Preliminary Muscle Contraction in the Rehabilitation and Prevention of Degenerative Pain in the Locomotor System

NCT ID: NCT06415825

Last Updated: 2024-05-16

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 216 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-14
• Study Completion Date: 2026-05-14

Brief 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.

Detailed 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 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.

Conditions

Pain, Back; Pain, Neck; Pain, Hip Burning; Pain, Shoulder; Arthropathy of Knee; Arthropathy of Hip; Pain Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

With pre-contr.

The patients will receive standard advice and an additional one - preliminary contraction of the muscles in the corresponding kinesiology segment.

Group Type: EXPERIMENTAL

Standard advice and Preliminary muscle contraction

Intervention Type: BEHAVIORAL

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

Intervention Type: BEHAVIORAL

Standard advice includes avoiding heavy physical activity, sudden and unexpected loads, repetitive and prolonged overloads, and long periods of hypomobility.

Without pre-contr.

The patients will receive standard advice.

Group Type: ACTIVE_COMPARATOR

Standard advice

Intervention Type: BEHAVIORAL

Standard advice includes avoiding heavy physical activity, sudden and unexpected loads, repetitive and prolonged overloads, and long periods of hypomobility.

Interventions

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.

Intervention Type: BEHAVIORAL

Standard advice

Standard advice includes avoiding heavy physical activity, sudden and unexpected loads, repetitive and prolonged overloads, and long periods of hypomobility.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Sofia

OTHER

Sponsor Role: lead

Responsible Party

Assen Aleksiev

Head of Physical Medicine and Rehabilitation Department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Assen R Aleksiev

Role: PRINCIPAL_INVESTIGATOR

Head Department of Physical Medicne and Rehabilitation, Medical University of Sofia

Central Contacts

Assen R Aleksiev, MD, PhD, DMS

Role: CONTACT

assen_aleksiev@doctor.com

+359899401615

Natali Dimitrova-Atanasova

Role: CONTACT

natanasova@mu-sofia.bg

+359 2 9152150

References

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.

Reference Type: BACKGROUND

PMID: 24732860 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8689414 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9045348 (View on PubMed)

Other Identifiers

757/29012024

Identifier Type: -

Identifier Source: org_study_id