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

NCT06415825 | Not Yet Recruiting

• 1 other identifier: 757/29012024
• Study Type: interventional
• Target: 216
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

degenerative pain; spine; hip; knee; ankle; shoulder; elbow; hip and knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Preliminary muscle contraction success rate

  At baseline, at 1 month, and at 6 months.

• Manual muscle testing

  At baseline, at 1 month, and at 6 months.

• Range of motion

  At baseline, at 1 month, and at 6 months.

• Centimeter measurements

  At baseline, at 1 month, and at 6 months.

• Thomayer's test

  At baseline, at 1 month, and at 6 months.

Study Arms (2)

With pre-contr.

EXPERIMENTAL

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

Behavioral: Standard advice and Preliminary muscle contraction; Behavioral: Standard advice

Without pre-contr.

ACTIVE COMPARATOR

The patients will receive standard advice.

Behavioral: Standard advice

Interventions

Standard advice and Preliminary muscle contraction 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.

With pre-contr.

Standard advice BEHAVIORAL

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

With pre-contr.; Without pre-contr.

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Sofia: lead

Related 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.

  PMID: 24732860 BACKGROUND

• 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.

  PMID: 8689414 BACKGROUND

• 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.

  PMID: 9045348 BACKGROUND

MeSH Terms

Conditions

Back Pain; Neck Pain; Pain; Shoulder Pain; Somatoform Disorders

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Arthralgia; Joint Diseases; Musculoskeletal Diseases; Mental Disorders

Study Officials

• Assen R Aleksiev

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

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Assen R Aleksiev, MD, PhD, DMS

CONTACT

+359899401615; assen_aleksiev@doctor.com

Natali Dimitrova-Atanasova

CONTACT

+359 2 9152150; natanasova@mu-sofia.bg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants will not know which group they will be in.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Physical Medicine and Rehabilitation Department

Model Details: Both groups will receive standard advice. The maneuver group 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.

Study Record Dates

• First Submitted: March 29, 2024
• First Posted: May 16, 2024
• Study Start: May 14, 2024
• Primary Completion: May 14, 2025
• Study Completion (Estimated): May 14, 2026
• Last Updated: May 16, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The data will become available from 11.05.2025 to 11.05.2026.
• Access Criteria: The data will become available upon request from the principal investigator.