain) and the right end (10=maximum pain intensity). The result is registered in centimeters - from 0 to 10 centimeters. At baseline, at 1 month, and at 6 months.
Secondary Preliminary muscle contraction success rate Success rate refers to how often patients remember to perform preliminary muscle contraction. For example, if this maneuver is skipped every second movement (standing, sitting, bending, standing, lifting, etc.), the success rate is 50%, every third - 77%, every fourth - 85%, and so on. At baseline, at 1 month, and at 6 months.
Secondary Manual muscle testing Muscle strength is verified against the examiner's manual resistance and grading on a 0 to 5 scale accordingly: 0 - No movement; 1 - Flicker of movement; 2 - Through full range actively with gravity counterbalanced; 3 - Through full range actively against gravity; 4 -Through full range actively against some resistance; 5 - Through full range actively against strong resistance. For statistical comparability and prognostic value, this scale will be transformed into percentages of the norm: 0=0%; 1=14.29%; 2=35.72%; 3=57.14%; 4=78.57%; 5=100%. At baseline, at 1 month, and at 6 months.
Secondary Range of motion Each specific joint has a range of motion that is expressed in degrees measured by goniometer. For statistical comparability and prognostic value, the angular degrees will be transformed into percentages of the norm from 0 to 100%. At baseline, at 1 month, and at 6 months.
Secondary Centimeter measurements Centimeter measurements of circumferences of kinetic segments for verification of muscle hypotrophy - in centimeters. At baseline, at 1 month, and at 6 months.
Secondary Thomayer's test Thomayer's test is performed from a standing position with maximum flexion of the torso, bending the body forward and down with relaxed arms to the floor. The distance from the tip of the extended fingers to the floor is measured in centimeters. Inability to reach the floor with fingers is considered limited ROM (centimeters with a negative sign), when touching the floor with fingers - normal ROM (0 centimeters), and when touching the floor with palms - hypermobility (centimeters with a positive sign). At baseline, at 1 month, and at 6 months.
Secondary Schober's test Schober's test is performed from a standing position. A 15 cm descending segment from the processus spinosus of L1 (in the caudal direction) is measured and the two points are marked. Maximum flexion of the torso is performed by bending the body forward and downward. From the final flexion position, the distance between the two marked points is measured. The increase in the distance between the two points is recorded. The reference values are from 2.5 to 5 cm., i.e. under 2.5 cm. is considered hypomobility, and over 5 cm. - hypermobility. At baseline, at 1 month, and at 6 months.
Secondary Ott's test Ott's test is performed from a standing position. A 30 cm descending segment from the processus spinosus of C7 is measured (in the caudal direction) and the two points are marked. Maximum flexion of the torso is performed by bending the body forward and downward. From the final flexion position, the distance between the two marked points is measured. The increase in the distance between the two points is registered. Reference values are from 2.5 to 5 cm., i.e. under 2.5 cm. is considered hypomobility, and over 5 cm. - hypermobility. At baseline, at 1 month, and at 6 months.
See also
  Status Clinical Trial Phase
Terminated NCT03940651 - Cardiac and Renal Biomarkers in Arthroplasty Surgery Phase 4
Completed NCT05593341 - Opioid Education in Total Knee Arthroplasty N/A
Not yet recruiting NCT05290818 - Total Versus Robotic Assisted Unicompartmental Knee Replacement N/A
Withdrawn NCT04099355 - Investigating the Effect of Dronabinol on Post-surgical Pain Early Phase 1
Recruiting NCT04924205 - A Comparison Of Primary TKA Rehabilitation Using A Smart Orthotic Versus Outpatient Physical Therapy N/A
Completed NCT05399043 - Experience of Use and Biopsychosocial Effects of Robotic and Virtual Reality Devices in Neuromotor Rehabilitation N/A
Terminated NCT03185117 - Opioid Consumption After Hospital Discharge in Orthopedic Surgery
Completed NCT04118023 - 7T MRI to Evaluate Cartilage Defects in the Knee
Terminated NCT03260699 - Economic and Functional Impact of Peri-Operative Bracing for Primary Total Knee Arthroplasty (TKA) N/A
Recruiting NCT03283878 - Antibiotic Prophylaxis in Patients Undergoing Elective TKA- Multi-center Trial Phase 4
Completed NCT03133481 - Adductor Canal Block Versus Femoral Nerve Block for Total Knee Arthroplasty Phase 3
Active, not recruiting NCT04684160 - Comparison of Joint Awareness Between Fixed-bearing and Mobile-bearing Total Knee Arthroplasty Using Titanium-nitride Coated Posterior-stabilized Prostheses N/A
Completed NCT03282201 - A Survey on Blood Transfusions in Major Artrhoplasty Operations
Recruiting NCT06259032 - Comparative Effect of Mechanical and Functional Alignment in Bilateral Total Knee Arthroplasty on Ankle Alignment N/A
Completed NCT02928562 - The Impaction of Exercise Training on Bone Mineral Density in Patients After Total Knee Arthroplasty N/A
Completed NCT04481711 - Total Knee Arthroplasty and Clinical Findings N/A
Recruiting NCT01135160 - Evaluation of Weight Bearing After Total Hip and Knee Replacement
Completed NCT03921034 - IPACK Nerve Block for Total Knee Arthroplasty Phase 4
Active, not recruiting NCT05248815 - Muscle Strength and Total Knee Replacement
Not yet recruiting NCT06024161 - Weight Change and the Risk of Chronic Pain Following Hip and Knee Arthroplasties